A cognitive behavioral therapy program designed for low-literacy end-users with perinatal depression in Sierra Leone: an investigator- and outcomes assessor-blinded, controlled randomized trial

Background: Perinatal depression is common in Sub Saharan Africa, where mental health services are limited and literacy levels low. Cognitive behavioral therapy (CBT) is effective in high income settings, but uses written materials. We evaluated the effectiveness of a culturally adapted CBT intervention designed for non-literate women with perinatal depression, delivered by trained lay counselors in rural Sierra Leone. Methods: This study was an outcomes assessor and investigator blinded, individually randomized controlled trial of an adapted CBT program versus standard care (no mental health intervention) among undernourished pregnant and postpartum women with depression in Pujehun, Sierra Leone. Participants were drawn from the COGENT cohort, a randomized, controlled trial of antenatal nutritional supplementation. Depression was identified using the adapted Patient Health Questionnaire9 (aPHQ9). Eligible women scoring ≥9 on the aPHQ9 were randomized 1:1 to receive six weekly CBT sessions or standard care. The primary outcome was aPHQ9 score at 8 weeks post-randomization. Secondary outcomes included clinically meaningful symptom reduction and depression remission (aPHQ9 <5). Outcomes were analyzed using a modified intention to treat analyses. Findings: Among the 881 women screened, 155 were randomized to CBT (n=80) or control (n=75) groups. Endline data were available for 140/ 153 participants (92%). Median aPHQ9 scores at 8 weeks were lower in the CBT group than the control group (median difference 4, 95% CI 5 to 3; p<0.001). Clinically symptom reductions (>3 point drop) were more common in the CBT group (96% vs 55%; OR 19, 95% CI 6 to 86; p<0.001), and 79% of CBT participants achieved remission compared to 34% of controls (OR 7, 95% CI 4 to 16; p<0.001). Effects were sustained through 9 months postpartum. No significant effect heterogeneity was found across subgroups. Inter-assessor reliability of aPHQ9 scoring was high (ICC >0.90). Interpretation: A culturally adapted CBT program reduced perinatal depression symptoms in malnourished antenatal and postpartum women in rural Sierra Leone, with sustained effects through nine months postpartum. This study demonstrates the feasibility and effectiveness of delivering CBT via trained lay counselors. Funding provided by Open Philanthropy.