The Health and Social Consequences of Depression Among the Elderly

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55+
SponsorNational Bureau of Economic Research, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least 55 years of age

Women

Disqualifiers

Those with hearing, speech or mental impairment

Trial design

Design model

Factorial

Treatments tested in this trial

  • CBT

    Behavioral

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

  • Group Activities

    Behavioral

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

Treatment groups

5,370 Participants
are divided into 4 treatment groups
Group A: CBT home visitsExperimental treatment 1 intervention
Group B: CBT home visits and group activitiesExperimental treatment 2 interventions
Group C: ControlNo intervention 0 interventions
Group D: Group activitiesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Assessed at 6 months after the intervention

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Assessed at 6 months after the intervention

Other outcomes

1

Self-reported Measures of Sleep

This is a standardized index combining three components. First, self-reported sleep hours based on sleep/wake times. Second, a 7-item Sleep and Insomnia Severity Index assessing the past two weeks: difficulty falling/staying asleep, waking too early (1=None to 5=Very severe), sleep satisfaction (1=Very satisfied to 5=Very dissatisfied), interference with daily function (1=Not at all to 5=Very much), impact on quality of life (1=Not noticeable to 5=Very noticeable), and worry about sleep (1=Not at all to 5=Very much). Third, a Pittsburgh Sleep Quality Index item on overall sleep quality in the past month (1=Very good to 4=Very bad). Measures 2 and 3 are inverted, and all measures are combined to form an index, with higher scores indicating better sleep.

Time frame
Assessed at 0 months after the intervention
2

Self-reported Measures of Sleep

This is a standardized index combining three components. First, self-reported sleep hours based on sleep/wake times. Second, a 7-item Sleep and Insomnia Severity Index assessing the past two weeks: difficulty falling/staying asleep, waking too early (1=None to 5=Very severe), sleep satisfaction (1=Very satisfied to 5=Very dissatisfied), interference with daily function (1=Not at all to 5=Very much), impact on quality of life (1=Not noticeable to 5=Very noticeable), and worry about sleep (1=Not at all to 5=Very much). Third, a Pittsburgh Sleep Quality Index item on overall sleep quality in the past month (1=Very good to 4=Very bad). Measures 2 and 3 are inverted, and all measures are combined to form an index, with higher scores indicating better sleep.

Time frame
Assessed at 6 months after the intervention
3

Demand for Intervention Activities

The demand for interventions measure is an indicator equal to 1 if the subject prefers either intervention (CBT or Group Activities) over a cash transfer in a hypothetical choice, and 0 if they prefer the cash transfer. This comes from a question asking subjects to rank their preference between a Group Activities program, CBT program, or a one-time 1,000 Rs cash transfer.

Time frame
Assessed at 0 months after the intervention
4

Demand for Intervention Activities

The demand for interventions measure is an indicator equal to 1 if the subject prefers either intervention (CBT or Group Activities) over a cash transfer in a hypothetical choice, and 0 if they prefer the cash transfer. This comes from a question asking subjects to rank their preference between a Group Activities program, CBT program, or a one-time 1,000 Rs cash transfer.

Time frame
Assessed at 6 months after the intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Bureau of Economic Research, Inc.

Lead sponsor

Abdul Latif Jameel Poverty Action Lab

Collaborator