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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
India2 sites, 1 recruiting
- Recruiting
JPAL SA at IFMR
Chennai, Tamil Nadu, 600018
Shrddha Rajesh (Senior Research Associate at J-PAL), +91 96770 25388, srajesh@povertyactionlab.org
- Active, not recruiting
JPAL SA at IFMR
Chennai, Tamil Nadu
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.
- Conditions
- Depression, Functional Impairment
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Group Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted12 May 2023
- Study start20 Nov 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Bureau of Economic Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health and Social Consequences of Depression Among the Elderly: Evidence From India
- ClinicalTrials.gov ID
- NCT05856552
- Acronym / sponsor ID
- 23003
- Conditions
- Depression, Functional Impairment
- Keywords
- Elderly, India, CBT, Group activities, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,370 participants (estimated)
- Lead sponsor
- National Bureau of Economic Research, Inc.University, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT home visits | Experimental | Behavioral: CBTCommunity 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. |
| CBT home visits and group activities | Experimental | Behavioral: CBT, Behavioral: Group ActivitiesCommunity 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. |
| Control | No intervention | –Control group |
| Group activities | Experimental | Behavioral: Group ActivitiesThe 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 55 years of age
- Women
Key exclusion criteria (1 listed)
- Those with hearing, speech or mental impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTCognitive behavioral therapy delivered by community resource persons via home visits. | Behavioural | CBT home visits, CBT home visits and group activities |
| Group ActivitiesWeekly hour-long group activities delivered by community resource persons in community spaces. | Behavioural | CBT home visits and group activities, Group activities |
Primary outcome
Depression Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
11 secondary outcomes
Loneliness/Social Connectedness
Time frame: Assessed at 0 months after the intervention
Loneliness/Social Connectedness
Time frame: Assessed at 6 months after the intervention
Cognitive function
Time frame: Assessed at 0 months after the intervention
Cognitive function
Time frame: Assessed at 6 months after the intervention
Objective Measures of Sleep
Time frame: Assessed at 0 months after the intervention
Perceived Health Status
Time frame: Assessed at 0 months after the intervention
Perceived Health Status
Time frame: Assessed at 6 months after the intervention
Physical Mobility
Time frame: Assessed at 0 months after the intervention
Physical Mobility
Time frame: Assessed at 6 months after the intervention
Agency
Time frame: Assessed at 0 months after the intervention
Agency
Time frame: Assessed at 6 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.