The Health and Social Consequences of Depression Among the Elderly: Evidence From India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,370
- 试验地点
- 2
- 主要终点
- Difficulty in performing daily activities/Functional impairment score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •At least 55 years of age
排除标准
- •Those with hearing, speech or mental impairment
结局指标
主要结局
Difficulty in performing daily activities/Functional impairment score
时间窗: 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.
Depression Score
时间窗: 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
时间窗: 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.
次要结局
- Cognitive function(Assessed at 6 months after the intervention)
- Perceived Health Status(Assessed at 6 months after the intervention)
- Physical Mobility(Assessed at 6 months after the intervention)
- Loneliness/Social Connectedness(Assessed at 6 months after the intervention)
- Agency(Assessed at 6 months after the intervention)
- Loneliness/Social Connectedness(Assessed at 6 months after the intervention)
- Cognitive function(Assessed at 6 months after the intervention)
- Objective Measures of Sleep(Assessed at 0 months after the intervention)
- Perceived Health Status(Assessed at 6 months after the intervention)
- Physical Mobility(Assessed at 6 months after the intervention)
- Agency(Assessed at 6 months after the intervention)