- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856552
The Health and Social Consequences of Depression Among the Elderly
November 17, 2023 updated by: National Bureau of Economic Research, Inc.
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 three treatment arms: one for CBT during home visits, one for CBT and facilitated group activities, and a control group receiving neither the CBT nor facilitated group activities.
Randomization will be at the hamlet/block level.
A control group will receive no intervention.
Investigators will track outcomes of the elderly at 3 months, 1 year, and 3 years after the intervention.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
3000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Esther Duflo, PhD
- Phone Number: (617) 324-4867
- Email: eduflo@mit.edu
Study Locations
-
-
Tamil Nadu
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Chennai, Tamil Nadu, India
- JPAL SA at IFMR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- At least 58 years of age
- Women
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Control group
|
|
Experimental: CBT home visits
Community resource persons will visit the elderly women once per week to deliver cognitive behavioral therapy for six weeks, followed by monthly boosters.
|
Cognitive behavioral therapy delivered by community resource persons via home visits.
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Experimental: 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 monthly boosters.
The elderly women and their families will also be invited to join weekly hour-long group activities for 6 weeks.
Group activities will be administered by community resource persons in community spaces.
|
Cognitive behavioral therapy delivered by community resource persons via home visits.
Weekly hour-long group activities delivered by community resource persons in community spaces.
|
Experimental: Group activities
The elderly women and their families will be invited to join weekly hour-long group activities for 6 weeks.
Group activities will be administered by community resource persons in community spaces.
|
Weekly hour-long group activities delivered by community resource persons in community spaces.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental health
Time Frame: Assessed at 3 months after the intervention
|
The geriatric depression scale short form is used.
Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, 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 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).
|
Assessed at 3 months after the intervention
|
Mental health
Time Frame: Assessed at 1 year after the intervention
|
The geriatric depression scale short form is used.
Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, 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 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).
|
Assessed at 1 year after the intervention
|
Mental health
Time Frame: Assessed at 3 years after the intervention
|
The geriatric depression scale short form is used.
Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, 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 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).
|
Assessed at 3 years after the intervention
|
Difficulty in performing daily activities/Functional impairment score
Time Frame: Assessed at 3 months after the intervention
|
Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, 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 3 months after the intervention
|
Difficulty in performing daily activities/Functional impairment score
Time Frame: Assessed at 1 year after the intervention
|
Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, 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 1 year after the intervention
|
Difficulty in performing daily activities/Functional impairment score
Time Frame: Assessed at 3 years after the intervention
|
Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, 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 3 years after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Loneliness
Time Frame: Assessed at 3 months after the intervention
|
Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4).
This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it.
Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way").
Responses are summed over the four questions.
|
Assessed at 3 months after the intervention
|
Loneliness
Time Frame: Assessed at 1 year after the intervention
|
Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4).
This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it.
Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way").
Responses are summed over the four questions.
|
Assessed at 1 year after the intervention
|
Loneliness
Time Frame: Assessed at 3 years after the intervention
|
Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4).
This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it.
Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way").
Responses are summed over the four questions.
|
Assessed at 3 years after the intervention
|
Cognitive function
Time Frame: Assessed at 3 months after the intervention
|
Participants will be administered the mini mental state exam, scored on a 0-11 scale.
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Assessed at 3 months after the intervention
|
Cognitive function
Time Frame: Assessed at 1 year after the intervention
|
Participants will be administered the mini mental state exam, scored on a 0-11 scale.
|
Assessed at 1 year after the intervention
|
Cognitive function
Time Frame: Assessed at 3 years after the intervention
|
Participants will be administered the mini mental state exam, scored on a 0-11 scale.
|
Assessed at 3 years after the intervention
|
Sleep
Time Frame: Assessed at 3 months after the intervention
|
Using self-reported information about sleep (including average hours slept per night over the past week, if sleep is interrupted as an indicator variable, and scale of sleep quality on a scale from 1 indicating "Very Good" to 4 indicating "Very Bad").
The indicator for sleep interruptions and the scale for sleep quality will be flipped.
The three questions will then be combined to create an index where an increase in the index indicates better sleep.
|
Assessed at 3 months after the intervention
|
Sleep
Time Frame: Assessed at 1 year after the intervention
|
Using self-reported information about sleep (including average hours slept per night over the past week, if sleep is interrupted as an indicator variable, and scale of sleep quality on a scale from 1 indicating "Very Good" to 4 indicating "Very Bad").
The indicator for sleep interruptions and the scale for sleep quality will be flipped.
The three questions will then be combined to create an index where an increase in the index indicates better sleep.
|
Assessed at 1 year after the intervention
|
Sleep
Time Frame: Assessed at 3 years after the intervention
|
Using self-reported information about sleep (including average hours slept per night over the past week, if sleep is interrupted as an indicator variable, and scale of sleep quality on a scale from 1 indicating "Very Good" to 4 indicating "Very Bad").
The indicator for sleep interruptions and the scale for sleep quality will be flipped.
The three questions will then be combined to create an index where an increase in the index indicates better sleep.
|
Assessed at 3 years after the intervention
|
Self-assessed pain
Time Frame: Assessed at 3 months after the intervention
|
Using self-assessed pain on a scale where 0 is "no pain" and 10 is "worst pain possible".
|
Assessed at 3 months after the intervention
|
Self-assessed pain
Time Frame: Assessed at 1 year after the intervention
|
Using self-assessed pain on a scale where 0 is "no pain" and 10 is "worst pain possible".
|
Assessed at 1 year after the intervention
|
Self-assessed pain
Time Frame: Assessed at 3 years after the intervention
|
Using self-assessed pain on a scale where 0 is "no pain" and 10 is "worst pain possible".
|
Assessed at 3 years after the intervention
|
Community and social integration
Time Frame: Assessed at 3 months after the intervention
|
Elders asked whether they were visited or had visited someone in the last month.
