Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial

Intimate partner violence (IPV) refers to behaviour by a partner or ex-partner that causes (or has the potential to cause) physical, sexual or psychological harm. IPV includes physical aggression, sexual coercion, psychological abuse and controlling activity [1]. It is highly prevalent worldwide [2] and an important social determinant of physical and mental health [3, 4]. In response, the World Health Organization (WHO) [5], the United Nations [6] and the World Psychiatric Association [7‐9] have prioritised interventions to prevent and address IPV and its health impacts.

The relationship between IPV and mental health is bidirectional, such that IPV increases a woman’s risk of mental disorders, which in turn increases a woman’s vulnerability to (further) IPV. For example, IPV is associated with subsequent depressive symptoms, suicide attempts [10] and alcohol use disorders [11], which increase women’s risk for IPV (re)victimisation. Exposure to IPV is rarely assessed in randomised controlled trials (RCTs) of psychological interventions [12], but some studies have found reduced IPV alongside improved mental health [13] and birth outcomes [14].

There is limited evidence on mental health interventions tailored to the needs of pregnant women experiencing IPV [15], especially in low- and middle-income countries (LMICs). In a rapid review of evidence, 33 studies were identified that reported mental health interventions for women affected by IPV [16]. In most of these studies, the interventions were group-delivered cognitive behavioural therapy (CBT)-informed interventions, mind–body interventions (such as mindfulness-based stress reduction, yogic techniques and biofeedback) or individually delivered, trauma-focused psychotherapeutic interventions. Although all the identified studies came from high-income countries, protocols from Tanzania [17] and South Africa [18] indicated growing research interest in the African region. For example, one RCT in Nairobi, Kenya, has shown that five sessions of the multicomponent behavioural treatment Problem Management Plus (PM+) delivered to women with a history of any gender-based violence are associated with improved psychological distress and post-traumatic stress symptoms at 3-month follow-up compared with enhanced usual care [19].

A recent systematic review confirmed the paucity of intervention research addressing the mental health of both survivors and perpetrators of IPV in LMICs [20]; no studies replicated evaluations of previously studied interventions and none were conducted in low-income countries. The authors recommended strengthening the theoretical underpinnings of mental health interventions for people experiencing or perpetrating IPV, testing their impacts on hypothesised mediators and improving IPV detection using continuous outcome measures and fully powered samples. Treating depression and post-traumatic stress disorder (PTSD) has the potential to reduce self-blame, low self-esteem, hopelessness and emotional numbing, and improve communication, stress coping and anger management skills among both survivors and perpetrators [20].

We recently investigated whether IPV exposure moderates the efficacy of generic psychological interventions in LMICs. Our meta-analysis of 15 studies that provided data showed that women reporting IPV demonstrated greater improvements in anxiety symptoms than women not reporting IPV following generic psychological interventions (difference in standardised mean differences, 0.31; 95% confidence interval 0.04–0.57; I² 49.3%) and consistent but non-significant differences in PTSD, depression and psychological distress symptom improvements [21]. Our systematic review only identified two RCTs of psychological interventions for depression or anxiety in LMICs which were tailored for women experiencing IPV. In Pakistan, ten sessions of IPV-adapted group CBT were associated with improved depression and anxiety compared with CBT-based self-help groups [22]. In Iran, 10–12 sessions of IPV-tailored narrative exposure therapy were associated with improved PTSD and depression at 3- and 6-month follow-up compared with treatment as usual (life skills training and supportive counselling) [23]. These studies support the potential benefits of adapting psychological interventions for depression, anxiety or PTSD to meet the needs and experiences of women affected by IPV.

Although PM+ has been shown to be effective for women experiencing gender-based violence in Nairobi [19], delivering five 90-min sessions may not be feasible in primary care settings in low-income countries. Problem solving therapy (PST) is a brief psychological intervention that aims to improve coping with life problems by teaching problem solving skills. A meta-analysis of PST for depression found a standardised mean effect size of 0.34, but high heterogeneity among included studies indicated the need for research to determine the settings and patient groups for whom PST is most effective [24]. A meta-analysis of PST for any mental or physical health problem found that it was significantly more effective than no treatment, treatment as usual, and ‘attention placebo’ arms (controlling for non-specific effects of contact), moderated by the use of problem orientation training and homework assignments [25].

