The Health and Social Consequences of Depression Among the Elderly

NCT05856552 | Recruiting

• 1 other identifier: 23003
• Study Type: interventional
• Target: 5,370
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression; Functional Impairment

Keywords

Elderly; India; CBT; Group activities; Depression

Outcome Measures

Primary Outcomes (4)

• Depression Score

  The geriatric depression scale short form (GDS-15) is used. Participants are asked 15 yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, are in good spirits most of the time, are afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have more problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions (scale of 0-15) with answers coded such as 1 indicates a depressive symptom for that question and 0 otherwise.

  Assessed at 0 months after the intervention

• Depression Score

  The geriatric depression scale short form (GDS-15) is used. Participants are asked 15 yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, are in good spirits most of the time, are afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have more problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions (scale of 0-15) with answers coded such as 1 indicates a depressive symptom for that question and 0 otherwise.

  Assessed at 6 months after the intervention

• Difficulty in performing daily activities/Functional impairment score

  The 12-item WHO Disability Assessment Schedule 2.0 questionnaire is used. Participants will be asked the level of difficulty they have in doing each of the following tasks in the past 30 days due to health conditions: standing for long periods such as 30 minutes, walking a long distance (such as 1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household responsibilities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.

  Assessed at 0 months after the intervention

• Difficulty in performing daily activities/Functional impairment score

  The 12-item WHO Disability Assessment Schedule 2.0 questionnaire is used. Participants will be asked the level of difficulty they have in doing each of the following tasks in the past 30 days due to health conditions: standing for long periods such as 30 minutes, walking a long distance (such as 1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household responsibilities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.

  Assessed at 6 months after the intervention

Secondary Outcomes (11)

• Loneliness/Social Connectedness

  Assessed at 0 months after the intervention

• Loneliness/Social Connectedness

  Assessed at 6 months after the intervention

• Cognitive function

  Assessed at 0 months after the intervention

• Cognitive function

  Assessed at 6 months after the intervention

• Objective Measures of Sleep

  Assessed at 0 months after the intervention

Other Outcomes (19)

• Self-reported Measures of Sleep

  Assessed at 0 months after the intervention

• Self-reported Measures of Sleep

  Assessed at 6 months after the intervention

• Demand for Intervention Activities

  Assessed at 0 months after the intervention

Study Arms (4)

CBT home visits

EXPERIMENTAL

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.

Behavioral: CBT

CBT home visits and group activities

EXPERIMENTAL

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.

Behavioral: CBT; Behavioral: Group Activities

Control

NO INTERVENTION

Control group

Group activities

EXPERIMENTAL

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.

Behavioral: Group Activities

Interventions

CBT BEHAVIORAL

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

CBT home visits; CBT home visits and group activities

Group Activities BEHAVIORAL

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

CBT home visits and group activities; Group activities

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 55 years of age
• Women

You may not qualify if:

• Those with hearing, speech or mental impairment

Sponsors & Collaborators

• National Bureau of Economic Research, Inc.: lead
• Abdul Latif Jameel Poverty Action Lab: collaborator

Study Sites (2)

JPAL SA at IFMR

Chennai, Tamil Nadu, 600018, India

RECRUITING

JPAL SA at IFMR

Chennai, Tamil Nadu, India

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Esther Duflo, PhD

CONTACT

(617) 324-4867; eduflo@mit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 12, 2023
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

IN (2)