Despite two decades of efficacy research showing that local nonspecialists can provide evidence-based care for depression and anxiety in low- and middle-income countries (LMICs), few studies have advanced to the critical next step: identifying strategies for sustainable “real world” nonspecialist treatment including 1) integration with existing healthcare platforms and 2) response to common clinical dilemmas, such as what treatment to start with and how to modify it.
Given the need to personalize treatment to achieve remission (absence of disease) and the scarcity of mental health specialists in LMICs, successful reduction of population-level disability caused by depression and anxiety requires the following:
1. Evidence-based strategies for first-line and second-line (non-remitter) treatment delivered by nonspecialists
2. Identification of patient-level moderators of treatment outcome to inform personalized, nonspecialist treatment algorithm.
The SMART DAPPER trial is composed of a Sequential, Multiple Assignment Randomized Trial (SMART) for non-specialist treatment of common mental disorders in Kenya and will leverage the Depression and Primary-Care Partnership for Effectiveness-Implementation Research Project (DAPPER).
Find more information at ClinicalTrials.Gov. The study protocol has been published.
SMART DAPPER Trial Background
The purpose of the SMART DAPPER study is to identify evidence-based strategies for first-line and second-line (non-remitter) treatment delivered by nonspecialists, including optimal choice of treatment sequences.
We will use a Sequential, Multiple Assignment Randomized Trial (SMART) design to randomize 2,710 patients from the outpatient clinics at Kisumu County Hospital (KCH) and other Kisumu County Ministry of Health facilities who have major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD). The study will consist of 12 weekly sessions of nonspecialist-delivered Interpersonal Psychotherapy (IPT) or 6 months of fluoxetine prescribed by a nurse or clinical officer.
Participants who are not in remission at the conclusion of the first phase of treatment (IPT or fluoxetine) will be re-randomized to receive the other treatment (IPT receives fluoxetine and vice versa) or to combination treatment (IPT and fluoxetine).
Kisumu County Hospital serves 10,000 primary care adult outpatients per month. Enrollment is slated to begin in mid 2020.
Key Study Objectives
- Determine the effectiveness of nonspecialist-delivered IPT, fluoxetine or the combination for MDD and PTSD.
- Identify key factors that are associated with successful remission of depression and PTSD from treatment.
- Estimate the costs and cost-benefit ratios for fluoxetine and IPT treatment of depression and PTSD.
- Determine the acceptability and feasibility of delivering SMART-DAPPER treatments by telephone.
- Determine the effect of telephone treatment delivery on retention in care.
Study Interventions
Interpersonal Psychotherapy (IPT)
This treatment will involve 12-week, diagnosis‐focused psychotherapy to help patients cope with interpersonal crises such as grief, interpersonal conflict or a role transition through building healthy social support and improving communication. Treatment may be provided in person or by telephone.
We recruited people to be IPT therapists who have strong interest in providing mental health care and an aptitude for listening and communicating effectively about emotions. The therapists have a wide range of backgrounds including healthcare workers, nutritionists, social workers, HIV testing services (HTS) counselors, anthropologists, teachers, church leaders, women’s group leaders, community leaders and HIV treatment adherence counselors. They have received a classroom-based IPT training course followed by at least four months of supervised practice cases, with ongoing onsite supervision.
Fluoxetine
A well-studied antidepressant medication called a selective serotonin reuptake inhibitor (SSRI), fluoxetine is commonly used in public-sector healthcare.
We recruited nurses and clinical officers to be fluoxetine providers and trained them on mental disorders and the use of fluoxetine to treat depression and PTSD. They received a classroom-based training course in the use of fluoxetine to treat depression and PTSD followed by at least four months of supervised practice cases, with ongoing onsite supervision.Treatment may be provided in person or by telephone.
Study Design
Approach & Philosophy
The Exploration, Preparation, Implementation and Sustainment (EPIS) model will be our primary vehicle for engaging key stakeholders to plan the proposed research, adapt/optimize depression care and identify strategies for incorporating positive findings into policy and practice. The EPIS model balances engagement of the inner context (e.g., clinic staff, patients and providers) and the outer context (e.g., local health policy and community leaders, regional stakeholders and national mental health policy experts) stakeholders. We will use this framework to inform the research and incorporate positive findings into practice.
The Implementation Resource Team (IRT) is a group of key stakeholders who were identified to facilitate the implementation and scale-up of the study findings. IRT members are involved from the beginning of the study to:
- Address challenges of translating evidenced-based practices into the broader application
- Adapt the intervention(s) to the local context to increase the likelihood of sustainability and scale-up
- Reduce the lag between development and testing of evidence-based practices and implementation
- Prioritize variables likely to play key roles in implementation efforts
- Foster partnerships between the study and local community
- Share findings with the community as they become available
The success of the research depends upon active participation by the involved communities, including local, national, and regional stakeholders. Including community members at all levels of the research process helps build trust and mutual understanding of the research and ensures that values and cultural differences are respected and incorporated into the process.
The IRT consists of a committed core membership dedicated to optimizing the interventions for effective, sustainable and scalable approaches to reducing the burden of the two most common mental disorders in East Africa: depression and trauma-related disorders.
Training for Depression & PTSD treatment
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Interpersonal Psychotherapy
- An introduction to mental disorders is provided, focused on depression and trauma and emphasizing a medical model.
- Patient-provider interactions are reviewed, including the fundamental importance of confidentiality.
- Basic tenets of psychotherapy are introduced, followed by introduction to IPT.
- Instruction is provided covering the initial, middle and concluding phases of IPT.
- The sequence of IPT work is reviewed, including tasks and techniques for each phase and session of IPT and reinforced with small-group work.
- Interested prospective IPT therapists are invited to the practice phase, in which they are closely supervised in practice cases by local supervisors and investigators who are IPT experts.
- Prospective therapists who demonstrate top scores on the IPT adherence measures are considered potential candidates for the provision of IPT to study participants, with required weekly supervision and scoring of adherence to protocol.
- The chosen nonspecialist IPT therapists discuss each IPT session with the lead IPT therapists in weekly group supervision sessions onsite in Kisumu.
Fluoxetine (providers are nurses and clinical officers who are licensed to prescribe fluoxetine in Kenya)
- An introduction to mental disorders is provided, focused on depression and trauma.
- Patient-provider interactions are reviewed, including the fundamental importance of confidentiality.
- The use of antidepressants to treat depression and PTSD is taught, focused on the role of fluoxetine.
- Candidates who demonstrate competence after training are invited to see practice cases, with close local and investigator supervision and scoring of their adherence to protocol.
- Prospective fluoxetine providers who demonstrate top scores on the fluoxetine adherence measurers are considered potential candidates for the provision of fluoxetine to study participants, with required ongoing weekly supervision and scoring of adherence to protocol.
