Clinical trial NCT05856552: The Health and Social Consequences of Depression Among the Elderly
Official title: The Health and Social Consequences of Depression Among the Elderly: Evidence from India
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Functional Impairment
Keywords: Elderly
India
CBT
Group activities
Depression
Lead sponsor: National Bureau of Economic Research, Inc.
Sponsor class: OTHER
Collaborators: name: Abdul Latif Jameel Poverty Action Lab
First posted: 2023-05-12
Enrollment: 5370
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* At least 55 years of age
* Women

Exclusion Criteria:

* Those with hearing, speech or mental impairment

Primary outcomes:
measure: Mental health
timeFrame: Assessed at 0 months after the intervention
measure: Mental health
timeFrame: Assessed at 6 months after the intervention
measure: Difficulty in performing daily activities/Functional impairment score
timeFrame: Assessed at 0 months after the intervention
measure: Difficulty in performing daily activities/Functional impairment score
timeFrame: Assessed at 6 months after the intervention
Secondary outcomes:
measure: Loneliness/Social Connectedness
timeFrame: Assessed at 0 months after the intervention
measure: Loneliness/Social Connectedness
timeFrame: Assessed at 6 months after the intervention
measure: Cognitive function
timeFrame: Assessed at 0 months after the intervention
measure: Cognitive function
timeFrame: Assessed at 6 months after the intervention
measure: Sleep
timeFrame: Assessed at 0 months after the intervention
measure: Sleep
timeFrame: Assessed at 6 months after the intervention
measure: Perceived Health Status
timeFrame: Assessed at 0 months after the intervention
measure: Perceived Health Status
timeFrame: Assessed at 6 months after the intervention
measure: Physical Mobility
timeFrame: Assessed at 0 months after the intervention
measure: Physical Mobility
timeFrame: Assessed at 6 months after the intervention
measure: Health Management Behavior
timeFrame: Assessed at 0 months after the intervention
measure: Health Management Behavior
timeFrame: Assessed at 6 months after the intervention
measure: Demand for Intervention Activities
timeFrame: Assessed at 0 months after the intervention
measure: Demand for Intervention Activities
timeFrame: Assessed at 6 months after the intervention
measure: Agency
timeFrame: Assessed at 0 months after the intervention
measure: Agency
timeFrame: Assessed at 6 months after the intervention
Other outcomes:
Locations:
city: Chennai
country: India
facility: JPAL SA at IFMR
state: Tamil Nadu
city: Chennai
country: India
facility: JPAL SA at IFMR
state: Tamil Nadu
Study officials:
References: