Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled feasibility trial

Abstract Background: Despite a high prevalence of antenatal depression in low- and middle-income countries, there is very little evidence for contextually adapted psychological interventions delivered in rural African settings. The aims of this study are: (1) to examine the feasibility of procedures for a future fully powered efficacy trial of contextually adapted brief Problem Solving Therapy (PST) for antenatal depression in rural Ethiopia, and (2) to investigate the acceptability, fidelity and feasibility of delivery of PST in routine antenatal care. Methods: Design: A randomized, controlled, feasibility trial and mixed method process evaluation. Participants: Consecutive women attending antenatal clinics in two primary care facilities in rural Ethiopian districts. Eligibility criteria: 1) Disabling levels of depressive symptoms (Patient Health Questionnaire (PHQ-9) score of five or more and positive for the 10th disability item); 2) gestational age 12-34 weeks; 3) aged 16 years and above, 4) planning to live in the study area for at least six months; 5) no severe medical or psychiatric conditions. Intervention: Four sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks. Control: enhanced usual care (EUC). Sample size: n=50. Randomisation: individual randomisation stratified by intimate partner violence (IPV). Allocation: central phone allocation. Outcome assessors and statistician masked to allocation status. Primary feasibility trial outcome: dropout rate. Primary future efficacy trial outcome: change in PHQ-9 score, assessed nine weeks after recruitment. Secondary outcomes: anxiety symptoms, trauma symptoms, intimate partner violence, disability, healthcare costs at 9 weeks; postnatal outcomes (perinatal and neonatal complications, onset of breast feeding, child health) assessed 4-6 weeks postnatal. Other trial feasibility indicators: recruitment, number and duration of sessions attended. Audio-recording of randomly selected sessions and in-depth interviews with purposively selected participants, healthcare providers and supervisors will be analysed thematically to explore the acceptability and feasibility of the trial procedures and fidelity of the delivery of PST. Discussion: The findings of the study will be used to inform the design of a fully-powered efficacy trial of brief PST for antenatal depression in routine care in rural Ethiopia. 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 Funding: This work is supported through the DELTAS Africa Initiative [DEL-15-01].