Elders were asked how frequently they: attend a public meeting, meet personally with a community leader, work with other people in their neighborhood to fix or improve something, attend cultural performances or shows, talk on the phone with relatives or friends outside the household (scale of "Never", "Once or Twice per Year", "Once or Twice per Month", "Once or Twice per Week", "Daily").
Elders also asked if they are treated with respect within their household (responses include "Yes, all the time", "Mostly yes", and "Never").
Three subindices will be created for visits, participation in community activities, and feeling respected.
The three subindices will then be combined into who index where an increase in the index indicates greater community and social integration.
|
Assessed at 3 months after the intervention
|
Community and social integration
Time Frame: Assessed at 1 year after the intervention
|
Elders asked whether they were visited or had visited someone in the last month.
Elders were asked how frequently they: attend a public meeting, meet personally with a community leader, work with other people in their neighborhood to fix or improve something, attend cultural performances or shows, talk on the phone with relatives or friends outside the household (scale of "Never", "Once or Twice per Year", "Once or Twice per Month", "Once or Twice per Week", "Daily").
Elders also asked if they are treated with respect within their household (responses include "Yes, all the time", "Mostly yes", and "Never").
Three subindices will be created for visits, participation in community activities, and feeling respected.
The three subindices will then be combined into who index where an increase in the index indicates greater community and social integration.
|
Assessed at 1 year after the intervention
|
Community and social integration
Time Frame: Assessed at 3 years after the intervention
|
Elders asked whether they were visited or had visited someone in the last month.
Elders were asked how frequently they: attend a public meeting, meet personally with a community leader, work with other people in their neighborhood to fix or improve something, attend cultural performances or shows, talk on the phone with relatives or friends outside the household (scale of "Never", "Once or Twice per Year", "Once or Twice per Month", "Once or Twice per Week", "Daily").
Elders also asked if they are treated with respect within their household (responses include "Yes, all the time", "Mostly yes", and "Never").
Three subindices will be created for visits, participation in community activities, and feeling respected.
The three subindices will then be combined into who index where an increase in the index indicates greater community and social integration.
|
Assessed at 3 years after the intervention
|
Health outcomes
Time Frame: Assessed at 1 year after the intervention
|
The investigators will construct indicators for abnormal readings for biomarkers (including blood pressure, blood sugar, and anemia), and abnormal readings for elder's ability to perform basic physical tasks (a time up and go test and an endurance test that counts the number of unassisted stands an elder can complete).
Health measurements will be combined into an index where an increase in the index indicates worse health.
|
Assessed at 1 year after the intervention
|
Health outcomes
Time Frame: Assessed at 3 years after the intervention
|
The investigators will construct indicators for abnormal readings for biomarkers (including blood pressure, blood sugar, and anemia), and abnormal readings for elder's ability to perform basic physical tasks (a time up and go test and an endurance test that counts the number of unassisted stands an elder can complete).
Health measurements will be combined into an index where an increase in the index indicates worse health.
|
Assessed at 3 years after the intervention
|
Health behavior
Time Frame: Assessed at 3 months after the intervention
|
Participants will be asked if they avail free screening of Diseases at Government Hospitals (0/1).
|
Assessed at 3 months after the intervention
|
Health behavior
Time Frame: Assessed at 1 year after the intervention
|
Participants will be asked if they avail free screening of Diseases at Government Hospitals (0/1).
|
Assessed at 1 year after the intervention
|
Health behavior
Time Frame: Assessed at 3 years after the intervention
|
Participants will be asked if they avail free screening of Diseases at Government Hospitals (0/1).
|
Assessed at 3 years after the intervention
|
Health utilization
Time Frame: Assessed at 3 months after the intervention
|
Participants will be offered to complete a medical exam on the spot.
Outcome will be if the elder chooses to participate in the medical test (0/1).
|
Assessed at 3 months after the intervention
|
Health utilization
Time Frame: Assessed at 1 year after the intervention
|
Participants will be offered to complete a medical exam on the spot.
Outcome will be if the elder chooses to participate in the medical test (0/1).
|
Assessed at 1 year after the intervention
|
Health utilization
Time Frame: Assessed at 3 years after the intervention
|
Participants will be offered to complete a medical exam on the spot.
Outcome will be if the elder chooses to participate in the medical test (0/1).
|
Assessed at 3 years after the intervention
|
CBT utilization
Time Frame: Assessed at 3 months after the intervention
|
Participants will be given a scenario about an elder facing a problem.
Elders will be asked what they would suggest the elder do, with options that include activities discussed in the CBT sessions.
Outcome will be if elder selects a method discussed in CBT curriculum.
|
Assessed at 3 months after the intervention
|
CBT utilization
Time Frame: Assessed at 1 year after the intervention
|
Participants will be given a scenario about an elder facing a problem.
Elders will be asked what they would suggest the elder do, with options that include activities discussed in the CBT sessions.
Outcome will be if elder selects a method discussed in CBT curriculum.
|
Assessed at 1 year after the intervention
|
CBT utilization
Time Frame: Assessed at 3 years after the intervention
|
Participants will be given a scenario about an elder facing a problem.
Elders will be asked what they would suggest the elder do, with options that include activities discussed in the CBT sessions.
Outcome will be if elder selects a method discussed in CBT curriculum.
|
Assessed at 3 years after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
April 24, 2023
First Submitted That Met QC Criteria
May 3, 2023
First Posted (Actual)
May 12, 2023
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23003
- P01AG005842 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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