Section of Women's Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Trials. 2020 Jun 1;21(1):454. doi: 10.1186/s13063-020-04331-0.
In rural Ethiopia, 72% of women are exposed to lifetime intimate partner violence (IPV); IPV is most prevalent during pregnancy. As well as adversely affecting women's physical and mental health, IPV also increases the risk of child morbidity and mortality associated with maternal depression, thus making antenatal care an important opportunity for intervention. Adapting generic, task-shared, brief psychological interventions for perinatal depression and anxiety to address the needs and experiences of women affected by IPV may improve acceptability to women and feasibility for health workers. This randomised controlled feasibility trial will compare brief problem solving therapy (PST) specifically adapted for pregnant women experiencing IPV (PST-IPV) with standard PST and enhanced usual care to determine the feasibility of a future fully powered randomised controlled trial.
Seventy-five pregnant women scoring five or more on the Patient Health Questionnaire, endorsing a tenth question about functional impact and reporting past-year IPV, will be recruited from antenatal care clinics in predominantly rural districts in Ethiopia. Consenting participants will be randomised to either four sessions of PST-IPV, four sessions of standard PST or information about sources of support (enhanced usual care) in a three-arm design. The interventions will be delivered by trained, supervised antenatal care staff using a task-sharing model. Assessments will be made at baseline and after 9 weeks by masked outcome assessors and will include measures of depression symptoms (primary outcome), post-traumatic stress, anxiety symptoms, functional impact, past-month IPV and hypothesised mediators (secondary outcomes). A mixed-method process evaluation will determine the feasibility of a future randomised controlled trial, assess the feasibility, acceptability, fidelity and quality of implementation of PST-IPV, generate testable hypotheses about causal mechanisms, and identify potential contextual factors influencing outcomes.
Despite mental health being a critical concern for women experiencing IPV, there is limited evidence for brief, task-shared psychological interventions adapted for their needs in low- and middle-income countries. Contextually tailored interventions for pregnant women experiencing IPV in low- and middle-income countries require development and process evaluation. This randomised controlled feasibility trial will yield results on the feasibility of conducting a fully powered trial, relevant to researchers, primary and antenatal care clinicians in resource-limited settings.
Pan-African clinical trials registry: PACTR202002513482084. Prospectively registered on 13 December 2019.
在埃塞俄比亚农村，72%的妇女一生中都曾遭受过亲密伴侣暴力（IPV）；IPV 在怀孕期间最为普遍。IPV 不仅会对妇女的身心健康造成不良影响，还会增加与产妇抑郁相关的儿童发病和死亡风险，因此，产前保健是干预的一个重要机会。针对受 IPV 影响的妇女的需求和经历，将通用的、任务分担的、简短的心理干预措施（如针对围产期抑郁和焦虑的问题解决疗法）进行改编，可能会提高妇女的接受度和卫生工作者的可行性。这项随机对照可行性试验将比较专门针对遭受 IPV 的孕妇的简短问题解决疗法（PST-IPV）与标准 PST 和增强型常规护理，以确定未来完全随机对照试验的可行性。
从埃塞俄比亚主要农村地区的产前保健诊所招募 75 名 PHQ-9 评分≥5 分、回答第 10 个关于功能影响的问题并报告过去一年有 IPV 经历的孕妇。同意参加的参与者将被随机分配到 PST-IPV 四疗程组、标准 PST 四疗程组或信息支持增强组（增强型常规护理）三组中。干预措施将由经过培训和监督的产前保健工作人员使用任务分担模式进行。通过盲法结局评估者在基线和 9 周后进行评估，评估包括抑郁症状（主要结局）、创伤后应激、焦虑症状、功能影响、过去一个月的 IPV 和假设的中介因素（次要结局）。一项混合方法的过程评估将确定未来随机对照试验的可行性，评估 PST-IPV 的可行性、可接受性、保真度和实施质量，提出关于因果机制的可检验假设，并确定影响结局的潜在背景因素。
尽管心理健康是遭受 IPV 的妇女的一个关键关注点，但针对她们需求的、简短的、任务分担的心理干预措施在中低收入国家的证据有限。针对中低收入国家遭受 IPV 的孕妇的情境化定制干预措施需要进一步开发和进行过程评估。这项随机对照可行性试验将产生关于开展全面试验的可行性的结果，这对资源有限环境下的研究人员、初级保健和产前保健临床医生都具有重要意义。
泛非临床试验注册中心：PACTR202002513482084。于 2019 年 12 月 13 日前瞻性注册。