Several studies from LMICs suggest that PST can be effective for treating depression, anxiety and psychological distress. A 5-week pilot study of adapted PST in English, Xhosa and Afrikaans in South African township residents found that it was acceptable, feasible and associated with significant reductions in psychological distress [26]. An RCT of South African emergency department attendees found that substance use was significantly reduced at 3-month follow-up in participants who received five sessions of blended PST and motivational interviewing, compared to motivational interviewing alone or psychoeducation control [27]. In Zimbabwe, the ‘Friendship Bench’ intervention comprised six sessions of individual PST delivered by lay health workers, and an optional six-session peer support group [28]. In this 86% female sample, depression and psychological distress were significantly reduced following PST in comparison to enhanced usual care.

The importance of designing RCTs to evaluate mediators of treatment and mechanisms of change is widely supported [29]. However, despite evidence of efficacy, studies of how PST works are limited and contradictory. Hypothesised mechanisms have included improving mastery, self-control and the accuracy of perceived problem severity [30], problem solving skills [31], ‘life integration’ [32] and locus of control (the extent to which the individual attributes their experiences to internal or external factors) [33]. An RCT comparing online CBT, PST and waiting list control for depression found that the effects of both interventions were mediated by reduced dysfunctional attitudes, worry, negativity towards problems and increased mastery, with no difference in effect sizes between CBT and PST [34]. The authors postulated that both interventions increase expectations of self-efficacy, leading to greater commencement and continuation of coping behaviours [35]. Both mechanisms for improved mood might also influence the ability of women to respond to IPV.

Process evaluations of complex intervention feasibility studies are increasingly recognised as being vital to optimise the safety, efficiency and validity of subsequent RCTs [5, 36]. Updated guidance [37] and growing consensus [38] support the need for studies to determine the feasibility of research methods used to study complex interventions before conducting definitive RCTs. Sociocultural, health system and economic factors affect the adaptation, translation, mechanisms, success and scale-up of interventions, so a mixed-method process evaluation [39] is crucial and helps to inform understanding of the context for future implementation [40].

In rural Ethiopia, 72% of women are exposed to lifetime IPV [41] and this is associated with emotional distress [42] and depression [43]. IPV in Ethiopia is most prevalent during pregnancy [44] and increases the risk of child morbidity and mortality associated with maternal depression [45]. Antenatal depression in Ethiopia is associated with increased emergency presentations in pregnancy [46], perinatal complications [47], prolonged labour [48] and use of emergency delivery care [49]. As pregnancy is the most common time for Ethiopian women to access health care [50], antenatal care offers an important opportunity to provide an intervention that addresses both IPV and depression.

The range of cultural, geographical, economic, linguistic, religious, socio-political, health system and other differences between rural Ethiopia and the largely middle-income settings of most RCTs published to date supports the need for research evaluating PST adapted for women experiencing IPV (PST-IPV) in this context.

In this randomised feasibility trial and process evaluation of perinatal PST-IPV in rural Ethiopia, we aim to determine the feasibility and acceptability of the intervention and study design to inform a future fully powered RCT. Specific objectives are to:

In this three-arm feasibility trial, we will randomise eligible women (with depressive symptoms, functional impact and past-year IPV) to PST-IPV, standard PST or enhanced usual care (information about relevant sources of support). All arms represent additions to standard clinical care, which does not currently provide any routine interventions for perinatal depression or IPV.

This study is linked to a two-arm feasibility trial that will randomise eligible women (with depressive symptoms and functional impact) to standard PST or information only, the protocol of which is reported separately (Bitew T, Keynejad RC, Honikman S, Sorsdahl K, Myers B, Fekadu A, et al. Brief problem-solving therapy for perinatal depression in rural Ethiopia: protocol for a randomised feasibility study.) (see Fig. 1).

