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

NCT03466346 | Completed Results DMC

• 3 other identifiers: 1R01MH115512 1R01MH113722-01A11R01MH1155121R01MH113722-01A1
• Study Type: interventional
• Target: 2,162
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Major Depression at End of Treatment

  Number of Participants with Major Depression. The Beck Depression Inventory-Second Edition (BDI-II) was used and a score of 19 or greater was defined as positive for major depression. BDI-II score below 19 is defined as negative for major depression. Scores range from 0 to 63 with higher total scores indicating more severe depressive symptoms.

  End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)

• Number of Participants With PTSD

  Number of Participants with PTSD. The PTSD Checklist for DSM-5 (PCL-5) was used and score of 23 or greater is defined as positive for PTSD. PCL-5 score below 23 is defined as negative for PTSD. Score range from 0 to 80 with higher total scores indicating more severe PTSD symptoms.

  End of 1st line Treatment (up to month 6) and end of 2nd line Treatment (up to month 12)

Study Arms (5)

Interpersonal psychotherapy

ACTIVE COMPARATOR

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.

Behavioral: Interpersonal Psychotherapy

fluoxetine

ACTIVE COMPARATOR

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.

Drug: Fluoxetine

Fluoxetine after IPT

ACTIVE COMPARATOR

participants who do not remit from MDD and PTSD after treatment with IPT may be randomized to fluoxetine.

Drug: Fluoxetine

IPT after fluoxetine

ACTIVE COMPARATOR

participants who do not remit from MDD and PTSD after treatment with fluoxetine may be randomized to IPT.

Behavioral: Interpersonal Psychotherapy

IPT + fluoxetine

ACTIVE COMPARATOR

participants who do not remit from MDD and PTSD after treatment with fluoxetine may be randomized to IPT + fluoxetine.

Drug: Fluoxetine; Behavioral: Interpersonal Psychotherapy

Interventions

Fluoxetine DRUG

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.

Fluoxetine after IPT; IPT + fluoxetine; fluoxetine

Interpersonal Psychotherapy BEHAVIORAL

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.

Also known as: IPT

IPT + fluoxetine; IPT after fluoxetine; Interpersonal psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Nairobi: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Kenya Medical Research Institute: collaborator
• University of California, San Diego: collaborator
• Makerere University: collaborator

Study Sites (3)

Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)

Kisumu, Kenya

Location

Kisumu County Hospital

Kisumu, Kenya

Location

Lumumba Health Center

Kisumu, Kenya

Location

Related Publications (6)

• Mwai D, Meffert SM, Olwanda EE, Mathai MA, Ongeri L, Burger RL, Mbwayo A, Rota G, Otieno A, Cohen CR, Bukusi D, Aarons GA, Neylan TC, McCulloch CE, Jin C, Akena D, Kahonge S, Kahn JG. Productivity benefits of treatment of depression and post-traumatic stress disorder in Kenya. BMJ Glob Health. 2025 Nov 3;10(11):e018204. doi: 10.1136/bmjgh-2024-018204.

  PMID: 41184028 DERIVED

• Burger RL, Meffert SM meffert, Ongeri L, Wangia J, Wambura R, Ajore P, Rota G, Otieno A, Obura RR, Muchembre P, Bukusi D, Mbwayo A, Neylan TC, Akena D, Jin C, McCulloch C, Mathai MA. Factors associated with fluoxetine adherence among outpatients with common mental disorders in Western Kenya. BMJ Glob Health. 2025 Aug 25;10(8):e017929. doi: 10.1136/bmjgh-2024-017929.

  PMID: 40854809 DERIVED

• Olwanda E, Mwai D, Mathai M, Burger R, Ongeri L, Bukusi D, Mbwayo A, Rota G, Otieno A, Rota R, Meffert S, Kahn JG. Cost-Benefit Analysis of Interpersonal Therapy and Fluoxetine for Treating Depression and PTSD in Primary Care Settings in Kenya. Res Sq [Preprint]. 2025 Jul 28:rs.3.rs-6977800. doi: 10.21203/rs.3.rs-6977800/v1.

  PMID: 40766223 DERIVED

• Meffert S, Mathai M, Neylan T, Mwai D, Onyango DO, Rota G, Otieno A, Obura RR, Wangia J, Opiyo E, Muchembre P, Oluoch D, Wambura R, Mbwayo A, Kahn JG, Cohen CR, Bukusi D, Aarons GA, Burger RL, Jin C, McCulloch C, Kahonge S, Ongeri L. Preference of mHealth versus in-person treatment for depression and post-traumatic stress disorder in Kenya: demographic and clinical characteristics. BMJ Open. 2024 Nov 18;14(11):e083094. doi: 10.1136/bmjopen-2023-083094.

  PMID: 39557549 DERIVED

• Getahun M, Mathai MA, Rota G, Allen A, Burger RL, Opiyo E, Oluoch D, Wangia J, Wambura R, Mbwayo A, Muchembre P, Obura RR, Neylan TC, Aarons GA, Ongeri L, Meffert SM. "The peace that I wanted, I got": Qualitative insights from patient experiences of SMART DAPPER interventions for major depression and traumatic stress disorders in Kenya. PLOS Glob Public Health. 2024 Sep 5;4(9):e0002685. doi: 10.1371/journal.pgph.0002685. eCollection 2024.

  PMID: 39236052 DERIVED

• Levy R, Mathai M, Chatterjee P, Ongeri L, Njuguna S, Onyango D, Akena D, Rota G, Otieno A, Neylan TC, Lukwata H, Kahn JG, Cohen CR, Bukusi D, Aarons GA, Burger R, Blum K, Nahum-Shani I, McCulloch CE, Meffert SM. 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. BMC Psychiatry. 2019 Dec 28;19(1):424. doi: 10.1186/s12888-019-2395-x.

  PMID: 31883526 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Fluoxetine; Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Susan Meffert MD, MPH; Professor of Psychiatry; MPI
• Organization: University of California San Francisco

susan.meffert@ucsf.edu

4158765455

Study Officials

• Muthoni J Mathai, MDChB, MMed

  University of Nairobi

  PRINCIPAL INVESTIGATOR

• Susan M Meffert, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: participants will be evaluated by an outcomes assessor that is not aware of which treatment the participant is receiving. This will be achieved by keeping the randomization key locked and accessible only to the study coordinator and investigators. Participants who are scheduled for assessments will be reminded not to spontaneously disclose their treatment modality to the outcomes assessor.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: fluoxetine versus interpersonal psychotherapy (IPT) for treatment of Major Depressive Disorder (MDD) and/or Posttraumatic Stress Disorder (PTSD)

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 15, 2018
• Study Start: August 31, 2020
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be made available to the NIMH data archive as soon as it is verified as clean and complete, with at least annual updates throughout the duration of the study. Data will be be available indefinitely or for as long as the NIMH repositories supports the electronic data storage.
• Access Criteria: The investigative team and our NIMH and GACD partners will review requests for data. Evaluation will include scientific merit of the proposal, overlap versus building upon the study goals.

Locations

KE (3)