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Psychological advocacy towards healing (PATH): A randomized controlled trial of a psychological intervention in a domestic violence service setting

Psychological advocacy towards healing (PATH): A randomized controlled trial of a psychological... Citation: Ferrari G, Feder G, Agnew-Davies R, Bailey JE, Hollinghurst S, Howard L, et al. (2018) Psychological advocacy towards healing (PATH): A randomized controlled trial of a psychological Background intervention in a domestic violence service setting. Experience of domestic violence and abuse (DVA) is associated with mental illness. Advo- PLoS ONE 13(11): e0205485. https://doi.org/ cacy has little effect on mental health outcomes of female DVA survivors and there is uncer- 10.1371/journal.pone.0205485 tainty about the effectiveness of psychological interventions for this population. Editor: Michele Kiely, DESPR/NICHD/NIH, UNITED STATES Objective Received: March 2, 2017 To test effectiveness of a psychological intervention delivered by advocates to DVA Accepted: August 28, 2018 survivors. Published: November 27, 2018 Copyright:© 2018 Ferrari et al. This is an open Design, masking, setting, participants access article distributed under the terms of the Pragmatic parallel group individually randomized controlled trial of normal DVA advocacy Creative Commons Attribution License, which vs. advocacy + psychological intervention. Statistician and researchers blinded to group permits unrestricted use, distribution, and reproduction in any medium, provided the original assignment. Setting: specialist DVA agencies; two UK cities. Participants: Women aged 16 author and source are credited. years and older accessing DVA services. Data Availability Statement: The data underlying this study cannot be made available due to ethical Intervention restrictions. The data set is held in the University of Eight specialist psychological advocacy (SPA) sessions with two follow up sessions. Bristol data archive with restricted access to protect the safety of trial participants (victims of domestic violence). See: https://data.bris.ac.uk/ Measurements data/dataset/1yng1al60vsnr282q4rmc5atxg Primary outcomes at 12 months: depression symptoms (PHQ-9) and psychological distress Funding: This paper presents independent (CORE-OM). Primary analysis: intention to treat linear (logistic) regression model for contin- research funded by the United Kingdom National Institute for Health Research (NIHR) under its uous (binary) outcomes. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 1 / 17 PATH trial for domestic violence survivors Programme Grants for Applied Research scheme Results (RP-PG-0108-10084). https://www.nihr.ac.uk/ 263 women recruited (78 in shelter/refuge, 185 in community), 2 withdrew (1 community, funding-and-support/funding-for-research-studies/ how-to-apply-for-funding/. This research was control group; 1 intervention, refuge group), 1 was excluded from the study for protocol vio- supported by the NIHR Biomedical Research lation (community, control group), 130 in intervention and 130 in control groups. Recruitment Centre at University Hospitals Bristol NHS ended June 2013. 12-month follow up: 64%. At 12-month follow up greater improvement in Foundation Trust and the University of Bristol. mental health of women in the intervention group. Difference in average CORE-OM score Authors on the programme grant application: GeF, TJP, SH, RAD, DS. Domestic Violence Training Ltd between intervention and control groups: -3.3 points (95% CI -5.5 to -1.2). Difference in provided support in the form of salary to author average PHQ-9 score between intervention and control group: -2.2 (95% CI -4.1 to -0.3). At AD. The specific role of this author is articulated in 12 months, 35% of the intervention group and 55% of the control group were above the the ’author contributions’ section. Authors on the CORE-OM -2clinical threshold (OR 0.32, 95% CI 0.16 to 0.64); 29% of the intervention programme grant application: GeF, TJP, SH, RAD, DS. The views expressed in this publication are group and 46% of the control group were above the PHQ-9 clinical threshold (OR 0.41, 95% those of the authors and not necessarily those of CI 0.21 to 0.81), the National Health Service, the National Institute of Health Research, or the Department of Health and Social Care. The funder had no involvement in Limitations study design, data collection and analysis, decision 64% retention at 12 months to publish, or preparation of the manuscript. Authors on the programme grant application: GeF, TJP, SH, RAD, DS. Domestic Violence Training Ltd Conclusions provided support in the form of salary to author An eight-session psychological intervention delivered by DVA advocates produced clinically AD. The specific role of this author is articulated in relevant improvement in mental health outcomes compared with normal advocacy care. the ’author contributions’ section. The views expressed in this publication are those of the authors and not necessarily those of the National Trial registration Health Service, the NIHR, or the Department of ISRCTN registry ISRCTN58561170 Health. The funders had no role in study design, data collection and analysis, decision to publish, or Original Research preparation of the manuscript. Authors on the 3675/3750 programme grant application: GeF, TJP, SH, RAD, DS. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. The funder had no involvement in study design, conduct or analysis. Introduction Competing interests: The authors of this Domestic violence and abuse (DVA) is a common violation of human rights that damages manuscript have the following competing interests: physical and mental health. DVA can be physical, sexual, psychological and economic, perpe- If the PATH intervention was implemented in trated by a partner, ex-partner or adult family member. Intimate partner violence (IPV) is a service settings, Davies would receive payment for type of DVA. Although DVA is experienced by women and men, the majority of severe, training and supervising specialist psychological advocates. Domestic Violence Training Ltd repeated and sexual assaults are on women [1]. Most DVA epidemiological research has provided support in the form of salary to author focused on the impact of intimate partner violence (IPV), a major contributor to the global AD. burden of disease for women of reproductive age [2]. The main long term association of IPV is mental illness, with a three-fold risk of depressive disorders, four-fold risk of anxiety disorders and a seven-fold risk of post-traumatic stress disorder (PTSD) [3]. A meta-analysis of longitu- dinal studies has established a causal relationship between IPV and depression and suicide attempts [4]. Psychological interventions, such as counselling and cognitive behavioural therapy (CBT) that are not adapted to the specific needs of DVA survivors often fail to meet their needs [5]. Psychological interventions may not directly address the violence, and couple or family ther- apy, in which victim and perpetrator are treated together, are potentially dangerous. Survivors of DVA have found it unhelpful when interventions do not recognise trauma, make the abuser invisible by focusing exclusively on the mental health of the victim, (implicitly or explicitly) PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 2 / 17 PATH trial for domestic violence survivors blame the victim for the abuse or her reaction, offer medication rather than counselling and when a psychiatric diagnosis negatively impacts on care or child contact proceedings [6]. In contrast, women identify that interventions can be helpful when they are directly asked about their experiences of DVA, encouraged to name the abuse, helped with safety planning or par- enting and offered support to recover from their experiences [7]. There is uncertainty about the effectiveness of psychological interventions designed for sur- vivors of DVA delivered by counsellors or psychotherapists. The systematic review [8] under- pinning the 2014 UK National Institute for Health and Care Excellence (NICE) guidelines [9] found two randomized controlled trials of brief psychological interventions for IPV survivors in a refuge and for pregnant women respectively. The former [10], CBT-based, reported improvement in PTSD symptoms; the latter [11], psychotherapy-based, did not. The NICE review also reported four other randomized controlled trials testing cognitive processing, CBT and group therapy, reporting improvement in PTSD and depressive symptoms, but only one study compared the intervention group with a control group with no psychological interven- tion. Two trials by Kubany and colleagues [12, 13] not included in that review reported reduced post-traumatic stress symptoms following an individual cognitive therapy based inter- vention in DVA survivors who were no longer in abusive relationships. However, the results from those studies cannot be extrapolated to women suffering from other mental health condi- tions nor to women still subject to abuse. The World Health Organisation intimate partner violence and sexual violence guidelines [14] recommend trials with sufficient statistical power to assess the effectiveness of different models of psychological intervention/therapy for women survivors of intimate partner violence in a variety of settings. The NICE DVA guidelines [9] recommend research on the effectiveness of psychological interventions modified for domestic violence and abuse in the short, medium and long term, across various levels of risk and including diverse and marginalised groups and programmes for those who have suffered mul- tiple forms of abuse and those who are still experiencing it. In the United States, with the advent of universal screening for IPV in health care settings, there is a renewed emphasis on effective interventions for women disclosing abuse. In the United Kingdom, domestic violence advocacy or support is provided by a network of specialist DVA services, most affiliated to the Women’s Aid Federation (http://www. womensaid.org.uk/). Advocates engage with individual clients who are being or have been abused, aiming to increase their safety, empower them and link them to community services. The core activities of advocacy are provision of legal, housing and financial advice, facilitating access to and use of community resources such as refuges or shelters, emergency housing, pro- vision of safety planning advice, and ongoing support. The duration and intensity of advocacy varies within and between agencies. Generally advocates do not have a background or training in psychological therapies and do not provide counselling or other therapies. While advocacy may reduce recurrence of violence, its effect on mental health or quality of life is uncertain [15]. Given the contact that advocates have with women who have recently experienced DVA and their understanding of the context of abuse, they are a potential source of psychological support to survivors who seek help from the DVA agencies. Agnew-Davies and colleagues developed a specific intervention for this population delivered by DVA advocates given addi- tional training. The Psychological Advocacy Towards Healing (PATH) intervention is based on concepts and technical strategies drawn from cognitive-behavioural, experiential, dynamic, psycho-educational and feminist theories [16]. This model was evaluated in a before-and-after pilot with a sample of 106 women within refuge (shelter) settings, showing a reduction in par- ticipants’ psychological distress [17]. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 3 / 17 PATH trial for domestic violence survivors In this paper we report a trial of the PATH intervention in DVA service settings for women in refuges or community-based programmes, testing its clinical effectiveness in terms of men- tal health outcomes. Methods Ethics and governance The PATH trial was approved by the South West 4 (Southmead) Research Ethics Committee, part of the National Research Ethics Service, and site-specific approvals were received from that committee and the South Wales Research Ethics Committee. The conduct of the trial was overseen by an independent Trial Steering Committee (TSC), and an independent Data Moni- toring and Ethics Committee (DMEC) that reviewed safety and outcome data throughout the trial. Trial Registration: ISRCTN58561170 (http://www.isrctn.com/ISRCTN58561170). The application for trial registration was submitted to ISRCTN registry on 23.02.2011. Registration was delayed because ISRCTN suggested a fee waiver for National Institute for Health Research funded studies that are adopted into the NIHR portfolio. The adoption process was unexpect- edly lengthy and delayed the finalisation of ISRCTN registration, confirmed on 26 July 2011. Study design and participants This is an open, pragmatic or effectiveness (conducted in “real world” circumstances), two par- allel group individually randomized controlled trial. The research team, including the statisti- cians who analysed the outcomes (GFer and TJP), were blind to group assignment. Group assignment was kept in a randomisation database, separate from the analysis database. The randomisation database was only accessible to the trial data manager. The trial manager gener- ated and shared proxy participant IDs and group labels for analysis, and only revealed IDs and random assignment following completion of the analysis, during a meeting between research- ers and DVA agencies when results were first announced. Women seeking help from specialist DVA agencies were randomized with a 1:1 ratio to usual DVA agency support (advocacy alone) or usual DVA agency support plus a psychological intervention from an advocate or support worker with additional training: a specialist psychological advocate (SPA). Partici- pants were enrolled in the study for one year, during which time they had access to usual sup- port from the DVA agency. Eligible participants were women aged 16 years or older experiencing DVA which had led them to seek help from one of the recruiting sites. Exclusion criteria: having a psychotic illness, severe drug or alcohol problem; being unable to read English; currently attending counselling, cognitive behaviour therapy or other psychological treatments. Recruitment