The study will be conducted in selected health facilities in the predominantly rural areas of Gurage zone (projected population 1,712,506) and Silt’e zone (projected population 1,043,242) in the Southern Nations, Nationalities, and Peoples’ Region of Ethiopia [51]. Primary health care is structured so that the nurse, midwife and health officer-run health centres (serving a population of 25,000–40,000) are linked to five community health posts (serving a population of 3000–5000) staffed by one or two health extension workers (HEWs) each, with access to a single primary hospital for more specialist care. HEWs, who have completed high school and received 1 year of undergraduate-level training [52], provide a first antenatal contact before referring women for further antenatal care (ANC) at a health centre or primary hospital and maintain contact with women during pregnancy.

This study builds on the programme for improving mental health care (PRIME) study [53], which integrated mental health into primary and maternal care in five LMICs, including the Gurage zone, Ethiopia [54]. In PRIME, a district-level mental health plan was developed in collaboration with key stakeholders and comprised interventions at the community, health facility and health system level. At the facility level, PRIME trained primary and maternal care staff using the mental health gap action programme (mhGAP) intervention guide of the WHO, which guides non-mental health specialists through clinical diagnostic and treatment algorithms for prioritised mental, neurological and substance use disorders [55]. The PRIME study investigators identified low detection rates of depression, which may be related in part to a lack of acceptable treatment options. Formative work was therefore conducted to inform adaptation of a brief psychological intervention for depression. In a nested study, PST was then adapted for antenatal women in this rural Ethiopian setting.

A systematic review and meta-analysis [21], further qualitative interviews and theory of change workshops (Bitew T, Keynejad RC, Honikman S, Sorsdahl K, Myers B, Fekadu A, et al. Brief psychological intervention for antenatal depression: a qualitative study.) (Keynejad RC, Bitew T, Mulushoa A, Tol W, Howard LM, Hanlon C. Adapting brief, task-shared problem-solving therapy for women experiencing intimate partner violence in rural Ethiopia: a qualitative study.) were then used to adapt this locally tailored PST intervention to address the needs and experiences of women affected by IPV. The preliminary theory of change visualises health worker perspectives on the components, hypothesised mediators, intermediate and long-term outcomes of PST-IPV intervention, and factors anticipated to influence the delivery and implementation of PST-IPV (see Supplementary file 1).

Adaptation for IPV focused on international guidelines [5], which recommend identifying women experiencing IPV, training health care providers about IPV, and providing woman-centred care and support when IPV is disclosed. PST-IPV will apply a PST approach in the context of IPV, enabling IPV-related problem solving and management of mental health-related symptoms.

As a feasibility trial, this study is not powered to detect intervention efficacy, but rather to estimate feasibility parameters to inform a future RCT, and test intervention and research protocols. With a total sample size of 75 (25 participants randomised to PST-IPV, 25 to PST and 25 to enhanced usual care), a drop-out rate of 30% can be estimated to within a 95% confidence interval of ±3%. To estimate the standard deviation of the primary feasibility outcome measure to inform a future RCT sample size calculation, recommended feasibility trial sample sizes range between a total of 24 and 50 across two arms [56, 57].

Research staff will consult health care workers based in primary hospitals and/or health centres in Gurage and Silt’e zones to identify potentially eligible women meeting those inclusion criteria about which information is held for screening. Potentially eligible women will be approached through ANC clinics and HEW home visits by research staff and provided with written and verbal information in Amharic, before being invited to give written, informed consent to initial screening. Non-literate women will signify their consent by finger print. A high school-educated assistant will act as a witness to confirm that the information sheet has been read aloud correctly to non-literate women. Women screened as eligible to participate in the randomised feasibility trial will then be invited to give written, informed consent to participate. As with screening, non-literate women will signify their consent to participate in the trial by witnessed finger print.

Due to potential risks of abusive partners learning of women’s involvement, information sheets, consent forms and other study paperwork will be kept in the locked research office after being read and signed but will be accessible to women at their request. Due to logistical challenges affecting women’s daily lives in this setting, it is not possible to give prospective participants 24 h to decide whether to take part. However, a minimum of 30 min will be allowed for the woman to make up her mind about participating in the study.

