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Recruiting Not applicable

The Health and Social Consequences of Depression Among the Elderly

NCT05856552 · tracked via the Priya Life Science India tracker
Sponsor
National Bureau of Economic Research, Inc
Phase
Not applicable
Started
2024-11-20
Last updated
2025-11-26

Condition(s) studied

DepressionFunctional Impairment

Investigational drug(s) / intervention(s)

CBTGroup Activities

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

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

Study 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.

Eligibility

Sex
FEMALE
Min age
55 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * At least 55 years of age * Women Exclusion Criteria: * Those with hearing, speech or mental impairment

Primary outcome measure(s)

  • Depression Score — Assessed at 0 months after the intervention
    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.
  • Depression Score — Assessed at 6 months after the intervention
    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.
  • Difficulty in performing daily activities/Functional impairment score — Assessed at 0 months after the intervention
    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.
  • Difficulty in performing daily activities/Functional impairment score — Assessed at 6 months after the intervention
    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.

Trial sites (2)

FacilityCityRegionStatus
JPAL SA at IFMR Chennai Tamil Nadu Recruiting
JPAL SA at IFMR Chennai Tamil Nadu Active Not Recruiting

More National Bureau of Economic Research, Inc. trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05856552 on ClinicalTrials.gov ↗ ← All trials in India