took place at two DVA agencies in England and Wales, respectively: Bristol Next Link (http://www.nextlinkhousing.co.uk/) and Cardiff Women’s Aid (http://www. cardiffwomensaid.org.uk/). All women who presented to these agencies were assessed for eligi- bility by the intake worker and invited to consider participation. A woman potentially inter- ested in participating was referred to a researcher who met with her at a safe location. Informed consent was obtained from the woman in writing if she agreed to participate. After consenting her to the study, the researcher and participant agreed an individualised contact sheet with safety information and details of locators: friends, family or associates who would be able to help the researcher contact the woman. The participant was then asked to complete a booklet of baseline questions. On completion, the participant was randomized to either receiving the PATH intervention or to the control group through a remote independent auto- mated telephone randomisation service provided by the Bristol Randomised Trials Collabora- tion (http://www.bristol.ac.uk/social-community-medicine/centres/brtc/). Randomisation was PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 4 / 17 PATH trial for domestic violence survivors stratified by urban area and whether women received support from the refuge/safe house or community based teams in the agencies. Allocation was concealed from the researcher until the moment of randomisation. Over the course of the study women were asked to self-complete three further question- naire booklets four, eight and twelve months post-randomisation. Questionnaires were either hand-delivered or sent in the post. Participants were given shopping vouchers for question- naire completion. Researchers made contact with participants at two, six and ten months post- randomization. Women were reminded either by text, telephone, or post to return question- naires at two, four and six weeks after questionnaire postal dispatch or hand-delivery. If researchers failed to contact a woman on four consecutive occasions, or the questionnaire was not returned by week seven, the researcher used the women’s locator contacts. Researchers continued to prompt women (or their locators) for the return of questionnaire until week twelve, after which the questionnaire was classified as missing. We issued the next question- naire in the series even when the previous questionnaire(s) was not returned. Returned ques- tionnaires were checked for completeness and entered into the database. Intervention and comparator Specialist psychological advocacy (SPA). Specialist psychological advocates (SPAs) received a 25-day manualised training programme (available from authors) developed by Agnew-Davies. The training addressed the psychological impacts of DVA on women and developed therapeutic skills specifically tailored for this client group. SPAs were trained to work with common presenting problems within a single session model [18], using a session structure based on the work of Daldrup and colleagues [19]. Topics included post- traumatic stress, depression, anxiety, low self-esteem, unresolved anger and managing loss. SPAs were also provided with handouts and self-help resources that could be used with their clients. Supervision was provided by Agnew-Davies, who listened to a sample of recorded SPA sessions and provided feedback through regular telephone or email contact and monthly face-to-face meetings. Participants in the intervention arm were assigned a SPA with the aim of receiving eight 1:1 SPA sessions (of one hour duration) that alter- nated with regular advocacy sessions, meeting either weekly or fortnightly with a further two ‘booster’ sessions, one and three months later. During SPA sessions the advocates used a variety of primarily cognitive behavioural psychological techniques focusing within any one session on a specific presenting problem, such as hyper-arousal, sleep difficulties or parenting problems. The SPA aimed to empower the participant to apply therapeutic strategies such as relaxation, challenging thoughts or goal setting, to promote recovery from each problem. In addition to the SPA sessions, women in the intervention group received usual care from their advocate. Usual care. Participants in the advocacy alone group had access to the usual DVA agency support and advocacy, including safety planning, assistance with health and social issues housing problems, budgeting and debt, and legal proceedings. They did not receive SPA sessions and their advocate did not receive specialist training in psychological meth- ods. The length of time a woman was engaged with a DVA agency varied depending on their needs and the service’s policies. The intensity and duration of advocacy support varied. Primary outcomes Clinical Outcomes in Routine Evaluation–Outcome Measure [20] (CORE-OM): 34 questions measuring global psychological distress, with sensitivity to change, good test-retest reliability PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 5 / 17 PATH trial for domestic violence survivors and UK normative data. It was designed to assess efficacy and effectiveness across multiple dis- ciplines offering psychological therapies [21]. We used it as a continuous measure (mean score) and as a dichotomous measure (clinical cut-off score� 9.9) [22]. Patient Health Questionnaire [23](PHQ-9): nine question measuring symptoms of depres- sion, with sensitivity to change and extensive validation in diverse populations. We used it as a continuous measure (mean score) and as a dichotomous measure (clinical cut-off score� 10 consistent with major depression) [24]. The decision on 11 March 2011 to promote this mea- sure from a secondary to a primary outcome was taken on the recommendation of our TSC and DMEC, and was implemented before the first patient was recruited. Secondary outcomes Generalized Anxiety Disorder questionnaire [25] (GAD7): seven questions measuring symp- toms of anxiety, with sensitivity to change, and a score� 10 consistent with a clinical diagnosis of generalised anxiety disorder [26]. PTSD Symptom Scale (PSS) [27] 17 questions measuring post-traumatic stress symptoms with a score�17 consistent with a clinical diagnosis of PTSD [28]. Short form-12 [29] (SF-12): 12 item acute form quality of life measure with physical and mental health subscales. Higher SF-12 scores correspond to better health states. Composite Abuse Scale [30](CAS): 30 questions measuring recent emotional, physical, and severe abuse, as well as harassment, with good sensitivity to change and robust psychometric properties, with increased use in DVA trials [31–33]. We used the CAS to measure both IPV and non-IPV DVA. For this analysis, if a participant was exposed to both types of DVA, we used the larger item score in calculating the total CAS score at each time point. All primary and secondary outcomes were measured at 4, 8 and 12 months. Data from the PHQ-9 and CORE-OM at 4 and 8 months were treated as secondary outcomes and used for imputation in the absence of the relevant 12 month outcome, because they are clearly corre- lated with it. We assessed how much contact participants in both intervention and control groups had with their advocate (SPA or non-SPA). Serious adverse events This information was collected and recorded by self-report from the participant, either ver- bally or in the questionnaire booklet, or elicited by the DVA advocate or SPA following contact with the participant. All serious adverse events were reported to the data monitoring and ethics committee (protocol available from authors). Sample size An effect size of 0.4 to 0.5 is consistent with those detected in studies of psychological interven- tions using the CORE-OM as an outcome measure [34] and is consistent with findings for CBT interventions on PHQ-9 and other measures of depression [35]. Two hundred partici- pants gives a power of 96% to detect a difference of 0.5 on the CORE-OM (a “reliable change index” [36]), corresponding to an effect size of 0.5, and 81% power to detect an effect size of 0.4. Assuming an attrition of 20%, we aimed to recruit 250 women. Statistical analysis As specified in advance for the primary analyses at 12 months, we analysed groups as rando- mised, conducting linear regression analyses for continuous, and logistic regression analyses for binary outcomes. These models were used for primary and secondary outcomes at 12 PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 6 / 17 PATH trial for domestic violence survivors months from randomisation (labelled intention-to-treat, or ITT, here). We adjusted for site (Bristol or Cardiff) and setting (safe house/shelter or community). We did not need to adjust for imbalance in baseline scores of the characteristics of the groups. We adjusted for baseline values of the outcome variables to increase the precision of our estimates. We conducted our pre-specified subgroup analyses by site, setting and age [37], by introducing the relevant inter- action effect in our regressions models [38]. As specified in our protocol [37], we investigated whether including participants lost to follow up alters our estimates of effectiveness in sensitiv- ity analyses based on multiple imputation by chained equation models (mice) for the main model [39]. We generated 100 imputed datasets using a mice model with all outcome variables at all time-points, in addition to the variables included in the model for the main analysis (treatment arm plus stratification by urban area and setting). We did not include socio-demo- graphic variables in the mice model, because they did not predict missingness for individual variables. We calculated complier-average causal effects (CACE) using instrumental variables regression techniques to explore a causal link between assignment to treatment and impact in relation to treatment adherence (number of treatment sessions received) [40], using a mini- mum of four sessions. This analysis was specified in our protocol [37]. It supersedes the gener- alised mixed model with number of sessions as a fixed categorical effect specified in the protocol as a secondary analysis to assess stability of treatment effect [37], because an instru- mental variables-based CACE is better placed to both address and account for the issue of treatment non-adherence [41] (see S1 Text for further details). We assessed fidelity of the intervention by listening to a stratified random sample of audio- files. A fidelity scale (available from the authors) was developed to measure adherence of SPAs to the PATH model. The scale was adapted from a revised version of the Cognitive Therapy Scale (CTS-R) [42], a widely used measure of competence in CBT, and was used to rate the content of the audiotapes. We have published details of the trial design [37]. The cost-effectiveness analysis will be reported in a separate paper. Funding and conflict of interest This paper presents independent research funded by the United Kingdom National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-0108-10084). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. The funder had no involvement in study design, conduct or analysis. If the PATH intervention was implemented in service settings, Agnew-Davies would receive payment for training and super- vising SPAs. The other authors declare no conflicts of interest. Results We report on the analysis of the primary and secondary outcomes at the primary follow up point of 12 months, between the two groups of women as randomised (ITT). Trial flow and baseline characteristics Between April 2011 and May 2013 we obtained consent and randomized 263 participants: 24% of eligible women seeking help from the two participating DVA agencies (1096), 51% of women who consented to be contacted by a researcher (513), and 83% of women who met with a researcher to discuss participation (317). 64% of participants were retained for the full 12 month follow up period to the end of the trial, although we had primary outcome data from any follow up time point available for 78% of participants (78% SPA group, 77% advocacy PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 7 / 17 PATH trial for domestic violence survivors Fig 1. CONSORT diagram illustrating participants‘ flow through the various stages of the trial data collection process. https://doi.org/10.1371/journal.pone.0205485.g001 alone group). In some cases, it was impossible to establish the reason for loss to follow up, as women had also lost contact with the collaborating agencies (Fig 1). The vulnerability and mobility of women experiencing DVA makes follow up in longitudinal studies challenging [43, 44]. Women lost to follow up were more likely to have been in refuges: 42% lost to follow up, versus 23% lost to follow up among women who were not in a refuge. This would be expected, because women who leave their home for a refuge are more likely to subsequently leave the local area. However, all other socio-demographic characteristics and outcomes did not differ between women lost to follow up and women who remained in the study (S1 Table). In addi- tion, in terms of socio-demographic characteristics or outcomes, women lost to follow up in the control group (N = 43) were comparable to women lost to follow up in the intervention group (N = 47). The SPA group and advocacy alone group had similar characteristics at baseline (Tables 1 and 2, with more details available elsewhere[45]). Of the 120/130 participants in the SPA group for whom we have information on adherence, 54 (45%) attended fewer than four sessions, and 66 (55%) attended four or more, which we pre-specified as reflecting adequate adherence. Implementation partners also shared records PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 8 / 17 PATH trial for domestic violence survivors Table 1. Baseline characteristics of participants–socio-demographics, alcohol and substance misuse, childhood and abuse. Treatment Group Control Group Characteristics Respondents Mean (SD) Proportion of Respondents Mean (SD) Proportion of Range (min, respondents (%) Range (min, respondents (%) max) max) Age 123 33 (11) 126 34 (10) (18, 67) (18, 65) White British or other white background 106/126 (84) 113/127 (89) Who completed secondary education 96/116 (83) 97/117 (83) Whose yearly income is at least $17,710 16/69 (23) 28/87 (32) Hazardous drinking (Audit-C> = 3) 70/126 (56) 65/125 (52) Smoked cannabis in past 12 months 36/124 (29) 28/121 (23) Made use of type A drugs 11/127 (9) 9/125 (7) Currently in a relationship 26/127 (20) 25/123 (20) Is parent 97/125 (78) 109/129 (84) Has child under 4 years living with her 49/130 (38) 47/130 (36) Perpetrator is a current partner 29/118 (25) 26/118 (22) Work in the household 46/116 (40) 43/121 (36) Not in formal employment (excl retirees 90/115 (78) 93/121 (77) and students) Witnessed DVA as a child 66/129 (51) 67/128 (52) Abused as a child 65/129 (50) 64/128 (50) GBP to USD conversion rate, Nov 01 2012 (source: http://www.oanda.com/currency/converter/) Heroin (diamorphine), cocaine (including crack), methadone, ecstasy (MDMA), LSD, and magic mushrooms https://doi.org/10.1371/journal.pone.0205485.t001 of participants’ attendance at advocacy sessions for all participants. These data show that the average number of advocacy sessions was 5.8 (SD 6.6) for control group participants (N = 124), and 7.2 (SD 6.8) for SPA clients (N = 95). Fig 2 illustrates the flow of women through the intervention. More than half of the 120 for whom we have attendance records attended four or more of the sessions. One third attended all eight sessions. Thirty-five women also attended the first booster session, and 26 attended both booster sessions. Primary outcomes Table 2 shows a 3.3 point lower mean CORE-OM score and a 2.2 point lower mean PHQ-9 score between the SPA and the advocacy group at 12 months’ follow up. 35% of the SPA group and 55% of the advocacy alone group were above the clinical threshold for the CORE-OM at 12 months respectively (odds ratio 0.32, 95% confidence interval 0.2 to 0.6), with proportions at baseline of 78% and 74% respectively. 