Developing and testing tele-support psychotherapy using mobile phones for depression among youth in Kampala district, Uganda: study protocol for a pilot randomized controlled trial

Introduction: In the post-COVID-19 era, depressive disorders among youth have risen significantly, creating an urgent need for accessible, cost-effective mental health interventions. This study adapts Group Support Psychotherapy into Tele-Support Psychotherapy (TSP) via mobile phones. It aims to evaluate its feasibility, acceptability, effectiveness, and cost-efficiency in addressing mild to moderate depression among youth in central Uganda. Methods and analysis: This study will use a mixed-methods approach, starting with a qualitative phase to adapt Group Support Psychotherapy into Tele-Support Psychotherapy (TSP) via mobile phones. Guided by ecological theories and the Unified Theory of Acceptance and Use of Technology (UTAUT), focus group discussions and interviews with youth, mental health professionals, and stakeholders will inform the development of a youth-tailored call platform integrated into Rocket Health Africa's telehealth services. Data will be analyzed using grounded theory and MAXQDA Analytics Pro 2022 to guide intervention adaptation. An open-label randomized controlled trial will enroll 300 youth (15–30 years) with mild to moderate depression from Kampala, Uganda, to evaluate Tele-Support Psychotherapy (TSP). Participants will be randomized to TSP with standard mental health services (SMHS) or SMHS alone. Primary outcomes include feasibility and acceptability, with secondary outcomes assessing cost-effectiveness, depressive symptom changes, and social support. Intention-to-treat analysis using structural equation modeling will evaluate treatment effects, complemented by qualitative insights into implementation barriers and facilitators. Discussion: This study protocol develops and evaluates Tele-Support Psychotherapy (TSP) for youth depression in resource-limited settings, addressing mental health gaps exacerbated by COVID-19. Using user-centered design and mixed methods, it explores TSP's feasibility, adaptability, and cost-effectiveness while addressing barriers like technology literacy, laying the groundwork for accessible digital mental health solutions. Trial Registration: PACTR202201684613316.