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

NCT02145429 | Completed Results DMC

• 1 other identifier: 1R34MH096997-01A1
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety Disorder

Keywords

Prevention of depression and anxiety disorder; Depression Prevention

Outcome Measures

Primary Outcomes (2)

• Percent of Participants Who Develop Major Depression and Anxiety Disorders

  Cumulative incidence of episodes of major depression and anxiety disorders over a 12-month period measured by MINI

  One year

• General Health Questionnaire (GHQ) Scores

  Levels of depressive and anxiety symptoms. Scores on the General Health Questionnaire (GHQ-12) range from 0 to 12; a higher score indicated greater symptoms for depression and anxiety

  One year

Secondary Outcomes (1)

• World Health Organization Disability Assessment Schedule (WHODAS-II) Scores

  One year

Study Arms (2)

problem solving therapy + Behavioral Treatment of Insomnia

EXPERIMENTAL

Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed

Behavioral: Problem Solving therapy and Brief Behavioral Treatment of Insomnia

Enhanced Usual Care

NO INTERVENTION

Care as usual with scheduled assessments of clinical status

Interventions

Problem Solving therapy and Brief Behavioral Treatment of Insomnia BEHAVIORAL

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.

problem solving therapy + Behavioral Treatment of Insomnia

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• Goa Medical College: collaborator
• Sangath: collaborator

Study Sites (1)

Goa Medical College

Bambolim, Goa, India

Location

Related Publications (1)

• 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.

  PMID: 30422259 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Charles F. Reynolds, MD
• Organization: University of Pittsburgh

reynoldscf@upmc.edu

(412) 246-6414

Study Officials

• Charles F Reynolds, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Amit Dias, MD

  Sangath and Goa College of Medicine

  PRINCIPAL INVESTIGATOR

• Vikram Patel, MD, PHD

  Sangath

  PRINCIPAL INVESTIGATOR

• Alex Cohen, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Geriatric Psychiatry

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: September 1, 2013
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: January 24, 2019
• Results First Posted: January 24, 2019

Record last verified: 2019-01

Locations

IN (1)