The Health and Social Consequences of Depression Among the Elderly

NCT ID: NCT05856552

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5370 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2028-12-31

Brief Summary

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Mental illnesses often go undiagnosed or untreated in low-income settings. Mental health care may be especially important for the elderly - events in the lives of the elderly, like illnesses or deaths of peers, may put these individuals at high risk of mental illness. The study will constitute a randomized controlled trial aimed at reducing depression among elderly women. Through two interventions, the investigators will aim to improve women elder's outlook on life and relationships through cognitive behavioral therapy (CBT) and facilitated group activities. There will be a total of four treatment arms: one for CBT during home visits, one for facilitated group activities, one for both, and a control group receiving neither the CBT nor facilitated group activities. All activities will be delivered by lay government community volunteers. Randomization for group activities will be at the village level, and randomization for CBT will be at the individual-level within each village. Investigators will track outcomes of the elderly at two points in time: immediately after the main 12-week intervention period and 6 months after the main intervention period.

Detailed Description

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Conditions

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Depression Functional Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT home visits

Community resource persons will visit the elderly women once per week to deliver cognitive behavioral therapy for six weeks, followed by 3 monthly boosters. For half the experimental sample, the boosters will be an ongoing monthly intervention beyond the initial 6-week period.

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

Cognitive behavioral therapy delivered by community resource persons via home visits.

CBT home visits and group activities

Community resource persons will visit the elderly women once per week to deliver cognitive behavioral therapy for six weeks, followed by 3 monthly boosters. The elderly women will also be invited to join weekly hour-long group activities for 12 weeks. Group activities will be administered by community resource persons in community spaces. For half of the experimental sample, the group activities will be an ongoing weekly intervention beyond the initial 12-week period, and the CBT booster sessions will be administered monthly after the initial 6-week period.

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

Cognitive behavioral therapy delivered by community resource persons via home visits.

Group Activities

Intervention Type BEHAVIORAL

Weekly hour-long group activities delivered by community resource persons in community spaces.

Control

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Group activities

The elderly women will be invited to join weekly hour-long group activities for 12 weeks. Group activities will be administered by community resource persons in community spaces. For half of the experimental sample, the group activities will be an ongoing weekly intervention beyond the initial 12-week period.

Group Type EXPERIMENTAL

Group Activities

Intervention Type BEHAVIORAL

Weekly hour-long group activities delivered by community resource persons in community spaces.

Interventions

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CBT

Cognitive behavioral therapy delivered by community resource persons via home visits.

Intervention Type BEHAVIORAL

Group Activities

Weekly hour-long group activities delivered by community resource persons in community spaces.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At least 55 years of age
* Women

Exclusion Criteria

* Those with hearing, speech or mental impairment
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Bureau of Economic Research, Inc.

OTHER

Sponsor Role lead

Abdul Latif Jameel Poverty Action Lab

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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JPAL SA at IFMR

Chennai, Tamil Nadu, India

Site Status RECRUITING

JPAL SA at IFMR

Chennai, Tamil Nadu, India

Site Status ACTIVE_NOT_RECRUITING

Countries

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India

Central Contacts

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Esther Duflo, PhD

Role: CONTACT

(617) 324-4867

Facility Contacts

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Shrddha Rajesh (Senior Research Associate at J-PAL)

Role: primary

+91 96770 25388

Other Identifiers

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23003

Identifier Type: -

Identifier Source: org_study_id

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