29% of the SPA group and 46% of the advocacy alone group were above the clinical threshold for the PHQ-9 at 12 months respectively (odds ratio 0.4, 95% confidence interval 0.2 to 0.8). Trends in the CORE-OM and PHQ-9 score over the 12-month period post randomisation suggest that the intervention group experiences a sharper improvement in mental health four months post recruitment, compared with the con- trol group. Both groups remain stable around the initial reductions over the intervening eight months, suggesting that intervention participants sustain the relative improvement (S1 Fig). Secondary outcomes The PTSD score is lower in the SPA than in the advocacy alone group after 12 months and the proportion of women below the clinical threshold for PTSD is also lower in the SPA group. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 9 / 17 PATH trial for domestic violence survivors Table 2. Baseline characteristics of participants–domestic abuse and mental health. SPA Control Characteristics Respondents Mean (SD) Proportion of Respondents Mean (SD) Proportion of Range (min, respondents (%) Range (min, respondents (%) max) max) Composite Abuse Scale (CAS) Total abuse (total score CAS, continuous) 129 59 (35) 129 58 (35) (0, 138) (0, 150) Total abuse (total score CAS> = 3) 124/129 (96) 124/129 (96) Severe abuse (severity CAS> = 1) 89/129 (69) 94/129 (73) Emotional abuse (emo CAS> = 3) 122/129 (95) 123/129 (95) Physical abuse (physical CAS > = 1) 119/129 (92) 117/129 (91) Harassment (harassment CAS> = 2) 113/129 (88) 109/129 (84) Abused by a family member (not intimate 41/125 (33) 42/127 (33) partner) Abused for more than 5 years (includes IPV and 28/117 (24) 41/121 (34) other domestic abuse) Past year experience of abuse (includes IPV and 105/117 (90) 112/120 (93) other domestic abuse) CORE-OM clinical 130 18 (8) 129 18 (7) (1, 35) (2, 35) PHQ-9 130 15 (8) 128 14 (7) (0, 27) (0, 27) GAD7 129 13 (6) 126 13 (6) (0, 21) (0, 21) PTSD 130 27 (12) 126 26 (11) (0, 51) (0, 51) SF12physical 113 48 (12) 123 49 (12) (21, 68) (15, 71) SF12mental 113 31 (14) 123 31 (13) (4, 67) (6, 62) Note: ‘SPA’ refers to women randomly selected to attend the specialist psychological advocacy treatment. ‘Control’ refers to women randomised to the usual care advocacy group. https://doi.org/10.1371/journal.pone.0205485.t002 Fig 2. Minimum number of SPA sessions attended. Bars show the number of treated clients attending none, or at least the stated number of sessions. https://doi.org/10.1371/journal.pone.0205485.g002 PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 10 / 17 PATH trial for domestic violence survivors Table 3. Differences in primary outcomes at 12 months. Variable SPA Control Beta Variable SPA Control aOR mean (sd) mean (sd) (95% CI) (n /N ) (n /N ) 1 1 2 2 Continuous Measures Binary Measures Primary Outcomes CORE-OM clinical 11.3 (8.6) 14.2 (7.9) -3.3 CORE-OM caseness 30/84 46/83 0.32 (-5.5, -1.2) (0.16, 0.64) p value 0.003 p value 0.001 N 84 83 166 N 166 PHQ-9 7.1 (7.0) 8.9 (6.4) -2.2 PHQ-9> = 10 24/83 38/83 0.41 (-4.1, -0.3) (0.21, 0.81) p value 0.021 p value 0.010 N 83 83 165 N 165 Secondary Outcomes Measures of Mental Health PTSD 15.5 (12.9) 18.9 (12.6) -3.9 PTSD> = 17 36/87 47/83 0.50 (-7.3, -0.52) (.25, .99) p value 0.024 p value 0.047 N 87 83 168 N 168 GAD7 6.2 (6.1) 7.4 (5.7) -1.4 GAD7> = 10 24/83 24/83 0.95 (-3.1, 0.36) (0.47, 1.9) p value 0.12 p value 0.88 N 83 83 163 N 163 Measures of Health State SF12 40.5 (15.6) 36.2 (14.0) 4.6 Mental (0.050, 9.2) p value 0.048 N 82 81 150 SF12 47.4 (11.0) 48.5 (12.1) -0.41 Physical (-3.42, 2.6) P value 0.79 N 82 81 150 Measure of Abuse (IPV or non-IPV) Domestic abuse 16.5 (28.9) 21.9 (29.7) -5.1 Abuse cases 37/81 49/82 0.56 (-13.9, 3.7) (0.30, 1.05) p value 0.251 p value 0.071 N 161 N 161 Note: beta is the coefficient on the treatment (SPA) variable in the linear regression models for continuous outcomes; aOR are adjusted odds-ratios from the logistic regressions for binary outcomes. ‘SPA’ refers to women randomly selected to attend the specialist psychological advocacy treatment. ‘Control’ refers to women randomised to the usual care advocacy group. Estimates are adjusted for site (Bristol or Cardiff) and setting (safe house/shelter or community), as well as baseline values of the relevant outcome variable. https://doi.org/10.1371/journal.pone.0205485.t003 However, there was no evidence of a difference in GAD-7 score nor the proportion of women below the clinical threshold (Table 3). The SF-12 mental health score is higher in the SPA group, and there is no evidence for a difference in the SF-12 physical health score. There is no evidence of a difference in total exposure to further abuse. Pre-specified secondary analyses For primary and secondary outcomes, the multiple imputation for missing data gave lower point estimates for differences between intervention and control groups, although all were PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 11 / 17 PATH trial for domestic violence survivors within the 95% confidence intervals of the complete case analysis (S2 Table). The imputations for binary outcomes yielded very similar odds ratios to the complete case analysis (S2 Table). The CACE analysis results in roughly a doubling of the effect of the intervention across mental health and abuse variables, consistent with greater benefit for those participants attending a sufficient number of SPA sessions (S2 Table). The fidelity analysis (details available from the authors) shows that SPAs broadly adhered to the session structure and the working alliance with participants, as specified in the PATH manual and training. The subgroup analyses found no evidence of interaction effects between treatment and age, site and setting (S3 Table). Serious adverse events 22 women (15 in the SPA group, seven in the advocacy alone group) reported a total of 32 seri- ous adverse events (Table 4). For three women (four events) in the intervention group, it was unclear from the information available whether the SAEs were related to trial participation. These events were reported to the NHS research ethic committee (REC) that had approved the study, following advice from the chair of our study’s independent Data Monitoring & Ethics Committee. The REC judged that nochanges to the conduct of the intervention or trial were necessary. None of the remaining 28 SAEs (19 women) were related to trial participation. Most of the serious adverse events were hospital admission due to physical or mental ill health. This included six cases of attempted suicide, seven cases related to pregnancy or miscarriage, three cases of injuries from physical assault, ten cases of chest or abdominal pain and two planned admissions. Planned admissions and injuries from physical assault were only found in the intervention arm. All other non-miscellaneous categories occurred with a similar fre- quency in both arms. Conclusions This study is the first randomized controlled trial of an intervention to improve mental health symptoms of women experiencing DVA delivered by advocates with additional training in psychological methods. The PATH intervention, unlike the majority of psychological treat- ments for survivors of DVA, which are delivered by psychologists or counsellors, is based on a relatively brief training of advocates already in the DVA sector with ongoing supervision by a psychologist. Table 4. Serious adverse events by randomisation arm. SAE type Random assignment SPA (N) Control (N) Attempted suicide 4 2 Planned 2 0 Pregnancy-related 5 2 Injuries from physical assault 3 0 Chest/abdominal pain 7 3 Other 2 2 Total 23 9 Note: ‘SPA’ refers to women randomly selected to attend the specialist psychological advocacy treatment. ‘Control’ refers to women randomised to the usual care advocacy group. https://doi.org/10.1371/journal.pone.0205485.t004 PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 12 / 17 PATH trial for domestic violence survivors We found that the primary outcomes of psychological distress and symptoms of depression were reduced in both arms compared to baseline, with evidence of a difference between the groups at 12 months follow up. This was also the case for post-traumatic stress symptoms and a general measure of mental health state (SF-12mental), but not anxiety or experience of fur- ther abuse. Although the differences in mean scores for the primary outcomes between the groups are relatively modest, there are clinically important differences in the primary outcomes expressed as proportions of participants in the intervention and control groups with depression and with psychological distress. The treatment effect is reduced with imputation for missing data and increased in those participants attending more SPA sessions. A judgement about whether the extent of benefit justifies implementation of the PATH intervention needs to take into account the findings of the nested qualitative study, reported in the accompanying qualitative paper (see Evans et al., DOI: 10.1371/journal.pone.0193077), that explores the experiences of participants. The four SAEs in which the relation to trial participation was uncertain occurred in the control group. The greater number of SAEs over all recorded in the intervention group was probably due to greater contact with DVA advocates. Strengths and limitations Strengths of PATH include: recruitment of a sizeable proportion of the eligible women experiencing abuse and seeking help [46]; successful collaboration with agencies in the DVA sector to deliver a psychological intervention with reasonable fidelity; relatively complete data collection from participants retained in the trial; outcome data from at least one time point after randomisation from 74% of participants; and a nested longitudinal qualitative study (see Evans et al., DOI: 10.1371/journal.pone.0193077). The main limitation threatening the internal validity of the trial is the 34% loss of participants 12 months post-intervention, requiring pre- specified imputation of the missing outcome data. The main limitation threatening its external validity is the proportion of eligible women who did not participate, including those who wanted counselling and potentially most likely to respond to the intervention. Finally, this was a “real world” pragmatic trial, where intervention participants had higher levels of contact with services because they accessed SPA treatment in addition to usual care. The absence of an attention control group means we cannot exclude the possibility that the additional contact was responsible for the treatment effect. However, our IV results in conjunction with advo- cates’ adherence to the treatment model (see fidelity analysis) provides support for the hypoth- esis that the increased effectiveness deriving from attendance may be explained by the treatment, rather than more exposure to advocates. Comparison with other studies The standardised effect size of the SPA intervention (0.4 for CORE-OM and 0.32 for PHQ-9) is similar to the effect of psychological treatment for depression in primary care [47]. The effect on mental health outcomes is comparable to other trials of psychological interventions for sur- vivors of DVA measuring treatment impact on trauma-related mental health symptoms or wellbeing, as systematically reviewed by Warshaw and colleagues [48]. Five of the nine studies in that review were CBT-based interventions for women who were experiencing IPV and three were targeted at women with additional conditions: suicidality, substance abuse or preg- nancy. All the interventions were delivered by trained therapists, whereas the PATH interven- tion was delivered by domestic violence advocates with relatively brief training, but ongoing supervision. