N/A Completed N=181 Randomized Single-blind Prevention

Preventing Depression in Late Life: A Model for Low and Middle Income Countries

Depression · Anxiety

Source: ClinicalTrials.gov NCT02145429 ↗

Enrolled (actual)

181

Serious AEs

13.3%

Results posted

Jan 2019

Primary outcomePrimary: Percent of Participants Who Develop Major Depression and Anxiety Disorders — 4; 13 Participants — p=0.04

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Participants Who Develop Major Depression and Anxiety Disorders	4; 13	0.04 sig
PRIMARY General Health Questionnaire (GHQ) Scores	3.67; 5.67	<0.001 sig
SECONDARY World Health Organization Disability Assessment Schedule (WHODAS-II) Scores	16.72; 17.73	0.26

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02145429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.