Clinical trial NCT02145429: Preventing Depression in Late Life: A Model for Low and Middle Income Countries
Official title: Preventing Depression in Late Life: A Model for Low and Middle Income Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety Disorder
Keywords: Prevention of depression and anxiety disorder
Depression Prevention
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Goa Medical College
name: Sangath
First posted: 2014-05-22
Enrollment: 181
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being conducted in GOA India. The study addresses specific issues of depression prevention in older adults living in low- and middle income countries (LMICs), by developing risk-reduction strategies through the use of lay health counselors. We will be training Lay Health Counselors (LHC's) to deliver simple behaviorally oriented interventions, designed to enhance the ability to relax, to improve active coping via better problem solving, and to increase protective factors such as good quality sleep. Lay Health Counselors are inhabitants of Goa.

The aim of phase 1 is to create a depression and anxiety prevention intervention for use by lay health counselors. We will test the feasibility and acceptability of Problem Solving Therapy for Primary Care (PST-PC) and Brief Behavioral Treatment for Insomnia (BBTI). The products of phase 1 will be a prevention and counseling manual to standardize the implementation of the interventions for further testing in a randomized prevention trial (Specific Aim 2) and the adaptation of PST-PC and BBTI for the Indian population.

In Phase 2, we will: gather data on the feasibility of identifying, enrolling, randomizing and retaining participants; implement the experimental intervention and enhanced usual care; identify "real world", barriers and develop strategies for addressing them; and assess the fidelity of the interventions.

Detailed description: Prevention of common mental disorders in older adults (major depression and anxiety disorders) in Low and Middle Income Countries (LMICs) is a major challenge in global mental health research. The public health imperative for devising strategies to prevent late life depression and anxiety in LMICs includes the rapid demographic transition and aging in countries like India, increased exposure of older adults to risk factors for depression (disability, depletion of economic and social resources, bereavement, care giving, and chronic insomnia), and workforce issues (such as a dearth of mental health specialists). The dearth of specialist resources, together with the limited ability of current depression treatments to avert years lived with disability, underscores the need for preventive interventions that can be delivered by lay health workers in non-health care or primary care settings. Such development could also benefit policy and practice in the US by clarifying appropriate roles for lay and non-specialist workers in depression and anxiety prevention for populations with few mental health resources. We propose to build upon the MANAS trial conducted in Goa, India. Given the shortage of mental health specialists in Low and Middle Income Countries (LMICs), MANAS (which means "project to promote mental health" in the Konkani language) employed the strategy of task-shifting, that is, the rational redistribution of tasks among health workforce teams to make more efficient use of lay human resources for health. MANAS demonstrated that the use of lay health counselors (LHCs), as part of a collaborative stepped care intervention, increases rates of recovery from common mental disorders (depression and anxiety) in public primary care facilities. In addition, preliminary evidence indicated that the MANAS model of using Lay Health Counselors in a stepped-care collaborative intervention may also reduce the incidence of common mental disorders in those who initially present with subthreshold (subsyndromal) depressive and anxiety symptoms. We propose to investigate translation of depression and anxiety prevention strategies to LMICs through non-specialist delivery systems. The goal of this study is to develop and pilot test in Goa, India a Lay Health Counselor-led depression and anxiety disorder prevention strategy, building upon the experience of the MANAS treatment trial called the DIL (Depression in Late Life) intervention.

Specific Aim (1) formative research (months 1 - 12): following Medical Research Council Guidelines for the development of complex interventions, we will create and standardize a MANAS-derived depression and anxiety prevention intervention (DIL Intervention) for use by lay health counselors (LHCs) in primary care clinics in Goa. We will develop an intervention manual based on the original MANAS trial and best practices for depression and anxiety prevention from the global literature. Via systematic study of an uncontrolled case series (enrolling 20 subjects), we will test the feasibility and acceptability of DIL Intervention. The DIL Intervention will comprise psychoeducational interventions delivered by Lay Health Counselors and previously shown to have prevention, such as Problem Solving Therapy for Primary Care (PST-PC) and Brief Behavioral Treatment for Insomnia (BBTI). The products of Specific Aim (1) will be a prevention manual to standardize the implementation of DIL Intervention for further testing in a pilot randomized prevention trial (Specific Aim 2), together with recruitment and assessment protocols and a randomization procedure.

Specific Aim (2) pilot randomized prevention trial (months 13 - 36): Via the use of a pilot randomized prevention trial (DIL Intervention) we will: gather data on the feasibility of identifying, enrolling, randomizing and retaining participants; implement the experimental intervention and enhanced usual care; identify "real world", barriers and develop strategies for addressing them; and assess the fidelity of the DIL implementation. As recommended in the R34 program announcement (PAR-09-173), we will collect measures of feasibility, acceptability, tolerability, and safety, rather than conducting formal tests of outcome or attempting to obtain an estimate of an effect size (because estimates are likely to be inflated and unstable.) These data will be critical to a subsequent confirmatory randomized depression prevention trial based in Goa and to our long-term goal of scalable depression prevention in Low and Middle Income Countries (LMICs).

Eligibility criteria: Inclusion Criteria:

* Patient at the participating primary care centers
* age 60 and older
* GHQ scores 4 or above
* Hindi MMSE scores 24 or higher
* no episodes of major depression or anxiety disorder within the past 12 months
* no current antidepressant pharmacotherapy

Exclusion Criteria:

* episode of major depression or anxiety disorder within the past 12 months
* current antidepressant pharmacotherapy
* younger than age 60
* Hindi MMSE scores less than 24
* GHQ scores less than 4

Primary outcomes:
measure: Percent of Participants Who Develop Major Depression and Anxiety Disorders
timeFrame: One year
measure: General Health Questionnaire (GHQ) Scores
timeFrame: One year
Secondary outcomes:
measure: World Health Organization Disability Assessment Schedule (WHODAS-II) Scores
timeFrame: One year
Other outcomes:
Locations:
city: Bambolim
country: India
facility: Goa Medical College
state: Goa
Study officials:
affiliation: University of Pittsburgh
name: Charles F Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sangath and Goa College of Medicine
name: Amit Dias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sangath
name: Vikram Patel, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Alex Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dias A, Azariah F, Anderson SJ, Sequeira M, Cohen A, Morse JQ, Cuijpers P, Patel V, Reynolds CF 3rd. Effect of a Lay Counselor Intervention on Prevention of Major Depression in Older Adults Living in Low- and Middle-Income Countries: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Jan 1;76(1):13-20. doi: 10.1001/jamapsychiatry.2018.3048.