TY - JOUR
KW - Depression
KW - Fluoxetine
KW - implementation science
KW - Interpersonal psychotherapy (IPT)
KW - Multiple assignment randomized trial
KW - post-traumatic stress disorder (PTSD)
KW - primary care
KW - SSRI
KW - Sequential
KW - sub-Saharan Africa
KW - Trauma
AU - R. Levy
AU - M. Mathai
AU - P. Chatterjee
AU - L. Ongeri
AU - S. Njuguna
AU - D. Onyango
AU - D. Akena
AU - G. Rota
AU - A. Otieno
AU - T. C. Neylan
AU - H. Lukwata
AU - J. G. Kahn
AU - C. R. Cohen
AU - D. Bukusi
AU - G. A. Aarons
AU - R. Burger
AU - K. Blum
AU - I. Nahum-Shani
AU - C. E. McCulloch
AU - S. M. Meffert
A1 - 
AB - BACKGROUND: Mental 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/DESIGN: We 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. DISCUSSION: 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 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 REGISTRATION: ClinicalTrials.gov NCT03466346, registered March 15, 2018.
AD - Medical School, University of California, San Francisco, CA, USA.; Department of Psychiatry, University of Nairobi, Nairobi, Kenya.; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.; Kenya Medical Research Institute (KEMRI), Nairobi, Kenya.; Director of Mental Health, Kenyan Ministry of Health, Nairobi, Kenya.; Kisumu County, Ministry of Health, Kisumu, Kenya.; Department of Psychiatry, Makerere University, Kampala, Uganda.; University of Nairobi, Nairobi, Kenya.; University of Nairobi, Nairobi, Kenya.; Departments of Psychiatry and Neurology, University of California, San Francisco, CA, USA.; Division of Mental Health and Control of Substance Abuse, Ministry of Health -, Kampala, Uganda.; Department of Epidemiology and Biostatistics, Institute for Health Policy Studies, University of California, San Francisco, CA, USA.; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, UC Global Health Institute, San Francisco, CA, USA.; Department of Psychiatry, Kenyatta National Hospital, University of Nairobi, Nairobi, Kenya.; Department of Psychiatry, University of California, San Diego, CA, USA.; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA.; Department of Psychiatry, University of California, San Francisco, CA, USA.; Institute for Social Research, University of Michigan, Ann Arbor, Michigan, USA.; Division of Mental Health and Control of Substance Abuse, Ministry of Health -, Kampala, Uganda.; Department of Psychiatry, University of California, San Francisco, CA, USA. Susan.Meffert@ucsf.edu.
BT - BMC psychiatry
C5 - Education & Workforce; Healthcare Disparities
CP - 1
CY - England
DO - 10.1186/s12888-019-2395-x
IS - 1
JF - BMC psychiatry
LA - eng
M1 - Journal Article
N2 - BACKGROUND: Mental 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/DESIGN: We 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. DISCUSSION: 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 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 REGISTRATION: ClinicalTrials.gov NCT03466346, registered March 15, 2018.
PP - England
PY - 2019
SN - 1471-244X; 1471-244X
SP - 424
T1 - Implementation research for public sector mental health care scale-up (SMART-DAPPER) … in Kenya
T2 - BMC psychiatry
TI - Implementation research for public sector mental health care scale-up (SMART-DAPPER) … in Kenya
U1 - Education & Workforce; Healthcare Disparities
U2 - 31883526
U3 - 10.1186/s12888-019-2395-x
VL - 19
VO - 1471-244X; 1471-244X
Y1 - 2019
Y2 - Dec 28
ER -