SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project

Summary

Despite carrying the vast majority of the global mental disorder burden, 75% of adults with mental disorders in Low and Middle Income Countries have no access to services. This study will test strategies for integrating first and second line evidence-based depression and trauma-related disorder treatments with primary care services at a large public sector hospital and conduct robust cost and cost-benefit analyses of each treatment to produce a "menu" of cost-benefit options for personalized, integrated mental health care with corresponding effectiveness and implementation values.

Conditions

• Depression, Unipolar
• Posttraumatic Stress Disorder
• Trauma

Interventions

DRUG

Fluoxetine

Fluoxetine is a selective serotonin reuptake inhibitor that is FDA approved for the treatment of depression. Compared to placebo, fluoxetine is more likely to produce symptom response for MDD. Despite the interim development of many other antidepressants since the development of fluoxetine, it remains a first line treatment for depression.

BEHAVIORAL

Interpersonal Psychotherapy

IPT was developed in the 1980s by Gerald Klerman and Myrna Weissman to address interpersonal issues in depression. IPT is now considered evidence-based, first-line treatment for depression. IPT improves symptoms by addressing problems in social relationships. IPT is traditionally delivered as weekly one-hour sessions over 12 weeks, focused on one interpersonal problem area.

Sponsors & Collaborators

• University of Nairobi

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Kenya Medical Research Institute

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Makerere University

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Muthoni J Mathai, MDChB, MMed · University of Nairobi

• Susan M Meffert, MD, MPH · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-31

Primary Completion

2024-05-06

Completion

2024-05-06

Countries

• Kenya

Study Locations