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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02145429
Enrollment
181
Registered
2014-05-22
Start date
2013-09-30
Completion date
2018-11-07
Last updated
2019-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder, Depression

Keywords

Prevention of depression and anxiety disorder, Depression 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).

Interventions

BEHAVIORALProblem Solving therapy and Brief Behavioral Treatment of Insomnia

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Goa Medical College
CollaboratorOTHER
Sangath
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent of Participants Who Develop Major Depression and Anxiety DisordersOne yearCumulative incidence of episodes of major depression and anxiety disorders over a 12-month period measured by MINI
General Health Questionnaire (GHQ) ScoresOne yearLevels 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

Secondary

MeasureTime frameDescription
World Health Organization Disability Assessment Schedule (WHODAS-II) ScoresOne yearAssessment instrument for health and disability or functional status. Scores on the World Health Organization Disability Assessment Schedule (WHODAS 2.0) range from 12 to 60; a higher score indicated greater disability.

Countries

India

Participant flow

Recruitment details

Because enrollment exceeded expectations, we were able to increase sample size from the original n proposed (120) to 181, thereby allowing us to carry out a fully powered confirmatory RCT. We obtained NIMH permission to change from an intervention development study to an RCT

Participants by arm

ArmCount
Problem Solving Therapy + Behavioral Treatment of Insomnia
Problem Solving Therapy + Brief Behavioral Treatment of Insomnia as needed Problem Solving therapy and Brief Behavioral Treatment of Insomnia: 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.
91
Enhanced Usual Care
Care as usual with scheduled assessments of clinical status
90
Total181

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath45
Overall StudyLost to Follow-up43
Overall StudyWithdrawal by Subject83

Baseline characteristics

CharacteristicEnhanced Usual CareTotalProblem Solving Therapy + Behavioral Treatment of Insomnia
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
90 Participants181 Participants91 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous69.7 years
STANDARD_DEVIATION 7.3
69.6 years
STANDARD_DEVIATION 7.2
69.6 years
STANDARD_DEVIATION 7.1
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
90 Participants181 Participants91 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
India
90 Participants181 Participants91 Participants
Sex: Female, Male
Female
57 Participants114 Participants57 Participants
Sex: Female, Male
Male
33 Participants67 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 915 / 90
other
Total, other adverse events
0 / 910 / 90
serious
Total, serious adverse events
19 / 915 / 90

Outcome results

Primary

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

Time frame: One year

ArmMeasureValue (MEAN)Dispersion
Problem Solving Therapy + Behavioral Treatment of InsomniaGeneral Health Questionnaire (GHQ) Scores3.67 score on a scaleStandard Deviation 2.67
Enhanced Usual CareGeneral Health Questionnaire (GHQ) Scores5.67 score on a scaleStandard Deviation 3.19
p-value: <0.00195% CI: [-2.03, -0.31]Mixed Models Analysis
Primary

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

Time frame: One year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Problem Solving Therapy + Behavioral Treatment of InsomniaPercent of Participants Who Develop Major Depression and Anxiety Disorders4 Participants
Enhanced Usual CarePercent of Participants Who Develop Major Depression and Anxiety Disorders13 Participants
p-value: 0.0495% CI: [0.1, 0.98]Log Rank
Secondary

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

Assessment instrument for health and disability or functional status. Scores on the World Health Organization Disability Assessment Schedule (WHODAS 2.0) range from 12 to 60; a higher score indicated greater disability.

Time frame: One year

ArmMeasureValue (MEAN)Dispersion
Problem Solving Therapy + Behavioral Treatment of InsomniaWorld Health Organization Disability Assessment Schedule (WHODAS-II) Scores16.72 score on a scaleStandard Deviation 5.71
Enhanced Usual CareWorld Health Organization Disability Assessment Schedule (WHODAS-II) Scores17.73 score on a scaleStandard Deviation 6.27
p-value: 0.2695% CI: [-1.89, 1.62]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026