Cognitive Behavioral Therapy for Individuals With Low Literacy and Perinatal Depression: A Randomized Clinical Trial
In rural Sierra Leone, a spoken, culturally adapted cognitive behavioral therapy program delivered by local counselors reduced depression symptoms and increased remission versus enhanced usual care.
*Individually randomized, assessor-blinded clinical trial; Level 1b (OCEBM).
*Individually randomized, assessor-blinded clinical trial; Level 1b (OCEBM).
Citation
Kleban E, Lee A, Koroma A, Hendrixson DT, Duncan J, Manary MJ, Stephenson KB. Cognitive Behavioral Therapy for Individuals With Low Literacy and Perinatal Depression: A Randomized Clinical Trial. JAMA Network Open. 2026;9(5):e2611101. doi:10.1001/jamanetworkopen.2026.11101. Trial registration: NCT05949190.
Background
Perinatal depression is common in sub-Saharan Africa, but treatment access is limited. Standard cognitive behavioral therapy often depends on written materials, creating barriers where literacy is low.
Patients
Pregnant or postpartum women in rural Sierra Leone who were undernourished and screened positive for depression (score ≥9 on an orally delivered, locally adapted Patient Health Questionnaire-9). Exclusions: not pregnant at randomization (2 participants removed).
Intervention
Six weekly 45–60 minute individual cognitive behavioral therapy sessions adapted to avoid reading/writing (oral practice, role-play, drawings), delivered by trained lay counselors.
Control
Enhanced usual care without counseling (nutrition supplementation, malaria prevention, and antibiotic doses within a concurrent nutrition program).
Outcome
Primary: adapted Patient Health Questionnaire-9 score (0–27) at ~8 weeks. Secondary: symptom improvement >3 points; remission (score <5).
Follow-up Period
Primary endpoint at ~8 weeks; additional follow-up to 9 months after pregnancy (antenatal enrollees).
Results
| Outcome | Therapy group | Control group | Effect | NNT |
|---|---|---|---|---|
| Depression symptom score at ~8 weeks (primary) | Median 2 | Median 7 | Median difference −4 (95% CI, −5 to −3) | — |
| Remission at ~8 weeks (score <5) | 78.6% | 33.8% | Odds ratio 7.21 (95% CI, 3.39 to 15.33) | 3 |
| Improvement >3 points at ~8 weeks | 96.0% | 55.4% | Odds ratio 19.33 (95% CI, 6.33 to 84.59) | 3 |
Outcome assessors and investigators were blinded; participants and counselors were not. Most therapy participants (86.1%) attended all six sessions.
Limitations
Without an attention-matched control, some benefit may reflect extra weekly contact rather than therapy content alone. The depression questionnaire was adapted for this setting, which may limit comparison with other studies. Participants were undernourished and largely enrolled during pregnancy, so results may not generalize to all perinatal patients.
Funding
Coefficient Giving; curriculum supported by Every Child Fed.
Clinical Application
Consider lay-counselor, low-literacy cognitive behavioral therapy for perinatal depression where specialists are scarce; benefits were large at 8 weeks, with smaller but lasting improvement.
Discussion
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In this individually randomized, outcomes-assessor–blinded RCT, lay-counselor, low-literacy–adapted CBT lowered 8‑week depressive symptoms vs enhanced usual care (aPHQ‑9 median difference −4; 95% CI −5 to −3). Given no participant blinding or attention-matched control, how confident are you in validity and would this change your practice? The trial reported remission (aPHQ-9 <5) of 78.6% with CBT vs 33.8% with control, with an odds ratio (OR) of 7.21. Which statement best describes interpretation of the OR in this context?