Cognitive Behavioral Therapy for Individuals With Low Literacy and Perinatal Depression: A Randomized Clinical Trial.

Importance: Perinatal depression is common in sub-Saharan Africa, yet treatment gaps are substantial. Cognitive behavioral therapy (CBT) is effective but relies on written materials. Objective: To evaluate the efficacy of a culturally adapted CBT intervention delivered by lay counselors to women with perinatal depression in rural Sierra Leone. Design, Setting, and Participants: This study was an individually randomized, outcomes assessor- and investigator-blinded, clinical trial of an adapted CBT intervention vs enhanced usual care. The trial was conducted in 6 government-run antenatal clinics in Pujehun District, Sierra Leone, which has limited infrastructure, low literacy, high maternal undernutrition, and no perinatal mental health services. Participants were drawn from a concurrent antenatal nutritional supplementation trial between November 2023 and April 2025. Eligible participants were pregnant and postpartum women who were undernourished and had depression (scoring ≥9 on the adapted Patient Health Questionnaire-9 [aPHQ-9]). Intervention: Participants were randomized 1:1 to receive 6 weekly sessions of CBT adapted for delivery without written materials or only enhanced usual care. All participants received enhanced usual care, which consisted of antenatal nutritional supplementation, monthly malaria chemoprophylaxis, and 2 doses of azithromycin. Main Outcomes and Measures: The primary outcome was aPHQ-9 score at 8 weeks. Secondary outcomes included clinically meaningful symptom reduction (decrease of >3 points) and remission (aPHQ-9 score <5). Results: Among 881 women screened, 155 (median [IQR] age, 19 [18 to 22] years) were randomized to CBT (80 women) or control (75 women) groups. Postintervention data were available for 140 of 153 eligible participants (91.5%). Median aPHQ-9 scores at postintervention were lower in the CBT group than the control group (median difference, -4; 95% CI, -5 to -3; P < .001). Clinically meaningful symptom reductions were more common with CBT vs control (72 participants [96.0%] vs 36 participants [55.4%]; odds ratio, 19.33; 95% CI, 6.33 to 84.59; P < .001), and 59 CBT participants (78.6%) achieved remission compared with 22 participants (33.8%) in the control group (odds ratio, 7.21; 95% CI, 3.39 to 15.33; P < .001). Attenuated effects persisted through 9 months after pregnancy (median difference in aPHQ9 for intervention vs control, -1; 95% CI, -2 to 0; P = .02). Conclusions and Relevance: In this study, a culturally adapted CBT intervention delivered by lay counselors reduced depressive symptoms approximately 8 weeks after enrollment compared with enhanced usual care. These findings suggest that CBT adapted for low-literacy settings may offer a scalable model for treatment where mental health professionals are scarce. Trial Registration: ClinicalTrials.gov Identifier: NCT05949190.