Summary

for people ages 18 years and up (full criteria)
study started
estimated completion:

Description

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 evidence-based depression 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 integrated depression care with corresponding effectiveness and implementation values. The project is relevant to the mission of the National Institutes of Mental Health because it addresses mental health care delivery and related health economics at the individual, clinical and systems levels.

Details

Dominated by depression, mental disorders are a leading cause of global disability. Most of the disease burden is in Low and Middle Income Countries (LMICs), where 75% of adults with mental disorders have no service access. Despite nearly 15 years of efficacy studies showing that local non-specialists can provide evidence-based care for depression in LMICs, few studies have advanced to implementation research. As emphasized by a recent World Health Organization (WHO) initiative, integration of depression treatment into existing systems of care is critical to achieving public health impact.

The research team has worked in western Kenya for 5 years with a UCSF-Kenya collaboration that supports integrated HIV services at over 70 primary healthcare facilities in Kisumu County (Family AIDS Care and Education Services [FACES]). With high prevalence of Major Depressive Disorder (MDD) in Kenyan primary care populations (26.3%, 3-5 times higher than in the U.S.), treatment for depression is a top concern for Kenyan mental health leaders. Kenyan leaders recently launched a government-funded initiative to scale-up treatment for mental disorders in primary healthcare, prioritizing depression. Yet, they lack an evidence base for the two essential treatments -psychotherapy and second generation antidepressants—without which Kenyan care scale-up will fall short of its potential. The proposed research responds to this need.

The investigators will partner with local and national mental health stakeholders in Kenya to evaluate: (1) non-specialist delivery of evidence-based depression treatment integrated within existing healthcare centers in regards to clinical effectiveness and implementation parameters; including (2) costs and cost-benefit ratios for depression care. Given that evidence-based psychotherapy and second-generation antidepressants are the two leading first-line treatments for depression and are feasible to deliver in Kenya, the investigators' goal is to test an implementation strategy for improving equitable access to these treatments by integrating them with primary care. The study uses an effectiveness-implementation hybrid design type I to assess outcomes of non-specialist delivered Interpersonal Psychotherapy (IPT) compared to fluoxetine, including assessment of the service delivery mechanism.

The study's approach differs from most prior work in the field because it uses an effectiveness-implementation design, compares outcomes for IPT versus second generation antidepressant, integrates depression treatment into primary care, and analyses depression care costs and cost-benefit ratios for each treatment arm. The results of the proposed research will be significant in two ways: (1) they will produce a scalable strategy for delivering depression treatments in sub-Saharan Africa using non-specialists integrated within existing primary care structures and (2) they will produce a policy maker "menu" of short and long-term cost-benefit options for integrated depression care with corresponding effectiveness and implementation values.

Keywords

Depression, Unipolar Depression Depressive Disorder Fluoxetine Serotonin Uptake Inhibitors Interpersonal Psychotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Kisumu County Hospital (KCH) adult primary care outpatient clinic attendees who screen positive for MDD on the Mini International Neuropsychiatric Interview (MINI);
  2. Ability to attend weekly IPT sessions/fluoxetine monitoring; (3) 18 years or older

You CAN'T join if...

  1. Cognitive dysfunction compromising ability to participate in IPT or accurately take fluoxetine (lack of orientation to person, place, time and situation)
  2. acute suicidality (moderate or high score on the MINIsuicidality module) requiring higher level of care
  3. drug/alcohol use disorders requiring substance use treatment (AUDIT score of 8 or higher, DAST score of 3 or higher)
  4. history of mania or requiring treatment for hypomania (positive score on MINI mania/hypomania module)
  5. 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).

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03466346
Study Type
Interventional
Last Updated