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DepressionNCT05856552

The Health and Social Consequences of Depression Among the Elderly

A study testing CBT and Group Activities in people with Depression and Functional Impairment, run by National Bureau of Economic Research, Inc. at 2 sites in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Depression, Functional Impairment
What is being tested?
CBT and Group Activities
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,370 participants
Where
2 sitesIndia
Study dates
20 Nov 2024to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • At least 55 years of age
  • Women

Who cannot join

  • Those with hearing, speech or mental impairment

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Esther Duflo, PhD contact

(617) 324-4867

eduflo@mit.edu

India2 sites, 1 recruiting
  • JPAL SA at IFMR

    Chennai, Tamil Nadu, 600018

    Shrddha Rajesh (Senior Research Associate at J-PAL), +91 96770 25388, srajesh@povertyactionlab.org

    Recruiting
  • JPAL SA at IFMR

    Chennai, Tamil Nadu

    Active, not recruiting

Other trials in India

About this study

Official title: The Health and Social Consequences of Depression Among the Elderly: Evidence From India

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.

Being tested
CBT, Group Activities
Keywords
Elderly, India, CBT, Group activities, Depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBTBehavioural

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

  • Group ActivitiesBehavioural

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

Study groups in NCT05856552
Study groupRoleWhat they receive
CBT home visitsExperimentalCommunity 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.
Receives: Behavioral: CBT
CBT home visits and group activitiesExperimentalCommunity 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.
Receives: Behavioral: CBT; Behavioral: Group Activities
ControlNo interventionControl group
Group activitiesExperimentalThe 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.
Receives: Behavioral: Group Activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed at 0 months after the intervention

  2. 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.

    Measured: Assessed at 6 months after the intervention

  3. 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.

    Measured: Assessed at 0 months after the intervention

  4. 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.

    Measured: Assessed at 6 months after the intervention

Secondary outcomes (11)
  1. Loneliness/Social Connectedness

    This measure is a standardized index combining five components. First, a 3-item short-form UCLA Loneliness Scale (ULS-3): feeling of lacking companionship, being left out, and isolation (1=Hardly ever, 2=Some of the time, 3=Often; summed). Second, a direct report of loneliness: whether the subject felt lonely last week (1=Yes, 0=No). Third, the Perceived Social Support scale, summing responses to 8 items from Family and Friends subscales (1=Very strongly disagree to 7=Very strongly agree) about emotional support, decision-making help, and sharing joys/sorrows. Fourth, a 2-item Emotional Connection subscale from the Brief Sense of Community Scale, assessing connection to the neighborhood and bond with neighbors (1=Strongly disagree to 7=Strongly agree). Fifth, a single question on the number of close friendships. Measures 1 and 2 are inverted, and all components combined to create an index where higher values indicate greater social connectedness.

    Measured: Assessed at 0 months after the intervention

  2. Loneliness/Social Connectedness

    The social connectedness measure is a standardized index combining five components. First, a 3-item short-form UCLA Loneliness Scale (ULS-3): feeling of lacking companionship, being left out, and isolation (1=Hardly ever, 2=Some of the time, 3=Often; summed). Second, a direct report of loneliness: whether the subject felt lonely last week (1=Yes, 0=No). Third, the Perceived Social Support scale, summing responses to 8 items from Family and Friends subscales (1=Very strongly disagree to 7=Very strongly agree) about emotional support, decision-making help, and sharing joys/sorrows. Fourth, a 2-item Emotional Connection subscale from the Brief Sense of Community Scale, assessing connection to the neighborhood and bond with neighbors (1=Strongly disagree to 7=Strongly agree). Fifth, a single question on the number of close friendships. Measures 1 and 2 are inverted, and all components combined to create an index where higher values indicate greater social connectedness.

    Measured: Assessed at 6 months after the intervention

  3. Cognitive function

    Participants will be administered the Mini Mental State Exam. Elders are asked 11 questions and tasks that evaluate various cognitive domains, such as orientation, memory, attention, language, and visuospatial skills. If the question or task is completed correctly, the item receives a score of 1, and 0 otherwise. Scores are summed such that a higher score indicates better cognitive function. The maximum possible score is 30 points.