Consecutive, potentially eligible women who provide informed consent will be screened for depressive symptoms and a history of past-year IPV after their ANC appointment. Depressive symptoms will be screened for using the locally validated [58] nine-item Patient Health Questionnaire (PHQ-9) [59]. To screen for IPV exposure, research staff will first read the introductory paragraph of the Amharic translated [60] Conflict Tactics Scale [61] to potential participants (or they may read themselves, if literate) to ameliorate stigma they may feel towards disclosing IPV. A five-item ‘non-graphic language’ screening test previously used in this and other LMIC contexts and found to be a valid measure of IPV [62] will then be administered. Finally, items from the WHO multi-country study [42] of women’s health and domestic violence, previously used in this setting, will be used to ask about experiences of IPV in the past year.

All screened women scoring five or more on the PHQ-9 [63, 64] and endorsing any functional impact of symptoms (the tenth item) will be invited to participate in the research study. Endorsement of the tenth item will be defined as answering “somewhat”, “very” or “extremely difficult” to the question “over the last two weeks, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?”.

Consenting women who disclose any past-year IPV during screening will be randomised to one of PST-IPV, standard PST or enhanced usual care, whereas consenting women reporting no IPV on baseline measurements will be randomised to one of standard PST or enhanced usual care for the separate, nested PST feasibility trial (see Fig. 1).

All women screened as eligible to participate will be informed about the study and given the opportunity to ask questions before being invited to consent to participate in the randomised feasibility trial. Women consenting to participate will first receive their routine clinical care and then participate in a baseline interview using fully structured questionnaires. If screening or this assessment identify any sources of concern (e.g. suicidal ideation, risks to herself or others), the researcher will discuss these with the woman and explain the need to share them with her health care professional, before involving them. To be eligible to participate in the PST-IPV components of the overall study, women must meet the eligibility criteria (see below).

Women can be included if they:

Women are required to speak Amharic, the official language of the region, so that they can access all translated study materials, verbally or in writing. Relationships are defined as any romantic or sexual interaction within or outside marriage.

PHQ-9 has been validated in the study area in both primary care [63] and ANC attendees (area under the receiver operating characteristic curve 0.91, 95% confidence interval 0.86–0.96) [64]. For primary care attendees a score of five or more was the optimal cut-off for identifying possible depressive disorder. For antenatal women, a cut-off of four or more was optimal. However, since at the optimal cut-offs the positive predictive value was less than 50%, in this study women scoring above the cut-off (five or more) will be included if they also report difficulty in their day-to-day activities (measured using the PHQ-9 tenth item).

Women will be excluded if they:

All women endorsing question nine of PHQ-9 about suicidal thoughts or self-harm behaviours will receive the Amharic [63] Mini-International Neuropsychiatric Interview suicidality scale [65]. Women scoring 17 or above on the Mini-International Neuropsychiatric Interview (indicating high suicide risk) will be excluded from participation as part of a stepped-care model [54]. They will be referred instead to a mental health-trained primary care worker who will employ mhGAP [55] criteria to assess for imminent risk of self-harm or suicide. Women assessed as being at imminent risk will be referred to a psychiatric nurse in the primary hospital for escalation of their care. The attendance of participants at referred appointments will be facilitated by the study, including any attendant transportation costs to access off-site services. Any psychotic symptoms and risks identified during the trial will be discussed with the project mental health professional and women will be referred for specialist mental health care if required. Women assessed as eligible to participate at the time of screening but who do not consent to take part will receive the same stepped mental health care model, depending on their symptoms and any imminent risks.

Otherwise eligible women reporting no past-year IPV exposure will be invited to participate in the separate, nested feasibility trial of standard PST for depression but will not be eligible for this study of PST-IPV.

Interested women who cannot read will be read aloud the information sheet. If unable to write, participants will record a thumb print, signed by a literate witness (a high school-educated assistant) after confirming that the information sheet has been read aloud correctly; otherwise, participants will provide written informed consent. Study documents will be kept in the locked research office but will be accessible to women at their request. The information sheet includes details of how participants can access compensation, if required.

All participants will be reimbursed for their time attending research interviews in addition to transport costs and any additional expenses incurred. Participants will be reimbursed for transport costs to attend PST or PST-IPV sessions but will not be compensated for their time during these sessions. This is to determine the acceptability of psychological intervention sessions to women and enable calculation of drop-out rates. A fund will be available to assist participants disclosing IPV who wish to access support services (for example. to facilitate transport to a government social support office or police station).

