BlandineUwingabire/Randomized-Clinical-Trial

In this project, we designed a randomized controlled trial to evaluate a hybrid mental health intervention in Rwanda that combines USSD-based digital support with in-person, CHW-led problem-solving therapy. The study assesses effectiveness, engagement, and feasibility compared to usual care for adults with major depressive disorder. Hybrid USSD-Based + In-Person Problem-Solving Therapy RCT (Rwanda) Project Overview This project presents the design of a randomized controlled trial (RCT) evaluating a hybrid mental health intervention for adults with Major Depressive Disorder (MDD) in Rwanda. The intervention combines community health worker (CHW)–led, in-person Problem-Solving Therapy (PST) with low-bandwidth digital support delivered via USSD/SMS, compared against usual care. The study is motivated by persistent gaps in access to mental health services in low- and middle-income countries, where shortages of specialized providers and structural barriers delay treatment. By integrating task-shifting with simple digital reinforcement, the project explores a scalable and context-appropriate model for improving mental health outcomes. Study Objectives Primary objective To determine whether hybrid PST leads to greater reductions in depressive symptoms (PHQ-9) at 12 weeks compared to usual care. Secondary objectives To assess remission rates at 12 and 24 weeks To evaluate functional improvement using WHODAS To examine participant engagement with the digital platform To assess adherence to CHW-delivered therapy sessions Study Design Design: Two-arm, individually randomized, parallel-group RCT Setting: Gasabo and Huye districts, Rwanda Population: Adults (≥20 years) diagnosed with MDD (PHQ-9 ≥10) Randomization: 1:1 allocation, stratified by district Follow-up: Baseline, 6 weeks, 12 weeks, and 24 weeks Intervention Hybrid PST (Intervention arm) Participants receive: Six structured, in-person PST sessions delivered by trained CHWs Six alternating follow-up sessions SMS/USSD messages for mood monitoring, motivation, and reminders Usual care (Control arm) Participants continue receiving standard mental health services available within the existing health system. Outcomes and Analysis Primary outcome: Change in PHQ-9 score at 12 weeks Secondary outcomes: Remission (PHQ-9 <5), WHODAS s …