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 13 / 17 PATH trial for domestic violence survivors Implications of findings The PATH intervention delivered by specialist psychological advocates can improve psycho- logical distress and depressive symptoms in women survivors of DVA, the majority of whom had experienced IPV. The findings of the trial and of the nested qualitative study (see Evans et al., DOI: 10.1371/journal.pone.0193077) show heterogeneity in response to the intervention; further abuse, experienced by a large minority of participants, possibly attenuated its effect. These findings from a pragmatic trial can be implemented in DVA agency settings that already employ advocates, if they undergo further training. Supporting information S1 Table. Participants successfully followed up at 12 months vs participants who were not, baseline characteristics. (DOCX) S2 Table. Complete case analysis compared with mice and CACE estimates. (DOCX) S3 Table. Subgroup analyses. (DOCX) S4 Table. CONSORT checklist PATH. (DOC) S1 Fig. Main outcomes, time trends. (DOCX) S1 Text. Methodological discussion of the instrumental variables estimates for PATH. (DOCX) S2 Text. Trial of an individually randomised, parallel group controlled trial to determine if a psychological intervention delivered by domestic violence advocates is effective and cost-effective: Psychological Advocacy Towards Healing (PATH). (DOC) S3 Text. PATH protocol paper (Trials 2013). (PDF) Acknowledgments Thank you to: Gwen Brierley, first trial manager of PATH; David Carmichael, database man- ager; Carol Metters and her colleagues at Next Link; Morgan Fackrell and her colleagues at Cardiff Womens Aid. Author Contributions Conceptualization: Gene Feder, Roxane Agnew-Davies, Sandra Hollinghurst, Louise Howard, Debbie Sharp, Tim J. Peters. Data curation: Giulia Ferrari. Formal analysis: Giulia Ferrari. Funding acquisition: Gene Feder, Sandra Hollinghurst, Debbie Sharp, Tim J. Peters. Investigation: Jayne E. Bailey, Emma Howarth, Lynnmarie Sardinha. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 14 / 17 PATH trial for domestic violence survivors Methodology: Giulia Ferrari, Gene Feder, Roxane Agnew-Davies, Sandra Hollinghurst, Louise Howard, Emma Howarth, Lynnmarie Sardinha, Debbie Sharp, Tim J. Peters. Project administration: Gene Feder, Jayne E. Bailey. Supervision: Gene Feder, Roxane Agnew-Davies, Jayne E. Bailey, Sandra Hollinghurst, Louise Howard, Tim J. Peters. Visualization: Giulia Ferrari. Writing – original draft: Giulia Ferrari, Gene Feder. Writing – review & editing: Giulia Ferrari, Gene Feder, Roxane Agnew-Davies, Jayne E. Bai- ley, Sandra Hollinghurst, Louise Howard, Emma Howarth, Lynnmarie Sardinha, Debbie Sharp, Tim J. Peters. References 1. Breiding MJ, Smith SG, Basile KC, Walters ML, Chen J, MT. M. Prevalence and characteristics of sex- ual violence, stalking, and intimate partner violence victimization—national intimate partner and sexual violence survey, United States, 2011. MMWR Surveill Summ. 2014; 63(8):1–18. PMID: 25188037 2. WHO. Global and regional estimates of violence against women: prevalence and health effects of inti- mate partner violence and non-partner sexual violence. Geneva: WHO; 2013. 3. Trevillion K, Oram S, Feder G, Howard LM. Experiences of Domestic Violence and Mental Disorders: A Systematic Review and Meta-Analysis. PLoS ONE. 2012; 7(12):e51740. https://doi.org/10.1371/ journal.pone.0051740 PMID: 23300562 4. Devries KM, Mak JYT, Garcı ´a-Moreno C, Petzold M, Child JC, Falder G, et al. The Global Prevalence of Intimate Partner Violence Against Women. Science. 2013; 340(6140):1527–8. https://doi.org/10. 1126/science.1240937 PMID: 23788730 5. Ramsay J, Feder G, Rivas C. Interventions to reduce violence and promote the physical and psychoso- cial well-being of women who experience partner abuse: a systematic review. In: Health Do, editor. London2006. 6. Trevillion K, Howard LM, Morgan C, Feder G, Woodall A, Rose D. The Response of Mental Health Ser- vices to Domestic Violence: A Qualitative Study of Service Users’ and Professionals’ Experiences. Jour- nal of the American Psychiatric Nurses Association. 2012; 18(6):326–36. https://doi.org/10.1177/ 1078390312459747 PMID: 22989418 7. Humphreys C, Thiara R. Mental Health and Domestic Violence: ’I Call it Symptoms of Abuse’. British Journal of Social Work. 2003; 33(2):209–26. 8. British Columbia Centre of Excellence for Women’s Health. Review of Interventions to Identify, Prevent, Reduce and Respond to Domestic Violence2013 9th February 2016. Available from: https://www.nice. org.uk/guidance/ph50/resources/review-of-interventions-to-identify-prevent-reduce-and-respond-to- domestic-violence2). 9. (NICE) NIfHaCE. Domestic violence and abuse: how health services, social care and the organisations they work with can respond effectively.; 2014. 10. Johnson DM, Zlotnick C, Perez S. Cognitive behavioural treatment of PTSD in residents of battered women’s shelters: results of a randomized clinical trial. J Consult Clin Psychol. 2011; 79(4):542–51. https://doi.org/10.1037/a0023822 PMID: 21787052 11. Zlotnick C, Capezza NM, Parker D. An interpersonally based intervention for low-income pregnant women with intimate partner violence: a pilot study. Archives of Womens Mental Health. 2011; 14 (1):55–65. 12. Kubany ES, Hill EE, Owens JA. Cognitive trauma therapy for battered women with PTSD: preliminary findings. J Trauma Stress. 2003; 16(1):81–91. https://doi.org/10.1023/A:1022019629803 PMID: 13. Kubany ES, Hill EE, Owens JA, Iannce-Spencer C, McCaig MA, Tremayne KJ, et al. Cognitive trauma therapy for battered women with PTSD (CTT-BW). J Consult Clin Psychol. 2004; 72(1):3–18. https:// doi.org/10.1037/0022-006X.72.1.3 PMID: 14756610 14. WHO. Responding to intimate partner violence and sexual violence against women: WHO clinical and policy guidelines. Geneva: WHO; 2013. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 15 / 17 PATH trial for domestic violence survivors 15. Rivas C, Ramsay J, Sadowski L, Davidson LL, Dunne D, Eldridge S, et al. Advocacy interventions to reduce or eliminate violence and promote the physical and psychosocial well-being of women who experience intimate partner violence. Cambell Systematic Reviews. 2016; 2. 16. Agnew-Davies R. Reframing psychological symptoms in the context of domestic violence. 37th Annual Meeting Society for Psychotherapy; June 2006; Edinburgh UK2006. 17. Rees A, Agnew-Davies R, Barkham M, editors. Outcomes for women escaping domestic violence. Society for Psychotherapy Research: From research to practice; 2006. 18. Hoyt MF. Some stories are better than others. 2000 2000. 19. Daldrup R, Greenberg L, Beutler L, Engle D. Focused expressive psychotherapy: Freeing the overcon- trolled patient. London: Guildford Press; 1988. 20. Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, et al. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002; 180:51–60. PMID: 11772852 21. Barkham M, Mellor-Clark J, Connell J, J C. A core approach to practice-based evidence: a brief history of the origins and applications of the CORE-OM and CORE System. Couns Psychother Res 2006; 6:3– 22. Connell J, Barkham M, Stiles WB, Twigg E, Singleton N, Evans O, et al. Distribution of CORE-OM scores in a general population, clinical cut-off points and comparison with the CIS-R. Br J Psychiatry. 2007; 190:69–74.:69–74. https://doi.org/10.1192/bjp.bp.105.017657 PMID: 17197659 23. Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiat Ann. 2002; 32(9):509–15. 24. Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. Can Med Assoc J. 2012; 184(3):E191–E6. 25. Spitzer RL, Kroenke K, Williams JBW, Lowe B. A brief measure for assessing generalized anxiety disor- der—The GAD-7. Arch Intern Med. 2006; 166(10):1092–7. https://doi.org/10.1001/archinte.166.10. 1092 PMID: 16717171 26. Kertz S, Bigda-Peyton J, T B. Validity of the Generalized Anxiety Disorder-7 scale in an acute psychiat- ric sample. Clin Psychol Psychother. 2013; Sep-Oct( 20(5)):456–64. https://doi.org/10.1002/cpp.1802 PMID: 22593009 27. Foa EB, Riggs DS, Dancu CV, Rothbaum BO. Reliability and validity of a brief instrument for assessing post-traumatic stress disorder. Journal of Traumatic Stress. 1993; 6:459–73. 28. Griffing S, Lewis CS, Chu M, Sage RE, Madry L, Primm BJ. Exposure to Interpersonal Violence as a Predictor of PTSD Symptomatology in Domestic Violence Survivors Journal of Interpersonal Violence 2006; 21. 29. Ware JE, Kosinski M, Turner-Bowker DM, Gandek B. User’s Manual for the SF-12v2® Health Survey (With a Supplement Documenting SF-12® Health Survey). Lincoln, Rhode Island: QualityMetric Incor- porated 2002. 30. Hegarty K, Fracgp, Bush R, Sheehan M. The composite abuse scale: further development and assess- ment of reliability and validity of a multidimensional partner abuse measure in clinical settings. Violence Vict. 2005; 20(5):529–47. PMID: 16248489 31. MacMillan HL, Wathen CN, Jamieson E, Boyle MH, Shannon HS, Ford-Gilboe M, et al. Screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2009; 302(5):493–501. https://doi.org/10.1001/jama.2009.1089 PMID: 19654384 32. Taft A, O’Doherty L, Hegarty K, Ramsay J, Davidson L, Feder G. Screening women for intimate partner violence in healthcare settings. CochraneDatabaseSystRev. 2013; 4:CD007007. https://doi.org/10. 1002/14651858.CD007007.pub2.:CD007007 PMID: 23633338 33. Glass N, Clough A, Case J, Hanson G, Barnes-Hoyt J, Waterbury A, et al. A safety app to respond to dating violence for college women and their friends: the MyPlan study randomized controlled trial proto- col. Bmc Public Health. 2015; 15:871. https://doi.org/10.1186/s12889-015-2191-6 PMID: 26350482 34. Barkham M, Stiles WB, Connell J, Twigg E, Leach C, Lucock M, et al. Effects of psychological therapies in randomized trials and practice-based studies. BrJClinPsychol. 2008; 47(Pt 4):397–415. 35. Butler A, Chapman J, Forman E, Beck A. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006; 26:17–31. https://doi.org/10.1016/j.cpr.2005.07.003 PMID: 36. Barkham M, Mellor-Clark J, Connell J, Cahill J. A core approach to practice-based evidence: A brief his- tory of the origins and applications of the COREOM and CORE System. Counselling and Psychother- apy Research. 2006; 6(1):3–15. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 16 / 17 PATH trial for domestic violence survivors 37. Brierley G, Agnew-Davies R, Bailey J, Evans M, Fackrell M, Ferrari G, et al. Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial. Trials. 2013; 14(1):221. 38. Sun X BM, Busse JW, You JJ, Akl EA, Mejza F, Bala MM, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. British Medical Journal. 2012; 344:e1553. https://doi. org/10.1136/bmj.e1553 PMID: 22422832 39. Spratt M CJ, Sterne JA, Carlin JB, Heron J, Henderson J, Tilling K Strategies for multiple imputation in longitudinal studies. Am J Epidemiol. 2010; 172:478–87. https://doi.org/10.1093/aje/kwq137 PMID: 40. Greenland S. An introduction to instrumental variables for epidemiologists. International journal of epi- demiology. 2000; 29(4):722–9. PMID: 10922351 41. Hernan MA, Robins JM. Instruments for causal inference: an epidemiologist’s dream? Epidemiology (Cambridge, Mass). 2006; 17(4):360–72. 42. Blackburn IM, James IA, Milne DL, Baker C, Standart S, Garland A, et al. The revised cognitive therapy scale (CTS-R): psychometric properties. Behavioural and Cognitive Psychotherapy. 2001; 29(4):431– 43. Schrager J, Smith L, Heron S, Houry D. Does stage of change predict improved intimate partner vio- lence outcomes following an emergency department intervention? Acad Emerg Med. 2013 20(2):169– 77. https://doi.org/10.1111/acem.12081 PMID: 23406076 44. Houry D, Feldhaus K, Peery B, Abbott J, Lowenstein SR, Al-Bataa-De-Montero S, et al. A positive domestic violence screen predicts future domestic violence. Journal of Interpersonal Violence. 2004; 19 (9):955–66. https://doi.org/10.1177/0886260504267999 PMID: 15296611 45. Ferrari G, Agnew-Davies R, Bailey J, Howard L, Howarth E, Peters TJ, et al. Domestic violence and mental health: a cross-sectional survey of women seeking help from domestic violence support ser- vices. Global Health Action. 2016; 9(29890). 46. McGarry J, Ali P. Researching domestic violence and abuse in healthcare settings: Challenges and issues. Journal of Research in Nursing. 2016; 21(5–6):465–76. 47. Cuijpers P, van Straten A, van Schaik A, Andersson G. Psychological treatment of depression in pri- mary care: a meta-analysis. British journal of general practice. 2009;February:E51–E60. https://doi.org/ 10.3399/bjgp09X395139 PMID: 19192368 48. Warshaw C, Sullivan C, Riviera EA. Systematic Review of Trauma-Focused Interventions for Domestic Violence Survivors Washington DC: National Center on Domestic Violence, Trauma & Mental Health; PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 17 / 17 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png PLoS ONE Public Library of Science (PLoS) Journal

Psychological advocacy towards healing (PATH): A randomized controlled trial of a psychological intervention in a domestic violence service setting

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Copyright: © 2018 Ferrari et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability: The data underlying this study cannot be made available due to ethical restrictions. The data set is held in the University of Bristol data archive with restricted access to protect the safety of trial participants (victims of domestic violence). See: https://data.bris.ac.uk/data/dataset/1yng1al60vsnr282q4rmc5atxg Funding: This paper presents independent research funded by the United Kingdom National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-0108-10084). https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/how-to-apply-for-funding/. This research was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. Authors on the programme grant application: GeF, TJP, SH, RAD, DS. Domestic Violence Training Ltd provided support in the form of salary to author AD. The specific role of this author is articulated in the 'author contributions' section. Authors on the programme grant application: GeF, TJP, SH, RAD, DS. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute of Health Research, or the Department of Health and Social Care. The funder had no involvement in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Authors on the programme grant application: GeF, TJP, SH, RAD, DS. Domestic Violence Training Ltd provided support in the form of salary to author AD. The specific role of this author is articulated in the 'author contributions' section. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Authors on the programme grant application: GeF, TJP, SH, RAD, DS. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. The funder had no involvement in study design, conduct or analysis. Competing interests: The authors of this manuscript have the following competing interests: If the PATH intervention was implemented in service settings, Davies would receive payment for training and supervising specialist psychological advocates. Domestic Violence Training Ltd provided support in the form of salary to author AD.
