Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: randomised, controlled feasibility trial in primary care in rural Ethiopia

Background: We adapted problem-solving therapy (PST) to support improved treatment of antenatal depression in maternal care platforms in Ethiopia. In this study, we aimed to: (1) assess acceptability, fidelity, feasibility and potential efficacy of PST for antenatal depression in rural Ethiopia, and (2) examine the feasibility of procedures of a randomised, controlled study design, to inform a future, fully-powered randomised controlled trial (RCT). Methods: We recruited fifty consecutive women attending primary healthcare-based antenatal care in two PHC facilities in (Bui and Kella), based on pre-established eligibility criteria. A randomised, controlled feasibility trial design with two parallel groups was employed. The intervention arm received four sessions of a contextually adapted version of PST. Enhanced Usual Care (EUC) involved antenatal care counselling, and information about sources of support. Assessments were conducted at baseline and nine weeks after randomisation. We used a locally validated version of the Patient Health Questionnaire-9 (PHQ-9) to assess antenatal depressive symptoms. A range of other outcomes, including functioning (WHODAS-12), anxiety (GAD-7) and process outcomes were assessed. Descriptive statistics were employed to summarise process indicators, participant characteristics and trial outcome measures. Results: Out of a total of 335 antenatal women approached for initial eligibility assessment over a period of 20 days, 154 (46%) met initial eligibility to proceed to screening. After screening and the consent process, we randomised the remaining 50 eligible women into PST and EUC arms; 64% completed the intervention. Almost all outcome measures favoured the intervention arm compared to the EUC arm. Trial procedures such as participant recruitment and concealment were feasible. Supervision reports indicated that healthcare workers (HCWs) adhered to most of the content of the intervention except in situations when women reported not having problems or worries. Supervision reports indicated that HCWs appreciated skills gained in PST. However, they commented on the need to shorten trainer demonstrations of some sessions while focusing on trainees’ practical exercises and using video recorded role play. Conclusion: Participant recruitment, screening, randomization, masking, as well as the intervention delivery process, were feasible. Future design of efficacy trials need to emphasise practical exercises to support training. Trial registration: The protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578. The protocol has also been published: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8