Depression Clinical Trial
Official title:
Preventing Depression in Late Life: A Model for Low and Middle Income Countries
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.
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).
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