    Measured: Assessed at 0 months after the intervention

  4. Cognitive function

    Participants will be administered the Mini Mental State Exam. Elders are asked 11 questions and tasks that evaluate various cognitive domains, such as orientation, memory, attention, language, and visuospatial skills. If the question or task is completed correctly, the item receives a score of 1, and 0 otherwise. Scores are summed such that a higher score indicates better cognitive function. The maximum possible score is 30 points.

    Measured: Assessed at 6 months after the intervention

  5. Objective Measures of Sleep

    This is a standardized index combining two components comprised of Actigraph device-measured data (subset ~N=1,000): total sleep time and sleep efficiency (asleep time/bedtime). Actigraph data is collected 1 month pre- to 2 months post-intervention. Both measures are combined to form an index, with higher scores indicating better sleep.

    Measured: Assessed at 0 months after the intervention

  6. Perceived Health Status

    The measure of perceived health status will be a standardized index constructed with two measures. The first measure is self-reported summary of overall health on a scale of 1=Very poor to 5=Very good. The second measures is self-assessed physical pain in the last week on a scale of 0= "no pain" and 10 ="worst pain possible". The second measure of the index will be inverted such that higher values correspond to better perceived health and lower pain.

    Measured: Assessed at 0 months after the intervention

  7. Perceived Health Status

    The measure of perceived health status will be a standardized index constructed with two measures. The first measure is self-reported summary of overall health on a scale of 1=Very poor to 5=Very good. The second measures is self-assessed physical pain in the last week on a scale of 0= "no pain" and 10 ="worst pain possible". The second measure of the index will be inverted such that higher values correspond to better perceived health and lower pain.

    Measured: Assessed at 6 months after the intervention

  8. Physical Mobility

    The mobility measure is a standardized index combining three components. First, a self-reported question on whether the elder left home the previous day (1=Yes, 0=No). Second, frequency of engaging in two activities: walking at a moderate pace or floor/stretching/gentle yoga exercises (1=Hardly ever/never to 5=Everyday). Third, a per-day average step count based on Actigraph device data for a subset (~N=1,000). Actigraph measurements are collected from 1 month before to 2 months after the intervention period. When Actigraph data is available, all three measures are combined into an index where higher values indicate greater mobility. If Actigraph data is unavailable, the index is constructed using the first two components.

    Measured: Assessed at 0 months after the intervention

  9. Physical Mobility

    The measure of mobility will be a standardized index constructed with two measures. The first measure is self-reported mobility question about whether the elder left home the day before, where the responses are either 1 if they did or 0 if they did not. The second measure is a measure of how frequently elders engage in two activities: walking at a moderate pace or floor/stretching/gentle yoga exercises. Responses vary from 1 "Hardly ever/never" to "5 = Everyday". The index is constructed such that an increase in the index corresponds to more mobility.

    Measured: Assessed at 6 months after the intervention

  10. Agency

    The measure of agency will be measured with a standardized index comprised of two measures. The first measure is a question of the subject's locus of control from the World Values Survey where the subject is asked the extent to which they feel that they have free choice and control over their lives on a scale of 1=No choice at all to 10=A great deal of choice. The second measure is a 2-question subset of the Generalized Self-Efficacy scale that asks about whether the subject feels they can solve most problems with effort and whether they can find several solutions on a scale of 0=No completely to 3=Yes completely. The index is constructed such that an increase in the index corresponds to an increase in agency, capturing higher locus of control and more self-efficacy.

    Measured: Assessed at 0 months after the intervention

  11. Agency

    The measure of agency will be measured with a standardized index comprised of two measures. The first measure is a question of the subject's locus of control from the World Values Survey where the subject is asked the extent to which they feel that they have free choice and control over their lives on a scale of 1=No choice at all to 10=A great deal of choice. The second measure is a 2-question subset of the Generalized Self-Efficacy scale that asks about whether the subject feels they can solve most problems with effort and whether they can find several solutions on a scale of 0=No completely to 3=Yes completely. The index is constructed such that an increase in the index corresponds to an increase in agency, capturing higher locus of control and more self-efficacy.

    Measured: Assessed at 6 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start20 Nov 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05856552
Sponsor's protocol ID
23003
Status last verified
Nov 2025
First submitted
24 Apr 2023
Last updated
26 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CBT and Group Activities in people with Depression and Functional Impairment, run by National Bureau of Economic Research, Inc. at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esther Duflo, PhD ((617) 324-4867, eduflo@mit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Score (time frame: Assessed at 0 months after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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