Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia

Evidence for the feasibility of brief psychological interventions for pregnant women experiencing intimate partner violence (IPV) in rural, low-income country settings is scarce. In rural Ethiopia, the prevalence of antenatal depressive symptoms and lifetime IPV are 29% and 61%, respectively. We aimed to assess the feasibility and related implementation outcomes of brief problem-solving therapy (PST) adapted for pregnant women experiencing IPV (PST-IPV) in rural Ethiopia, and of a randomised, controlled feasibility study design. We recruited 52 pregnant women experiencing depressive symptoms and past-year IPV from two antenatal care (ANC) services. Consenting women were randomised to PST-IPV (n = 25), 'standard' PST (not adapted for women experiencing IPV; n = 12) or enhanced usual care (information about sources of support; n = 15). Masked data collectors conducted outcome assessments nine weeks post-enrolment. Addis Ababa University (#032/19/CDT) and King's College London (#HR-18/19-9230) approved the study. Fidelity to randomisation was impeded by strong cultural norms about what constituted IPV. However, recruitment was feasible (recruitment rate: 1.5 per day; 37% of women screened were eligible). The intervention and trial were acceptable to women (4% declined initial screening, none declined to participate, and 76% attended all four sessions of either active intervention). PST-IPV was acceptable to ANC providers: none dropped out. Sessions lasting up to a mean 52 minutes raised questions about the appropriateness of the model to this context. Competence assessments recommended supplementary communication skills training. Fidelity assessments indicated high adherence, quality, and responsiveness but assessing risks and social networks, and discussing confidentiality needed improvement. Adjustments to optimise a future, fully powered, randomised controlled trial include staggering recruitment in line with therapist availability, more training on the types of IPV and how to discuss them, automating randomisation, a supervision cascade model, and conducting post-intervention outcome assessments immediately and three months postpartum. Registration: Pan African Clinical Trials Registry #PACTR202002513482084 (13/12/2019): https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9601.