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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
5,370
Cognitive behavioral therapy delivered by community resource persons via home visits.
Weekly hour-long group activities delivered by community resource persons in community spaces.
JPAL SA at IFMR
Chennai, Tamil Nadu, India
RECRUITINGJPAL SA at IFMR
Chennai, Tamil Nadu, India
ACTIVE_NOT_RECRUITINGDepression 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at 6 months after the intervention
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at 6 months after the intervention