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Abstract

Citation: Ferrari G, Feder G, Agnew-Davies R, Bailey JE, Hollinghurst S, Howard L, et al. (2018) Psychological advocacy towards healing (PATH): A randomized controlled trial of a psychological Background intervention in a domestic violence service setting. Experience of domestic violence and abuse (DVA) is associated with mental illness. Advo- PLoS ONE 13(11): e0205485. https://doi.org/ cacy has little effect on mental health outcomes of female DVA survivors and there is uncer- 10.1371/journal.pone.0205485 tainty about the effectiveness of psychological interventions for this population. Editor: Michele Kiely, DESPR/NICHD/NIH, UNITED STATES Objective Received: March 2, 2017 To test effectiveness of a psychological intervention delivered by advocates to DVA Accepted: August 28, 2018 survivors. Published: November 27, 2018 Copyright:© 2018 Ferrari et al. This is an open Design, masking, setting, participants access article distributed under the terms of the Pragmatic parallel group individually randomized controlled trial of normal DVA advocacy Creative Commons Attribution License, which vs. advocacy + psychological intervention. Statistician and researchers blinded to group permits unrestricted use, distribution, and reproduction in any medium, provided the original assignment. Setting: specialist DVA agencies; two UK cities. Participants: Women aged 16 author and source are credited. years and older accessing DVA services. Data Availability Statement: The data underlying this study cannot be made available due to ethical Intervention restrictions. The data set is held in the University of Eight specialist psychological advocacy (SPA) sessions with two follow up sessions. Bristol data archive with restricted access to protect the safety of trial participants (victims of domestic violence). See: https://data.bris.ac.uk/ Measurements data/dataset/1yng1al60vsnr282q4rmc5atxg Primary outcomes at 12 months: depression symptoms (PHQ-9) and psychological distress Funding: This paper presents independent (CORE-OM). Primary analysis: intention to treat linear (logistic) regression model for contin- research funded by the United Kingdom National Institute for Health Research (NIHR) under its uous (binary) outcomes. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 1 / 17 PATH trial for domestic violence survivors Programme Grants for Applied Research scheme Results (RP-PG-0108-10084). https://www.nihr.ac.uk/ 263 women recruited (78 in shelter/refuge, 185 in community), 2 withdrew (1 community, funding-and-support/funding-for-research-studies/ how-to-apply-for-funding/. This research was control group; 1 intervention, refuge group), 1 was excluded from the study for protocol vio- supported by the NIHR Biomedical Research lation (community, control group), 130 in intervention and 130 in control groups. Recruitment Centre at University Hospitals Bristol NHS ended June 2013. 12-month follow up: 64%. At 12-month follow up greater improvement in Foundation Trust and the University of Bristol. mental health of women in the intervention group. Difference in average CORE-OM score Authors on the programme grant application: GeF, TJP, SH, RAD, DS. Domestic Violence Training Ltd between intervention and control groups: -3.3 points (95% CI -5.5 to -1.2). Difference in provided support in the form of salary to author average PHQ-9 score between intervention and control group: -2.2 (95% CI -4.1 to -0.3). At AD. The specific role of this author is articulated in 12 months, 35% of the intervention group and 55% of the control group were above the the ’author contributions’ section. Authors on the CORE-OM -2clinical threshold (OR 0.32, 95% CI 0.16 to 0.64); 29% of the intervention programme grant application: GeF, TJP, SH, RAD, DS. The views expressed in this publication are group and 46% of the control group were above the PHQ-9 clinical threshold (OR 0.41, 95% those of the authors and not necessarily those of CI 0.21 to 0.81), the National Health Service, the National Institute of Health Research, or the Department of Health and Social Care. The funder had no involvement in Limitations study design, data collection and analysis, decision 64% retention at 12 months to publish, or preparation of the manuscript. Authors on the programme grant application: GeF, TJP, SH, RAD, DS. Domestic Violence Training Ltd Conclusions provided support in the form of salary to author An eight-session psychological intervention delivered by DVA advocates produced clinically AD. The specific role of this author is articulated in relevant improvement in mental health outcomes compared with normal advocacy care. the ’author contributions’ section. The views expressed in this publication are those of the authors and not necessarily those of the National Trial registration Health Service, the NIHR, or the Department of ISRCTN registry ISRCTN58561170 Health. The funders had no role in study design, data collection and analysis, decision to publish, or Original Research preparation of the manuscript. Authors on the 3675/3750 programme grant application: GeF, TJP, SH, RAD, DS. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. The funder had no involvement in study design, conduct or analysis. Introduction Competing interests: The authors of this Domestic violence and abuse (DVA) is a common violation of human rights that damages manuscript have the following competing interests: physical and mental health. DVA can be physical, sexual, psychological and economic, perpe- If the PATH intervention was implemented in trated by a partner, ex-partner or adult family member. Intimate partner violence (IPV) is a service settings, Davies would receive payment for type of DVA. Although DVA is experienced by women and men, the majority of severe, training and supervising specialist psychological advocates. Domestic Violence Training Ltd repeated and sexual assaults are on women [1]. Most DVA epidemiological research has provided support in the form of salary to author focused on the impact of intimate partner violence (IPV), a major contributor to the global AD. burden of disease for women of reproductive age [2]. The main long term association of IPV is mental illness, with a three-fold risk of depressive disorders, four-fold risk of anxiety disorders and a seven-fold risk of post-traumatic stress disorder (PTSD) [3]. A meta-analysis of longitu- dinal studies has established a causal relationship between IPV and depression and suicide attempts [4]. Psychological interventions, such as counselling and cognitive behavioural therapy (CBT) that are not adapted to the specific needs of DVA survivors often fail to meet their needs [5]. Psychological interventions may not directly address the violence, and couple or family ther- apy, in which victim and perpetrator are treated together, are potentially dangerous. Survivors of DVA have found it unhelpful when interventions do not recognise trauma, make the abuser invisible by focusing exclusively on the mental health of the victim, (implicitly or explicitly) PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 2 / 17 PATH trial for domestic violence survivors blame the victim for the abuse or her reaction, offer medication rather than counselling and when a psychiatric diagnosis negatively impacts on care or child contact proceedings [6]. In contrast, women identify that interventions can be helpful when they are directly asked about their experiences of DVA, encouraged to name the abuse, helped with safety planning or par- enting and offered support to recover from their experiences [7]. There is uncertainty about the effectiveness of psychological interventions designed for sur- vivors of DVA delivered by counsellors or psychotherapists. The systematic review [8] under- pinning the 2014 UK National Institute for Health and Care Excellence (NICE) guidelines [9] found two randomized controlled trials of brief psychological interventions for IPV survivors in a refuge and for pregnant women respectively. The former [10], CBT-based, reported improvement in PTSD symptoms; the latter [11], psychotherapy-based, did not. The NICE review also reported four other randomized controlled trials testing cognitive processing, CBT and group therapy, reporting improvement in PTSD and depressive symptoms, but only one study compared the intervention group with a control group with no psychological interven- tion. Two trials by Kubany and colleagues [12, 13] not included in that review reported reduced post-traumatic stress symptoms following an individual cognitive therapy based inter- vention in DVA survivors who were no longer in abusive relationships. However, the results from those studies cannot be extrapolated to women suffering from other mental health condi- tions nor to women still subject to abuse. The World Health Organisation intimate partner violence and sexual violence guidelines [14] recommend trials with sufficient statistical power to assess the effectiveness of different models of psychological intervention/therapy for women survivors of intimate partner violence in a variety of settings. The NICE DVA guidelines [9] recommend research on the effectiveness of psychological interventions modified for domestic violence and abuse in the short, medium and long term, across various levels of risk and including diverse and marginalised groups and programmes for those who have suffered mul- tiple forms of abuse and those who are still experiencing it. In the United States, with the advent of universal screening for IPV in health care settings, there is a renewed emphasis on effective interventions for women disclosing abuse. In the United Kingdom, domestic violence advocacy or support is provided by a network of specialist DVA services, most affiliated to the Women’s Aid Federation (http://www. womensaid.org.uk/). Advocates engage with individual clients who are being or have been abused, aiming to increase their safety, empower them and link them to community services. The core activities of advocacy are provision of legal, housing and financial advice, facilitating access to and use of community resources such as refuges or shelters, emergency housing, pro- vision of safety planning advice, and ongoing support. The duration and intensity of advocacy varies within and between agencies. Generally advocates do not have a background or training in psychological therapies and do not provide counselling or other therapies. While advocacy may reduce recurrence of violence, its effect on mental health or quality of life is uncertain [15]. Given the contact that advocates have with women who have recently experienced DVA and their understanding of the context of abuse, they are a potential source of psychological support to survivors who seek help from the DVA agencies. Agnew-Davies and colleagues developed a specific intervention for this population delivered by DVA advocates given addi- tional training. The Psychological Advocacy Towards Healing (PATH) intervention is based on concepts and technical strategies drawn from cognitive-behavioural, experiential, dynamic, psycho-educational and feminist theories [16]. This model was evaluated in a before-and-after pilot with a sample of 106 women within refuge (shelter) settings, showing a reduction in par- ticipants’ psychological distress [17]. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 3 / 17 PATH trial for domestic violence survivors In this paper we report a trial of the PATH intervention in DVA service settings for women in refuges or community-based programmes, testing its clinical effectiveness in terms of men- tal health outcomes. Methods Ethics and governance The PATH trial was approved by the South West 4 (Southmead) Research Ethics Committee, part of the National Research Ethics Service, and site-specific approvals were received from that committee and the South Wales Research Ethics Committee. The conduct of the trial was overseen by an independent Trial Steering Committee (TSC), and an independent Data Moni- toring and Ethics Committee (DMEC) that reviewed safety and outcome data throughout the trial. Trial Registration: ISRCTN58561170 (http://www.isrctn.com/ISRCTN58561170). The application for trial registration was submitted to ISRCTN registry on 23.02.2011. Registration was delayed because ISRCTN suggested a fee waiver for National Institute for Health Research funded studies that are adopted into the NIHR portfolio. The adoption process was unexpect- edly lengthy and delayed the finalisation of ISRCTN registration, confirmed on 26 July 2011. Study design and participants This is an open, pragmatic or effectiveness (conducted in “real world” circumstances), two par- allel group individually randomized controlled trial. The research team, including the statisti- cians who analysed the outcomes (GFer and TJP), were blind to group assignment. Group assignment was kept in a randomisation database, separate from the analysis database. The randomisation database was only accessible to the trial data manager. The trial manager gener- ated and shared proxy participant IDs and group labels for analysis, and only revealed IDs and random assignment following completion of the analysis, during a meeting between research- ers and DVA agencies when results were first announced. Women seeking help from specialist DVA agencies were randomized with a 1:1 ratio to usual DVA agency support (advocacy alone) or usual DVA agency support plus a psychological intervention from an advocate or support worker with additional training: a specialist psychological advocate (SPA). Partici- pants were enrolled in the study for one year, during which time they had access to usual sup- port from the DVA agency. Eligible