The Health and Social Consequences of Depression Among the Elderly
- Conditions
- DepressionFunctional Impairment
- Interventions
- Behavioral: CBTBehavioral: Group Activities
- Registration Number
- NCT05856552
- Lead Sponsor
- National Bureau of Economic Research, Inc.
- Brief 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 over a 12-week period. 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 12-week intervention and 6 months after the intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 5370
- At least 55 years of age
- Women
- Those with hearing, speech or mental impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description CBT home visits and group activities 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. CBT home visits CBT Community resource persons will visit the elderly women once per week to deliver cognitive behavioral therapy for six weeks, followed by monthly boosters. Group activities 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. CBT home visits and group activities CBT 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.
- Primary Outcome Measures
Name Time Method Mental health 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 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.
- Secondary Outcome Measures
Name Time Method Loneliness/Social Connectedness Assessed at 6 months after the intervention 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.
Cognitive function Assessed at 6 months after the intervention 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.
Sleep Assessed at 6 months after the intervention 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.
Perceived Health Status Assessed at 6 months after the intervention 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.
Physical Mobility Assessed at 6 months after the intervention 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.
Health Management Behavior Assessed at 6 months after the intervention The measure of health management behavior will be comprised of one measure. The measure is a self-reported question about use of common check-up services in the last 12 months. 1 indicates that the subject did the activity and 0 otherwise.
Demand for Intervention Activities Assessed at 6 months after the intervention The demand for interventions measure is a standardized index combining three components. First, 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. Second, the sum of how much subjects think they will enjoy five activities from the group activities curriculum: yoga, breathing exercises, laughter therapy, conversations, and games (1=Not at all to 4=Very much). Third, how much subjects think they will enjoy discussing their personal life with the local CRP (1=Not at all to 4=Very much). The index is constructed so higher values indicate greater demand for either intervention.
Agency Assessed at 6 months after the intervention 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.
Trial Locations
- Locations (1)
JPAL SA at IFMR
🇮🇳Chennai, Tamil Nadu, India