N/A
N=2,162
SMART-DAPPER: Leveraging the Depression And Primary-care Partnership for Effectiveness-implementation Research Project
Depression, Unipolar · Posttraumatic Stress Disorder · Trauma
Bottom Line
View on ClinicalTrials.gov: NCT03466346 ↗Enrolled (actual)
2,162
Serious AEs
4.1%
Results posted
Dec 2025
Primary outcome: Primary: Number of Participants With Major Depression at End of Treatment — 127; 89; 6; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluoxetine (Drug); Interpersonal Psychotherapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Depression at End of Treatment |
127; 89; 6; 11; 11 | — |
| PRIMARY Number of Participants With PTSD |
173; 108; 10; 14; 20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Kisumu County Hospital (KCH) adult primary care outpatient clinic attendees who screen positive for depression and/or PTSD
- Ability to attend weekly IPT sessions/fluoxetine monitoring; (3) 18 years or older
Exclusion Criteria
- Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation)
- acute suicidality requiring higher level of care
- drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher, DAST score of 3 or higher)
- history of mania or requiring treatment for hypomania
- Outside mental health treatment during the study treatment phases (any mental health treatment is allowed during follow-up phases and is recorded by study team).
Data sourced from ClinicalTrials.gov (NCT03466346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.