SMART DAPPER is an implementation science study responding to mental health treatment gaps for depression and trauma-related disorders in Sub-Saharan Africa (SSA). We report on patient experiences in a study using a Sequential, Multiple Assignment Randomized Trial (SMART) design to test first and second line non-specialist treatment using psychotherapy (Interpersonal Psychotherapy [IPT] or medication (fluoxetine [FLX]), integrated within public sector primary care in western Kenya. An embedded qualitative study conducted in-depth interviews (n = 17) and three (n = 3) focus group discussions with participants (May to October 2021). Audio-recorded interviews were transcribed and translated into English; we deductively and inductively analyzed transcripts guided by grounded theoretical approaches and content analysis. We drew on the health belief model and socio-ecological framework to present findings, including perceived severity (motivations for taking part in the intervention), impacts of the intervention at the individual, interpersonal, and community and health systems levels as well as barriers and facilitators. Participants discussed family and marital conflict, loss of a child, loss of income or a job, and traumatic events such as a death or illness. Impacts at the individual level included reduced headaches, improved appetite and weight management, increased energy, improved sleep, better self-efficacy, and improved concentration, which was reported to lead to increased economic opportunities. At the interpersonal level, participants noted a reduction in conflict, better conflict management and resolution, increased harmony with family and community members, and improved relationships with their partners and children. Perceived challenges included balancing the intervention with livelihoods, preference for traditional medicines, actual or anticipated side effects with medication (FLX), mental health stigma, major life events, and perceived inadequate counseling and challenges with providers. The findings demonstrate the potential of the SMART DAPPER intervention for depression and trauma-related disorder treatments and underscore the challenges and barriers that must be addressed when scaling similar interventions. Trial registration: ClinicalTrials.gov identifier: NCT03466346.

Background

Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Our research team has worked in western Kenya for nearly ten years. Primary care populations in Kenya have high prevalence of Major Depressive Disorder (MDD) and Posttraumatic Stress Disorder (PTSD). To address these treatment needs with a sustainable, scalable mental health care strategy, we are partnering with local and national mental health stakeholders in Kenya and Uganda to identify 1) evidence-based strategies for first-line and second-line treatment delivered by non-specialists integrated with primary care, 2) investigate presumed mediators of treatment outcome and 3) determine patient-level moderators of treatment effect to inform personalized, resource-efficient, non-specialist treatments and sequencing, with costing analyses. Our implementation approach is guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.

Methods/design

We will use a Sequential, Multiple Assignment Randomized Trial (SMART) to randomize 2710 patients from the outpatient clinics at Kisumu County Hospital (KCH) who have MDD, PTSD or both to either 12 weekly sessions of non-specialist-delivered Interpersonal Psychotherapy (IPT) or to 6 months of fluoxetine prescribed by a nurse or clinical officer. Participants who are not in remission at the conclusion of treatment will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine). The SMART-DAPPER Implementation Resource Team, (IRT) will drive the application of the EPIS model and adaptations during the course of the study to optimize the relevance of the data for generalizability and scale -up.

Discussion

The results of this research will be significant in three ways: 1) they will determine the effectiveness of non-specialist delivered first- and second-line treatment for MDD and/or PTSD, 2) they will investigate key mechanisms of action for each treatment and 3) they will produce tailored adaptive treatment strategies essential for optimal sequencing of treatment for MDD and/or PTSD in low resource settings with associated cost information - a critical gap for addressing a leading global cause of disability.

Trial registration

ClinicalTrials.gov NCT03466346, registered March 15, 2018.