participants were women aged 16 years or older experiencing DVA which had led them to seek help from one of the recruiting sites. Exclusion criteria: having a psychotic illness, severe drug or alcohol problem; being unable to read English; currently attending counselling, cognitive behaviour therapy or other psychological treatments. Recruitment took place at two DVA agencies in England and Wales, respectively: Bristol Next Link (http://www.nextlinkhousing.co.uk/) and Cardiff Women’s Aid (http://www. cardiffwomensaid.org.uk/). All women who presented to these agencies were assessed for eligi- bility by the intake worker and invited to consider participation. A woman potentially inter- ested in participating was referred to a researcher who met with her at a safe location. Informed consent was obtained from the woman in writing if she agreed to participate. After consenting her to the study, the researcher and participant agreed an individualised contact sheet with safety information and details of locators: friends, family or associates who would be able to help the researcher contact the woman. The participant was then asked to complete a booklet of baseline questions. On completion, the participant was randomized to either receiving the PATH intervention or to the control group through a remote independent auto- mated telephone randomisation service provided by the Bristol Randomised Trials Collabora- tion (http://www.bristol.ac.uk/social-community-medicine/centres/brtc/). Randomisation was PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 4 / 17 PATH trial for domestic violence survivors stratified by urban area and whether women received support from the refuge/safe house or community based teams in the agencies. Allocation was concealed from the researcher until the moment of randomisation. Over the course of the study women were asked to self-complete three further question- naire booklets four, eight and twelve months post-randomisation. Questionnaires were either hand-delivered or sent in the post. Participants were given shopping vouchers for question- naire completion. Researchers made contact with participants at two, six and ten months post- randomization. Women were reminded either by text, telephone, or post to return question- naires at two, four and six weeks after questionnaire postal dispatch or hand-delivery. If researchers failed to contact a woman on four consecutive occasions, or the questionnaire was not returned by week seven, the researcher used the women’s locator contacts. Researchers continued to prompt women (or their locators) for the return of questionnaire until week twelve, after which the questionnaire was classified as missing. We issued the next question- naire in the series even when the previous questionnaire(s) was not returned. Returned ques- tionnaires were checked for completeness and entered into the database. Intervention and comparator Specialist psychological advocacy (SPA). Specialist psychological advocates (SPAs) received a 25-day manualised training programme (available from authors) developed by Agnew-Davies. The training addressed the psychological impacts of DVA on women and developed therapeutic skills specifically tailored for this client group. SPAs were trained to work with common presenting problems within a single session model [18], using a session structure based on the work of Daldrup and colleagues [19]. Topics included post- traumatic stress, depression, anxiety, low self-esteem, unresolved anger and managing loss. SPAs were also provided with handouts and self-help resources that could be used with their clients. Supervision was provided by Agnew-Davies, who listened to a sample of recorded SPA sessions and provided feedback through regular telephone or email contact and monthly face-to-face meetings. Participants in the intervention arm were assigned a SPA with the aim of receiving eight 1:1 SPA sessions (of one hour duration) that alter- nated with regular advocacy sessions, meeting either weekly or fortnightly with a further two ‘booster’ sessions, one and three months later. During SPA sessions the advocates used a variety of primarily cognitive behavioural psychological techniques focusing within any one session on a specific presenting problem, such as hyper-arousal, sleep difficulties or parenting problems. The SPA aimed to empower the participant to apply therapeutic strategies such as relaxation, challenging thoughts or goal setting, to promote recovery from each problem. In addition to the SPA sessions, women in the intervention group received usual care from their advocate. Usual care. Participants in the advocacy alone group had access to the usual DVA agency support and advocacy, including safety planning, assistance with health and social issues housing problems, budgeting and debt, and legal proceedings. They did not receive SPA sessions and their advocate did not receive specialist training in psychological meth- ods. The length of time a woman was engaged with a DVA agency varied depending on their needs and the service’s policies. The intensity and duration of advocacy support varied. Primary outcomes Clinical Outcomes in Routine Evaluation–Outcome Measure [20] (CORE-OM): 34 questions measuring global psychological distress, with sensitivity to change, good test-retest reliability PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 5 / 17 PATH trial for domestic violence survivors and UK normative data. It was designed to assess efficacy and effectiveness across multiple dis- ciplines offering psychological therapies [21]. We used it as a continuous measure (mean score) and as a dichotomous measure (clinical cut-off score� 9.9) [22]. Patient Health Questionnaire [23](PHQ-9): nine question measuring symptoms of depres- sion, with sensitivity to change and extensive validation in diverse populations. We used it as a continuous measure (mean score) and as a dichotomous measure (clinical cut-off score� 10 consistent with major depression) [24]. The decision on 11 March 2011 to promote this mea- sure from a secondary to a primary outcome was taken on the recommendation of our TSC and DMEC, and was implemented before the first patient was recruited. Secondary outcomes Generalized Anxiety Disorder questionnaire [25] (GAD7): seven questions measuring symp- toms of anxiety, with sensitivity to change, and a score� 10 consistent with a clinical diagnosis of generalised anxiety disorder [26]. PTSD Symptom Scale (PSS) [27] 17 questions measuring post-traumatic stress symptoms with a score�17 consistent with a clinical diagnosis of PTSD [28]. Short form-12 [29] (SF-12): 12 item acute form quality of life measure with physical and mental health subscales. Higher SF-12 scores correspond to better health states. Composite Abuse Scale [30](CAS): 30 questions measuring recent emotional, physical, and severe abuse, as well as harassment, with good sensitivity to change and robust psychometric properties, with increased use in DVA trials [31–33]. We used the CAS to measure both IPV and non-IPV DVA. For this analysis, if a participant was exposed to both types of DVA, we used the larger item score in calculating the total CAS score at each time point. All primary and secondary outcomes were measured at 4, 8 and 12 months. Data from the PHQ-9 and CORE-OM at 4 and 8 months were treated as secondary outcomes and used for imputation in the absence of the relevant 12 month outcome, because they are clearly corre- lated with it. We assessed how much contact participants in both intervention and control groups had with their advocate (SPA or non-SPA). Serious adverse events This information was collected and recorded by self-report from the participant, either ver- bally or in the questionnaire booklet, or elicited by the DVA advocate or SPA following contact with the participant. All serious adverse events were reported to the data monitoring and ethics committee (protocol available from authors). Sample size An effect size of 0.4 to 0.5 is consistent with those detected in studies of psychological interven- tions using the CORE-OM as an outcome measure [34] and is consistent with findings for CBT interventions on PHQ-9 and other measures of depression [35]. Two hundred partici- pants gives a power of 96% to detect a difference of 0.5 on the CORE-OM (a “reliable change index” [36]), corresponding to an effect size of 0.5, and 81% power to detect an effect size of 0.4. Assuming an attrition of 20%, we aimed to recruit 250 women. Statistical analysis As specified in advance for the primary analyses at 12 months, we analysed groups as rando- mised, conducting linear regression analyses for continuous, and logistic regression analyses for binary outcomes. These models were used for primary and secondary outcomes at 12 PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 6 / 17 PATH trial for domestic violence survivors months from randomisation (labelled intention-to-treat, or ITT, here). We adjusted for site (Bristol or Cardiff) and setting (safe house/shelter or community). We did not need to adjust for imbalance in baseline scores of the characteristics of the groups. We adjusted for baseline values of the outcome variables to increase the precision of our estimates. We conducted our pre-specified subgroup analyses by site, setting and age [37], by introducing the relevant inter- action effect in our regressions models [38]. As specified in our protocol [37], we investigated whether including participants lost to follow up alters our estimates of effectiveness in sensitiv- ity analyses based on multiple imputation by chained equation models (mice) for the main model [39]. We generated 100 imputed datasets using a mice model with all outcome variables at all time-points, in addition to the variables included in the model for the main analysis (treatment arm plus stratification by urban area and setting). We did not include socio-demo- graphic variables in the mice model, because they did not predict missingness for individual variables. We calculated complier-average causal effects (CACE) using instrumental variables regression techniques to explore a causal link between assignment to treatment and impact in relation to treatment adherence (number of treatment sessions received) [40], using a mini- mum of four sessions. This analysis was specified in our protocol [37]. It supersedes the gener- alised mixed model with number of sessions as a fixed categorical effect specified in the protocol as a secondary analysis to assess stability of treatment effect [37], because an instru- mental variables-based CACE is better placed to both address and account for the issue of treatment non-adherence [41] (see S1 Text for further details). We assessed fidelity of the intervention by listening to a stratified random sample of audio- files. A fidelity scale (available from the authors) was developed to measure adherence of SPAs to the PATH model. The scale was adapted from a revised version of the Cognitive Therapy Scale (CTS-R) [42], a widely used measure of competence in CBT, and was used to rate the content of the audiotapes. We have published details of the trial design [37]. The cost-effectiveness analysis will be reported in a separate paper. Funding and conflict of interest This paper presents independent research funded by the United Kingdom National Institute for Health Research (NIHR) under its Programme Grants for Applied Research scheme (RP-PG-0108-10084). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. The funder had no involvement in study design, conduct or analysis. If the PATH intervention was implemented in service settings, Agnew-Davies would receive payment for training and super- vising SPAs. The other authors declare no conflicts of interest. Results We report on the analysis of the primary and secondary outcomes at the primary follow up point of 12 months, between the two groups of women as randomised (ITT). Trial flow and baseline characteristics Between April 2011 and May 2013 we obtained consent and randomized 263 participants: 24% of eligible women seeking help from the two participating DVA agencies (1096), 51% of women who consented to be contacted by a researcher (513), and 83% of women who met with a researcher to discuss participation (317). 