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Recruiting NCT05856552

The Health and Social Consequences of Depression Among the Elderly

No phase Interventional Depression Functional Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBT, Group Activities.
Who it may be relevant to
Registry conditions: Depression, Functional Impairment. Basic parameters: from 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Health and Social Consequences of Depression Among the Elderly: Evidence From India

Overview

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.

Interventions

  • Behavioral CBT
    Cognitive behavioral therapy delivered by community resource persons via home visits.
  • Behavioral Group Activities
    Weekly hour-long group activities delivered by community resource persons in community spaces.

Primary outcome measures

  • Depression Score [Time frame: Assessed at 0 months after the intervention]
  • Depression Score [Time frame: Assessed at 6 months after the intervention]
  • Difficulty in performing daily activities/Functional impairment score [Time frame: Assessed at 0 months after the intervention]
  • Difficulty in performing daily activities/Functional impairment score [Time frame: Assessed at 6 months after the intervention]
Secondary outcome measures (11)
  • Loneliness/Social Connectedness [Time frame: Assessed at 0 months after the intervention]
  • Loneliness/Social Connectedness [Time frame: Assessed at 6 months after the intervention]
  • Cognitive function [Time frame: Assessed at 0 months after the intervention]
  • Cognitive function [Time frame: Assessed at 6 months after the intervention]
  • Objective Measures of Sleep [Time frame: Assessed at 0 months after the intervention]
  • Perceived Health Status [Time frame: Assessed at 0 months after the intervention]
  • Perceived Health Status [Time frame: Assessed at 6 months after the intervention]
  • Physical Mobility [Time frame: Assessed at 0 months after the intervention]
  • Physical Mobility [Time frame: Assessed at 6 months after the intervention]
  • Agency [Time frame: Assessed at 0 months after the intervention]
  • Agency [Time frame: Assessed at 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Prevention

Study locations

India · 2 centers
  • JPAL SA at IFMR — Chennai
  • JPAL SA at IFMR — Chennai

Identifiers

NCT: NCT05856552 · 23003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