CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
Problem Solving therapy and Brief Behavioral Treatment of Insomniabehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02145429
NCT02145429N/ACompleted

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

University of Pittsburgh·interventional·Posted May 22, 2014·Updated Jan 24, 2019

In Brief

A clinical study evaluating Problem Solving therapy and Brief Behavioral Treatment of Insomnia for Depression and Anxiety Disorder. Completed, enrolled 181 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 22, 2014
Enrollment StartSep 1, 2013
Primary CompletionNov 7, 2018
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 12.1 years ago

Interventions

Problem Solving therapy and Brief Behavioral Treatment of Insomniabehavioral

Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need. Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services.