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

Etheldreda Nakimuli-Mpungu ^1* Jeremiah Mutinye Kwesiga ¹ John Mark Bwanika ² Davis Musinguzi ² Jane Iya ³ Caroline Nakanyike ³ Sabrina Bakeera ¹ Benedict Akimana ⁴ Charlotte Hawkins ⁵ Patricia Cavazos ⁶ Jean B Nachega ⁷ Edward J Mills ⁸ Seggane Musisi ¹

• ¹ Makerere University College of Health Sciences, Kampala, Uganda
• ² The Medical Concierge Group/Rocket Health Africa, Kampala, Uganda
• ³ SEEK Group Support Psychotherapy Initiative Limited, Kampala, Uganda
• ⁴ Ministry of Health, Butabika National Referral Hospital, Kampala, Uganda
• ⁵ University College London, London, England, United Kingdom
• ⁶ Washington University in St. Louis, St. Louis, Missouri, United States
• ⁷ Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, USA, Pittsburgh, Pennsylvania, United States
• ⁸ McMaster University, Hamilton, Ontario, Canada

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.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. Intentionto-treat analysis using structural equation modeling will evaluate treatment effects, complemented by qualitative insights into implementation barriers and facilitators.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.Ethical approval has been obtained from the Makerere College of Health Sciences and the Uganda National Council for Science and Technology. Findings will be disseminated through academic publications, conferences, and reports to stakeholders, ensuring accessibility to both the scientific community and mental health practitioners.Clinical Trial Registration Number: PACTR202201684613316.