Implementation research for public sector mental health care scale-up (SMART-DAPPER): a sequential multiple, assignment randomized trial (SMART) of non-specialist-delivered psychotherapy and/or medication for major depressive disorder and posttraumatic stress disorder (DAPPER) integrated with outpatient care clinics at a county hospital in Kenya

Rachel Levy,Linnet Ongeri,Dickens Onyango,Kelly Blum,Purba Chatterjee,Dickens Akena,Hafsa Lukwata,Ray E Burger ,David Bukusi,Charles E Mcculloch,Simon Njuguna,Thomas C Neylan,James G Kahn,Gregory A Aarons,Craig R Cohen,Ammon Otieno,Muthoni Mathai,Grace Rota,Inbal Nahum‐Shani ,Susan M Meffert

doi:10.1186/s12888-019-2395-x

Abstract

BackgroundMental 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/designWe 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.DiscussionThe 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 registrationClinicalTrials.govNCT03466346, registered March 15, 2018.

Highlights

Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety
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 Major Depressive Disorder (MDD) and/or Posttraumatic Stress Disorder (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
Despite nearly 15 years of efficacy research showing that local nonspecialists can provide evidence-based care for depression and anxiety in Low and Middle-Income (LMIC) [5,6,7], few studies have advanced to the critical step and morbidity from mental disorders continues to escalate [8,9,10,11]

Summary

Introduction

Mental disorders are a leading cause of global disability, driven primarily by depression and anxiety. Despite nearly 15 years of efficacy research showing that local nonspecialists can provide evidence-based care for depression and anxiety in LMICs [5,6,7], few studies have advanced to the critical step and morbidity from mental disorders continues to escalate [8,9,10,11]. With high prevalence of Major Depressive (MDD) (26% [13]) and Posttraumatic Stress Disorder (PTSD) (35%( [14)]) in primary care populations, treatment for depression and PTSD are leading concerns for Kenyan mental health policy makers. Kenyan healthcare providers and policy-makers launched a government-funded initiative to scale-up treatment for mental disorders in primary healthcare [15] They lack an evidence base to guide programs for two essential treatments –psychotherapy and second generation antidepressants [16]— without which Kenyan care scale-up will fall short of its potential [17, 18].

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