Research staff will telephone the Centre for Innovative Drug Development and Therapeutic Trials for Africa data manager, based at the College of Health Sciences, Addis Ababa University, Ethiopia, who is not otherwise involved in this study, to allocate each participant to a study arm (PST-IPV, standard PST or enhanced usual care) using a random number list generated by the trial statistician (GM), who is not otherwise involved in data collection processes. The data manager will telephone a separate member of research staff based in Silt’e, who will inform a clinician trained to deliver PST-IPV or standard PST when a new participant has been allocated to that trial arm. Research staff will provide participants with an unmarked card indicating their enrolment in the trial and agree a date and time to attend their first session of PST-IPV or standard PST. When they attend, they will be expected by their allocated clinician. For participants allocated to enhanced usual care, their antenatal care provider will provide them with information about sources of support and the research assistant will arrange a follow-up appointment 9 weeks later.

Women who do not attend their appointed date and time will be contacted using the telephone number (where applicable) and/or household details they have provided at trial enrolment or through their allocated HEW, up to a maximum of three attempts.

Given qualitative differences between PST and PST-IPV, clinicians delivering the intervention cannot be masked to participant allocation. To avoid contamination, PST-IPV, standard PST and enhanced usual care will be delivered by different practitioners who have either attended a PST-IPV or a standard PST training course, or received basic training to provide enhanced usual care. Post-intervention outcome assessments will be conducted by trained, independent assessors (working in separate offices from practitioners delivering interventions and not travelling together) masked to intervention allocation, with a minimum post-high school diploma level of education. Independent assessors will document any incidents of unmasking. Data analysts will also be masked to intervention allocation.

Participants randomised to PST-IPV or standard PST will attend four intervention contacts within a maximum of 8 weeks. Where birth occurs before the end of treatment, the feasibility of continuing PST-IPV or standard PST post-natally will also be assessed.

Both manualised interventions will be delivered by trained health workers, such as nurses and midwives, supervised by Psychology Masters-level qualified research staff, with access to a project mental health professional for clinical concerns. Responses to concerns and risk incidents will follow standard operating procedures (SOPs). Government-employed health workers trained to deliver the interventions will be paid for their time.

Both PST-IPV and standard PST intervention arms follow the same structure of four sessions, based on the model successfully employed in South Africa and adapted for this rural Ethiopian setting [27, 66]. Session 1 focuses on basic psychoeducation, introduction to PST, identifying the most important things in the woman’s life and categorising problems into three groups. Session 2 focuses on revising session 1, coping strategies for ‘group A’ problems (which are upsetting but do not influence the most important things in the woman’s life) and the six-step problem solving method for ‘group C’ problems (which are important and can be solved). Session 3 focuses on revising session 2, coping strategies for ‘group B’ problems (which are important but cannot be solved) and psychoeducation about the phases of coping with bereavement and loss. Session 4 focuses on revising session 3, using problem solving skills in everyday life and reviewing how the coping strategies worked in practice. All sessions involve assigning and reviewing take-home activities.

PST-IPV content and materials are adapted to address the needs and experiences of women affected by IPV, whilst standard PST content and materials are generic. Adaptations for women experiencing IPV include training staff using content and materials from the new WHO curriculum on caring for women subjected to violence [67], attention to safety and sensitivity where women list IPV-related problems during sessions (including training with worked examples of problem solving focused on IPV), and adaptation of PST case studies to reflect common problems associated with IPV.

Participants randomised to PST-IPV or standard PST will attend a total of six contacts: one baseline pre-intervention research assessment, four intervention contacts and a follow-up research assessment contact 9 weeks after recruitment. The feasibility of follow-up 9 weeks after recruitment will be assessed and may change, depending on gestation of pregnancy at the time of enrolment.

One-third of participants will be randomised to information only about sources of support (enhanced usual care; see Supplementary file 2). They will attend two contacts: one pre-intervention assessment at which they are provided with information about relevant sources of support, and one follow-up assessment 9 weeks later.