64% of participants were retained for the full 12 month follow up period to the end of the trial, although we had primary outcome data from any follow up time point available for 78% of participants (78% SPA group, 77% advocacy PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 7 / 17 PATH trial for domestic violence survivors Fig 1. CONSORT diagram illustrating participants‘ flow through the various stages of the trial data collection process. https://doi.org/10.1371/journal.pone.0205485.g001 alone group). In some cases, it was impossible to establish the reason for loss to follow up, as women had also lost contact with the collaborating agencies (Fig 1). The vulnerability and mobility of women experiencing DVA makes follow up in longitudinal studies challenging [43, 44]. Women lost to follow up were more likely to have been in refuges: 42% lost to follow up, versus 23% lost to follow up among women who were not in a refuge. This would be expected, because women who leave their home for a refuge are more likely to subsequently leave the local area. However, all other socio-demographic characteristics and outcomes did not differ between women lost to follow up and women who remained in the study (S1 Table). In addi- tion, in terms of socio-demographic characteristics or outcomes, women lost to follow up in the control group (N = 43) were comparable to women lost to follow up in the intervention group (N = 47). The SPA group and advocacy alone group had similar characteristics at baseline (Tables 1 and 2, with more details available elsewhere[45]). Of the 120/130 participants in the SPA group for whom we have information on adherence, 54 (45%) attended fewer than four sessions, and 66 (55%) attended four or more, which we pre-specified as reflecting adequate adherence. Implementation partners also shared records PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 8 / 17 PATH trial for domestic violence survivors Table 1. Baseline characteristics of participants–socio-demographics, alcohol and substance misuse, childhood and abuse. Treatment Group Control Group Characteristics Respondents Mean (SD) Proportion of Respondents Mean (SD) Proportion of Range (min, respondents (%) Range (min, respondents (%) max) max) Age 123 33 (11) 126 34 (10) (18, 67) (18, 65) White British or other white background 106/126 (84) 113/127 (89) Who completed secondary education 96/116 (83) 97/117 (83) Whose yearly income is at least $17,710 16/69 (23) 28/87 (32) Hazardous drinking (Audit-C> = 3) 70/126 (56) 65/125 (52) Smoked cannabis in past 12 months 36/124 (29) 28/121 (23) Made use of type A drugs 11/127 (9) 9/125 (7) Currently in a relationship 26/127 (20) 25/123 (20) Is parent 97/125 (78) 109/129 (84) Has child under 4 years living with her 49/130 (38) 47/130 (36) Perpetrator is a current partner 29/118 (25) 26/118 (22) Work in the household 46/116 (40) 43/121 (36) Not in formal employment (excl retirees 90/115 (78) 93/121 (77) and students) Witnessed DVA as a child 66/129 (51) 67/128 (52) Abused as a child 65/129 (50) 64/128 (50) GBP to USD conversion rate, Nov 01 2012 (source: http://www.oanda.com/currency/converter/) Heroin (diamorphine), cocaine (including crack), methadone, ecstasy (MDMA), LSD, and magic mushrooms https://doi.org/10.1371/journal.pone.0205485.t001 of participants’ attendance at advocacy sessions for all participants. These data show that the average number of advocacy sessions was 5.8 (SD 6.6) for control group participants (N = 124), and 7.2 (SD 6.8) for SPA clients (N = 95). Fig 2 illustrates the flow of women through the intervention. More than half of the 120 for whom we have attendance records attended four or more of the sessions. One third attended all eight sessions. Thirty-five women also attended the first booster session, and 26 attended both booster sessions. Primary outcomes Table 2 shows a 3.3 point lower mean CORE-OM score and a 2.2 point lower mean PHQ-9 score between the SPA and the advocacy group at 12 months’ follow up. 35% of the SPA group and 55% of the advocacy alone group were above the clinical threshold for the CORE-OM at 12 months respectively (odds ratio 0.32, 95% confidence interval 0.2 to 0.6), with proportions at baseline of 78% and 74% respectively. 29% of the SPA group and 46% of the advocacy alone group were above the clinical threshold for the PHQ-9 at 12 months respectively (odds ratio 0.4, 95% confidence interval 0.2 to 0.8). Trends in the CORE-OM and PHQ-9 score over the 12-month period post randomisation suggest that the intervention group experiences a sharper improvement in mental health four months post recruitment, compared with the con- trol group. Both groups remain stable around the initial reductions over the intervening eight months, suggesting that intervention participants sustain the relative improvement (S1 Fig). Secondary outcomes The PTSD score is lower in the SPA than in the advocacy alone group after 12 months and the proportion of women below the clinical threshold for PTSD is also lower in the SPA group. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 9 / 17 PATH trial for domestic violence survivors Table 2. Baseline characteristics of participants–domestic abuse and mental health. SPA Control Characteristics Respondents Mean (SD) Proportion of Respondents Mean (SD) Proportion of Range (min, respondents (%) Range (min, respondents (%) max) max) Composite Abuse Scale (CAS) Total abuse (total score CAS, continuous) 129 59 (35) 129 58 (35) (0, 138) (0, 150) Total abuse (total score CAS> = 3) 124/129 (96) 124/129 (96) Severe abuse (severity CAS> = 1) 89/129 (69) 94/129 (73) Emotional abuse (emo CAS> = 3) 122/129 (95) 123/129 (95) Physical abuse (physical CAS > = 1) 119/129 (92) 117/129 (91) Harassment (harassment CAS> = 2) 113/129 (88) 109/129 (84) Abused by a family member (not intimate 41/125 (33) 42/127 (33) partner) Abused for more than 5 years (includes IPV and 28/117 (24) 41/121 (34) other domestic abuse) Past year experience of abuse (includes IPV and 105/117 (90) 112/120 (93) other domestic abuse) CORE-OM clinical 130 18 (8) 129 18 (7) (1, 35) (2, 35) PHQ-9 130 15 (8) 128 14 (7) (0, 27) (0, 27) GAD7 129 13 (6) 126 13 (6) (0, 21) (0, 21) PTSD 130 27 (12) 126 26 (11) (0, 51) (0, 51) SF12physical 113 48 (12) 123 49 (12) (21, 68) (15, 71) SF12mental 113 31 (14) 123 31 (13) (4, 67) (6, 62) Note: ‘SPA’ refers to women randomly selected to attend the specialist psychological advocacy treatment. ‘Control’ refers to women randomised to the usual care advocacy group. https://doi.org/10.1371/journal.pone.0205485.t002 Fig 2. Minimum number of SPA sessions attended. Bars show the number of treated clients attending none, or at least the stated number of sessions. https://doi.org/10.1371/journal.pone.0205485.g002 PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 10 / 17 PATH trial for domestic violence survivors Table 3. Differences in primary outcomes at 12 months. Variable SPA Control Beta Variable SPA Control aOR mean (sd) mean (sd) (95% CI) (n /N ) (n /N ) 1 1 2 2 Continuous Measures Binary Measures Primary Outcomes CORE-OM clinical 11.3 (8.6) 14.2 (7.9) -3.3 CORE-OM caseness 30/84 46/83 0.32 (-5.5, -1.2) (0.16, 0.64) p value 0.003 p value 0.001 N 84 83 166 N 166 PHQ-9 7.1 (7.0) 8.9 (6.4) -2.2 PHQ-9> = 10 24/83 38/83 0.41 (-4.1, -0.3) (0.21, 0.81) p value 0.021 p value 0.010 N 83 83 165 N 165 Secondary Outcomes Measures of Mental Health PTSD 15.5 (12.9) 18.9 (12.6) -3.9 PTSD> = 17 36/87 47/83 0.50 (-7.3, -0.52) (.25, .99) p value 0.024 p value 0.047 N 87 83 168 N 168 GAD7 6.2 (6.1) 7.4 (5.7) -1.4 GAD7> = 10 24/83 24/83 0.95 (-3.1, 0.36) (0.47, 1.9) p value 0.12 p value 0.88 N 83 83 163 N 163 Measures of Health State SF12 40.5 (15.6) 36.2 (14.0) 4.6 Mental (0.050, 9.2) p value 0.048 N 82 81 150 SF12 47.4 (11.0) 48.5 (12.1) -0.41 Physical (-3.42, 2.6) P value 0.79 N 82 81 150 Measure of Abuse (IPV or non-IPV) Domestic abuse 16.5 (28.9) 21.9 (29.7) -5.1 Abuse cases 37/81 49/82 0.56 (-13.9, 3.7) (0.30, 1.05) p value 0.251 p value 0.071 N 161 N 161 Note: beta is the coefficient on the treatment (SPA) variable in the linear regression models for continuous outcomes; aOR are adjusted odds-ratios from the logistic regressions for binary outcomes. ‘SPA’ refers to women randomly selected to attend the specialist psychological advocacy treatment. ‘Control’ refers to women randomised to the usual care advocacy group. Estimates are adjusted for site (Bristol or Cardiff) and setting (safe house/shelter or community), as well as baseline values of the relevant outcome variable. https://doi.org/10.1371/journal.pone.0205485.t003 However, there was no evidence of a difference in GAD-7 score nor the proportion of women below the clinical threshold (Table 3). The SF-12 mental health score is higher in the SPA group, and there is no evidence for a difference in the SF-12 physical health score. There is no evidence of a difference in total exposure to further abuse. Pre-specified secondary analyses For primary and secondary outcomes, the multiple imputation for missing data gave lower point estimates for differences between intervention and control groups, although all were PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 11 / 17 PATH trial for domestic violence survivors within the 95% confidence intervals of the complete case analysis (S2 Table). The imputations for binary outcomes yielded very similar odds ratios to the complete case analysis (S2 Table). The CACE analysis results in roughly a doubling of the effect of the intervention across mental health and abuse variables, consistent with greater benefit for those participants attending a sufficient number of SPA sessions (S2 Table). The fidelity analysis (details available from the authors) shows that SPAs broadly adhered to the session structure and the working alliance with participants, as specified in the PATH manual and training. The subgroup analyses found no evidence of interaction effects between treatment and age, site and setting (S3 Table). Serious adverse events 22 women (15 in the SPA group, seven in the advocacy alone group) reported a total of 32 seri- ous adverse events (Table 4). For three women (four events) in the intervention group, it was unclear from the information available whether the SAEs were related to trial participation. These events were reported to the NHS research ethic committee (REC) that had approved the study, following advice from the chair of our study’s independent Data Monitoring & Ethics Committee. The REC judged that nochanges to the conduct of the intervention or trial were necessary. None of the remaining 28 SAEs (19 women) were related to trial participation. Most of the serious adverse events were hospital admission due to physical or mental ill health. This included six cases of attempted suicide, seven cases related to pregnancy or miscarriage, three cases of injuries from physical assault, ten cases of chest or abdominal pain and two planned admissions. Planned admissions and injuries from physical assault were only found in the intervention arm. All other non-miscellaneous categories occurred with a similar fre- quency in both arms. Conclusions This study is the first randomized controlled trial of an intervention to improve mental health symptoms of women experiencing DVA delivered by advocates with additional training in psychological methods. The PATH intervention, unlike the majority of psychological treat- ments for survivors of DVA, which are delivered by psychologists or counsellors, is based on a relatively brief training of advocates already in the DVA sector with ongoing supervision by a psychologist. Table 4. Serious adverse events by randomisation arm. SAE type Random assignment SPA (N) Control (N) Attempted suicide 4 2 Planned 2 0 Pregnancy-related 5 2 Injuries from physical assault 3 0 Chest/abdominal pain 7 3 Other 2 2 Total 23 9 Note: ‘SPA’ refers to women randomly selected to attend the specialist psychological advocacy treatment. ‘Control’ refers to women randomised to the usual care advocacy group. https://doi.org/10.1371/journal.pone.0205485.t004 PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 12 / 17 PATH trial for domestic violence survivors We found that the primary outcomes of psychological distress and symptoms of depression were reduced in both arms compared to baseline, with evidence of a difference between the groups at 12 months follow up. This was also the case for post-traumatic stress symptoms and a general measure of mental health state (SF-12mental), but not anxiety or experience of fur- ther abuse. Although the differences in mean scores for the primary outcomes between the groups are relatively modest, there are clinically important differences in the primary outcomes expressed as proportions of participants in the intervention and control groups with depression and with psychological distress. The treatment effect is reduced with imputation for missing data and increased in those participants attending more SPA sessions. A judgement about whether the extent of benefit justifies implementation of the PATH intervention needs to take into account the findings of the nested qualitative study, reported in the accompanying qualitative paper (see Evans et al., DOI: 10.1371/journal.pone.0193077), that explores the experiences of participants. The four SAEs in which the relation to trial participation was uncertain occurred in the control group. The greater number of SAEs over all recorded in the intervention group was probably due to greater contact with DVA advocates. Strengths and limitations Strengths of PATH include: recruitment of a sizeable proportion of the eligible women experiencing abuse and seeking help [46]; successful collaboration with agencies in the DVA sector to deliver a psychological intervention with reasonable fidelity; relatively complete data collection from participants retained in the trial; outcome data from at least one time point after randomisation from 74% of participants; and a nested longitudinal qualitative study (see Evans et al., DOI: 10.1371/journal.pone.0193077). The main limitation threatening the internal validity of the trial is the 34% loss of participants 12 months post-intervention, requiring pre- specified imputation of the missing outcome data. The main limitation threatening its external validity is the proportion of eligible women who did not participate, including those who wanted counselling and potentially most likely to respond to the intervention. Finally, this was a “real world” pragmatic trial, where intervention participants had higher levels of contact with services because they accessed SPA treatment in addition to usual care. The absence of an attention control group means we cannot exclude the possibility that the additional contact was responsible for the treatment effect. However, our IV results in conjunction with advo- cates’ adherence to the treatment model (see fidelity analysis) provides support for the hypoth- esis that the increased effectiveness deriving from attendance may be explained by the treatment, rather than more exposure to advocates. Comparison with other studies The standardised effect size of the SPA intervention (0.4 for CORE-OM and 0.32 for PHQ-9) is similar to the effect of psychological treatment for depression in primary care [47]. The effect on mental health outcomes is comparable to other trials of psychological interventions for sur- vivors of DVA measuring treatment impact on trauma-related mental health symptoms or wellbeing, as systematically reviewed by Warshaw and colleagues [48]. Five of the nine studies in that review were CBT-based interventions for women who were experiencing IPV and three were targeted at women with additional conditions: suicidality, substance abuse or preg- nancy. All the interventions were delivered by trained therapists, whereas the PATH interven- tion was delivered by domestic violence advocates with relatively brief training, but ongoing supervision. