The Health and Social Consequences of Depression Among the Elderly

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05856552
• Other study ID #: 23003
• Secondary ID: P01AG005842
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2028

Study information

• Verified date: November 2023
• Source: National Bureau of Economic Research, Inc.
• Contact: Esther Duflo, PhD
• Phone: (617) 324-4867
• Email: eduflo[@]mit.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• At least 58 years of age
• Women Exclusion Criteria: -

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
India	JPAL SA at IFMR	Chennai	Tamil Nadu

Sponsors (3)

Lead Sponsor	Collaborator
National Bureau of Economic Research, Inc.	Abdul Latif Jameel Poverty Action Lab, National Institute on Aging (NIA)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental health	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
Primary	Mental health	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
Primary	Mental health	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
Primary	Difficulty in performing daily activities/Functional impairment score	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
Primary	Difficulty in performing daily activities/Functional impairment score	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
Primary	Difficulty in performing daily activities/Functional impairment score	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	Loneliness	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
Secondary	Loneliness	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
Secondary	Loneliness	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
Secondary	Cognitive function	Participants will be administered the mini mental state exam, scored on a 0-11 scale.	Assessed at 3 months after the intervention
Secondary	Cognitive function	Participants will be administered the mini mental state exam, scored on a 0-11 scale.	Assessed at 1 year after the intervention
Secondary	Cognitive function	Participants will be administered the mini mental state exam, scored on a 0-11 scale.	Assessed at 3 years after the intervention
Secondary	Sleep	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
Secondary	Sleep	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
Secondary	Sleep	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
Secondary	Self-assessed pain	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
Secondary	Self-assessed pain	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
Secondary	Self-assessed pain	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
Secondary	Community and social integration	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
Secondary	Community and social integration	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
Secondary	Community and social integration	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
Secondary	Health outcomes	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
Secondary	Health outcomes	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
Secondary	Health behavior	Participants will be asked if they avail free screening of Diseases at Government Hospitals (0/1).	Assessed at 3 months after the intervention
Secondary	Health behavior	Participants will be asked if they avail free screening of Diseases at Government Hospitals (0/1).	Assessed at 1 year after the intervention
Secondary	Health behavior	Participants will be asked if they avail free screening of Diseases at Government Hospitals (0/1).	Assessed at 3 years after the intervention
Secondary	Health utilization	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
Secondary	Health utilization	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
Secondary	Health utilization	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
Secondary	CBT utilization	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
Secondary	CBT utilization	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
Secondary	CBT utilization	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