In our meta-analysis we found that randomisation of control group participants with depression, anxiety, PTSD or psychological distress symptoms and IPV exposure to waiting list, treatment as usual, or enhanced usual care arms is widespread [21]. This, coupled with the lack of any standard intervention provision for perinatal depression and/or IPV in rural Ethiopia and the provision of safeguards in the study design, justify the use of a control arm, which comprises enhanced usual care (provision of information about sources of support).

Women will be assessed at baseline and then 9 weeks later in a private room of the health care facility at a time convenient to them (Fig. 2). During these assessments, fully structured measures will be administered to consenting participants in an interview format. The time taken to complete planned questionnaires will be tested prior to commencing the study. Where administration of study measures takes longer than 1 h per session or is experienced by research staff or participants as unduly burdensome, instruments will be removed from the assessment questionnaire. This information will contribute to the study’s process evaluation.

We will follow the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials [83].

We will review process evaluation data for indications of sub-group differences in uptake, recruitment and retention of participants by site, health worker, recruitment method/site, participant (age, education level, religion, parity) and health worker characteristics (age, profession, years of experience). Quantitative scale results will be analysed using STATA [84].

Feasibility studies are not powered to calculate effect sizes but standard deviations and drop-out rates will be calculated on the intention-to-treat sample (all women who were randomised, regardless of uptake of the intervention) to inform sample size calculation for a future RCT, for outcome measures, recruitment rates and drop-out rates. Quantitative process data will determine future RCT design improvements, such as session number and duration, recruitment, outcome measures, and strategies preventing contamination. The extent of missing data will be evaluated as part of the process evaluation. For clinical outcome measures, missing data will not be imputed. Rather, standard deviations will be calculated using data from participants for whom outcome measures are available.

We will apply the framework approach to thematic analysis of qualitative interviews [85] and triangulate the results with quantitative process data through researcher meetings. The full descriptive analysis will include contextual barriers and facilitators influencing study outcomes.

Strategies to ensure data protection, quality assurance and dissemination of results are outlined in Supplementary file 3 and data collection forms are provided in Supplementary file 4. Ethical approval has been provided by the Institutional Review Board of the College of Health Sciences, Addis Ababa University, Ethiopia (protocol number: 032/19/CDT) and the Psychiatry, Nursing & Midwifery subcommittee of King’s College London’s College Research Ethics Committee, UK (reference: HR-18/19–9230); see Supplementary file 5.

This study involves recruitment of potentially vulnerable women, disclosure of IPV, and detecting depression, anxiety and PTSD symptoms. The SOP therefore outlines actions to mitigate potential risks. If participants disclose current exposure to IPV, research staff will be trained to listen non-judgementally, offer privacy and confidentiality, and information about local agencies who can provide assistance (see Supplementary file 2) [42] in keeping with WHO guidelines, irrespective of the study arm.

This is the first study of its kind in this rural Ethiopian setting. Most research into psychological interventions for anxiety and depression in LMICs comes from urban or peri-urban areas of middle-income countries, and only two to date have been adapted for women experiencing IPV [22, 23]. Neither of these interventions trialled a brief intervention, embedded within ANC in a rural, low-income country setting. The results will be informative to researchers developing brief psychological interventions adapted for this and other resource-restricted settings.

This three-arm randomised feasibility trial benefits from a shared control group with a separate, nested study of standard PST. The efficiency of shared control groups is well documented [86] and multi-arm trials are recognised for their simplicity, speed and reduced cost relative to two-arm trials [87]. The study focus on evaluating and refining the feasibility of both the PST-IPV intervention and the study design using a mixed-method process evaluation ensures that improvements will be made prior to a definitive RCT.

The sensitivity of discussing mental health and IPV, logistical challenges to women’s participation in research, limited education and literacy and competing priorities on ANC staff time are all anticipated challenges to the successful completion of this study. These will be mitigated by stringent ethical conduct emphasising confidentiality and supporting women at risk of IPV, supporting women to access intervention arms, adapting recruitment and intervention procedures to accommodate variable education and comprehensive training and supervision of health workers. However, unforeseen geopolitical eventualities may arise in rural, low-income settings which compromise the conduct and completion of this protocol as planned. The benefit of this feasibility trial is to identify study design problems as early as possible in order to mitigate their impact on the resultant research evidence.