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 13 / 17 PATH trial for domestic violence survivors Implications of findings The PATH intervention delivered by specialist psychological advocates can improve psycho- logical distress and depressive symptoms in women survivors of DVA, the majority of whom had experienced IPV. The findings of the trial and of the nested qualitative study (see Evans et al., DOI: 10.1371/journal.pone.0193077) show heterogeneity in response to the intervention; further abuse, experienced by a large minority of participants, possibly attenuated its effect. These findings from a pragmatic trial can be implemented in DVA agency settings that already employ advocates, if they undergo further training. Supporting information S1 Table. Participants successfully followed up at 12 months vs participants who were not, baseline characteristics. (DOCX) S2 Table. Complete case analysis compared with mice and CACE estimates. (DOCX) S3 Table. Subgroup analyses. (DOCX) S4 Table. CONSORT checklist PATH. (DOC) S1 Fig. Main outcomes, time trends. (DOCX) S1 Text. Methodological discussion of the instrumental variables estimates for PATH. (DOCX) S2 Text. Trial of an individually randomised, parallel group controlled trial to determine if a psychological intervention delivered by domestic violence advocates is effective and cost-effective: Psychological Advocacy Towards Healing (PATH). (DOC) S3 Text. PATH protocol paper (Trials 2013). (PDF) Acknowledgments Thank you to: Gwen Brierley, first trial manager of PATH; David Carmichael, database man- ager; Carol Metters and her colleagues at Next Link; Morgan Fackrell and her colleagues at Cardiff Womens Aid. Author Contributions Conceptualization: Gene Feder, Roxane Agnew-Davies, Sandra Hollinghurst, Louise Howard, Debbie Sharp, Tim J. Peters. Data curation: Giulia Ferrari. Formal analysis: Giulia Ferrari. Funding acquisition: Gene Feder, Sandra Hollinghurst, Debbie Sharp, Tim J. Peters. Investigation: Jayne E. Bailey, Emma Howarth, Lynnmarie Sardinha. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 14 / 17 PATH trial for domestic violence survivors Methodology: Giulia Ferrari, Gene Feder, Roxane Agnew-Davies, Sandra Hollinghurst, Louise Howard, Emma Howarth, Lynnmarie Sardinha, Debbie Sharp, Tim J. Peters. Project administration: Gene Feder, Jayne E. Bailey. Supervision: Gene Feder, Roxane Agnew-Davies, Jayne E. Bailey, Sandra Hollinghurst, Louise Howard, Tim J. Peters. Visualization: Giulia Ferrari. Writing – original draft: Giulia Ferrari, Gene Feder. Writing – review & editing: Giulia Ferrari, Gene Feder, Roxane Agnew-Davies, Jayne E. Bai- ley, Sandra Hollinghurst, Louise Howard, Emma Howarth, Lynnmarie Sardinha, Debbie Sharp, Tim J. Peters. References 1. Breiding MJ, Smith SG, Basile KC, Walters ML, Chen J, MT. M. Prevalence and characteristics of sex- ual violence, stalking, and intimate partner violence victimization—national intimate partner and sexual violence survey, United States, 2011. MMWR Surveill Summ. 2014; 63(8):1–18. PMID: 25188037 2. WHO. Global and regional estimates of violence against women: prevalence and health effects of inti- mate partner violence and non-partner sexual violence. Geneva: WHO; 2013. 3. Trevillion K, Oram S, Feder G, Howard LM. Experiences of Domestic Violence and Mental Disorders: A Systematic Review and Meta-Analysis. PLoS ONE. 2012; 7(12):e51740. https://doi.org/10.1371/ journal.pone.0051740 PMID: 23300562 4. Devries KM, Mak JYT, Garcı ´a-Moreno C, Petzold M, Child JC, Falder G, et al. The Global Prevalence of Intimate Partner Violence Against Women. Science. 2013; 340(6140):1527–8. https://doi.org/10. 1126/science.1240937 PMID: 23788730 5. Ramsay J, Feder G, Rivas C. Interventions to reduce violence and promote the physical and psychoso- cial well-being of women who experience partner abuse: a systematic review. In: Health Do, editor. London2006. 6. Trevillion K, Howard LM, Morgan C, Feder G, Woodall A, Rose D. The Response of Mental Health Ser- vices to Domestic Violence: A Qualitative Study of Service Users’ and Professionals’ Experiences. Jour- nal of the American Psychiatric Nurses Association. 2012; 18(6):326–36. https://doi.org/10.1177/ 1078390312459747 PMID: 22989418 7. Humphreys C, Thiara R. Mental Health and Domestic Violence: ’I Call it Symptoms of Abuse’. British Journal of Social Work. 2003; 33(2):209–26. 8. British Columbia Centre of Excellence for Women’s Health. Review of Interventions to Identify, Prevent, Reduce and Respond to Domestic Violence2013 9th February 2016. Available from: https://www.nice. org.uk/guidance/ph50/resources/review-of-interventions-to-identify-prevent-reduce-and-respond-to- domestic-violence2). 9. (NICE) NIfHaCE. Domestic violence and abuse: how health services, social care and the organisations they work with can respond effectively.; 2014. 10. Johnson DM, Zlotnick C, Perez S. Cognitive behavioural treatment of PTSD in residents of battered women’s shelters: results of a randomized clinical trial. J Consult Clin Psychol. 2011; 79(4):542–51. https://doi.org/10.1037/a0023822 PMID: 21787052 11. Zlotnick C, Capezza NM, Parker D. An interpersonally based intervention for low-income pregnant women with intimate partner violence: a pilot study. Archives of Womens Mental Health. 2011; 14 (1):55–65. 12. Kubany ES, Hill EE, Owens JA. Cognitive trauma therapy for battered women with PTSD: preliminary findings. J Trauma Stress. 2003; 16(1):81–91. https://doi.org/10.1023/A:1022019629803 PMID: 13. Kubany ES, Hill EE, Owens JA, Iannce-Spencer C, McCaig MA, Tremayne KJ, et al. Cognitive trauma therapy for battered women with PTSD (CTT-BW). J Consult Clin Psychol. 2004; 72(1):3–18. https:// doi.org/10.1037/0022-006X.72.1.3 PMID: 14756610 14. WHO. Responding to intimate partner violence and sexual violence against women: WHO clinical and policy guidelines. Geneva: WHO; 2013. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 15 / 17 PATH trial for domestic violence survivors 15. Rivas C, Ramsay J, Sadowski L, Davidson LL, Dunne D, Eldridge S, et al. Advocacy interventions to reduce or eliminate violence and promote the physical and psychosocial well-being of women who experience intimate partner violence. Cambell Systematic Reviews. 2016; 2. 16. Agnew-Davies R. Reframing psychological symptoms in the context of domestic violence. 37th Annual Meeting Society for Psychotherapy; June 2006; Edinburgh UK2006. 17. Rees A, Agnew-Davies R, Barkham M, editors. Outcomes for women escaping domestic violence. Society for Psychotherapy Research: From research to practice; 2006. 18. Hoyt MF. Some stories are better than others. 2000 2000. 19. Daldrup R, Greenberg L, Beutler L, Engle D. Focused expressive psychotherapy: Freeing the overcon- trolled patient. London: Guildford Press; 1988. 20. Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, et al. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002; 180:51–60. PMID: 11772852 21. Barkham M, Mellor-Clark J, Connell J, J C. A core approach to practice-based evidence: a brief history of the origins and applications of the CORE-OM and CORE System. Couns Psychother Res 2006; 6:3– 22. Connell J, Barkham M, Stiles WB, Twigg E, Singleton N, Evans O, et al. Distribution of CORE-OM scores in a general population, clinical cut-off points and comparison with the CIS-R. Br J Psychiatry. 2007; 190:69–74.:69–74. https://doi.org/10.1192/bjp.bp.105.017657 PMID: 17197659 23. Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic and severity measure. Psychiat Ann. 2002; 32(9):509–15. 24. Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. Can Med Assoc J. 2012; 184(3):E191–E6. 25. Spitzer RL, Kroenke K, Williams JBW, Lowe B. A brief measure for assessing generalized anxiety disor- der—The GAD-7. Arch Intern Med. 2006; 166(10):1092–7. https://doi.org/10.1001/archinte.166.10. 1092 PMID: 16717171 26. Kertz S, Bigda-Peyton J, T B. Validity of the Generalized Anxiety Disorder-7 scale in an acute psychiat- ric sample. Clin Psychol Psychother. 2013; Sep-Oct( 20(5)):456–64. https://doi.org/10.1002/cpp.1802 PMID: 22593009 27. Foa EB, Riggs DS, Dancu CV, Rothbaum BO. Reliability and validity of a brief instrument for assessing post-traumatic stress disorder. Journal of Traumatic Stress. 1993; 6:459–73. 28. Griffing S, Lewis CS, Chu M, Sage RE, Madry L, Primm BJ. Exposure to Interpersonal Violence as a Predictor of PTSD Symptomatology in Domestic Violence Survivors Journal of Interpersonal Violence 2006; 21. 29. Ware JE, Kosinski M, Turner-Bowker DM, Gandek B. User’s Manual for the SF-12v2® Health Survey (With a Supplement Documenting SF-12® Health Survey). Lincoln, Rhode Island: QualityMetric Incor- porated 2002. 30. Hegarty K, Fracgp, Bush R, Sheehan M. The composite abuse scale: further development and assess- ment of reliability and validity of a multidimensional partner abuse measure in clinical settings. Violence Vict. 2005; 20(5):529–47. PMID: 16248489 31. MacMillan HL, Wathen CN, Jamieson E, Boyle MH, Shannon HS, Ford-Gilboe M, et al. Screening for intimate partner violence in health care settings: a randomized trial. JAMA. 2009; 302(5):493–501. https://doi.org/10.1001/jama.2009.1089 PMID: 19654384 32. Taft A, O’Doherty L, Hegarty K, Ramsay J, Davidson L, Feder G. Screening women for intimate partner violence in healthcare settings. CochraneDatabaseSystRev. 2013; 4:CD007007. https://doi.org/10. 1002/14651858.CD007007.pub2.:CD007007 PMID: 23633338 33. Glass N, Clough A, Case J, Hanson G, Barnes-Hoyt J, Waterbury A, et al. A safety app to respond to dating violence for college women and their friends: the MyPlan study randomized controlled trial proto- col. Bmc Public Health. 2015; 15:871. https://doi.org/10.1186/s12889-015-2191-6 PMID: 26350482 34. Barkham M, Stiles WB, Connell J, Twigg E, Leach C, Lucock M, et al. Effects of psychological therapies in randomized trials and practice-based studies. BrJClinPsychol. 2008; 47(Pt 4):397–415. 35. Butler A, Chapman J, Forman E, Beck A. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006; 26:17–31. https://doi.org/10.1016/j.cpr.2005.07.003 PMID: 36. Barkham M, Mellor-Clark J, Connell J, Cahill J. A core approach to practice-based evidence: A brief his- tory of the origins and applications of the COREOM and CORE System. Counselling and Psychother- apy Research. 2006; 6(1):3–15. PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 16 / 17 PATH trial for domestic violence survivors 37. Brierley G, Agnew-Davies R, Bailey J, Evans M, Fackrell M, Ferrari G, et al. Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial. Trials. 2013; 14(1):221. 38. Sun X BM, Busse JW, You JJ, Akl EA, Mejza F, Bala MM, et al. Credibility of claims of subgroup effects in randomised controlled trials: systematic review. British Medical Journal. 2012; 344:e1553. https://doi. org/10.1136/bmj.e1553 PMID: 22422832 39. Spratt M CJ, Sterne JA, Carlin JB, Heron J, Henderson J, Tilling K Strategies for multiple imputation in longitudinal studies. Am J Epidemiol. 2010; 172:478–87. https://doi.org/10.1093/aje/kwq137 PMID: 40. Greenland S. An introduction to instrumental variables for epidemiologists. International journal of epi- demiology. 2000; 29(4):722–9. PMID: 10922351 41. Hernan MA, Robins JM. Instruments for causal inference: an epidemiologist’s dream? Epidemiology (Cambridge, Mass). 2006; 17(4):360–72. 42. Blackburn IM, James IA, Milne DL, Baker C, Standart S, Garland A, et al. The revised cognitive therapy scale (CTS-R): psychometric properties. Behavioural and Cognitive Psychotherapy. 2001; 29(4):431– 43. Schrager J, Smith L, Heron S, Houry D. Does stage of change predict improved intimate partner vio- lence outcomes following an emergency department intervention? Acad Emerg Med. 2013 20(2):169– 77. https://doi.org/10.1111/acem.12081 PMID: 23406076 44. Houry D, Feldhaus K, Peery B, Abbott J, Lowenstein SR, Al-Bataa-De-Montero S, et al. A positive domestic violence screen predicts future domestic violence. Journal of Interpersonal Violence. 2004; 19 (9):955–66. https://doi.org/10.1177/0886260504267999 PMID: 15296611 45. Ferrari G, Agnew-Davies R, Bailey J, Howard L, Howarth E, Peters TJ, et al. Domestic violence and mental health: a cross-sectional survey of women seeking help from domestic violence support ser- vices. Global Health Action. 2016; 9(29890). 46. McGarry J, Ali P. Researching domestic violence and abuse in healthcare settings: Challenges and issues. Journal of Research in Nursing. 2016; 21(5–6):465–76. 47. Cuijpers P, van Straten A, van Schaik A, Andersson G. Psychological treatment of depression in pri- mary care: a meta-analysis. British journal of general practice. 2009;February:E51–E60. https://doi.org/ 10.3399/bjgp09X395139 PMID: 19192368 48. Warshaw C, Sullivan C, Riviera EA. Systematic Review of Trauma-Focused Interventions for Domestic Violence Survivors Washington DC: National Center on Domestic Violence, Trauma & Mental Health; PLOS ONE | https://doi.org/10.1371/journal.pone.0205485 November 27, 2018 17 / 17

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