Village-based Intervention for Late-life Depression

NCT ID: NCT04013165

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-03-31

Brief Summary

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Investigators aimed to examine the feasibility and effectiveness of a village-based multilevel intervention for late-life depression. Two small rural villages in rural South Korea were selected as the intervention group and active control. All older adults living in the two villages were included in the intervention program or received standard CMHS care, and the effectiveness of the program was examined using representative samples from both groups.

Detailed Description

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OBJECTIVES: To examine the feasibility and effectiveness of a village-based multilevel intervention for late-life depression, focusing on strengthening the autonomy of village-dwellers with help from the community mental health service (CMHS).

DESIGN: A community-based randomized trial with participants (all village-dwellers) assigned to two parallel programs: intervention program or the CMHS's usual care.

SETTING: Two small villages in a rural area of South Korea

PARTICIPANTS: All older adults (aged ≥65 years) living in the two villages were included in the intervention or the CMHS's usual care, and the effectiveness of the program was examined using representative samples who were age- and sex-stratified randomly selected from both groups.

INTERVENTION: A 12-week intervention was comprised of individual-based risk-stratified case management and group-based activities.

MEASUREMENTS: The Korean version of Geriatric Depression Scale-Short form (SGDS-K) was used as the primary outcome while depressive episodes, suicidal ideation/plans/attempts, social network, functional status, and global cognitive function were measured as secondary outcomes.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A community-based randomized controlled pilot study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Active control

Usual care of the Community Mental Health Service

Group Type ACTIVE_COMPARATOR

Active control

Intervention Type BEHAVIORAL

Control group received usual care of the Community Mental Health Service, consisted of case management for high-risk older adults and referral to psychiatric services.

Village-based intervention

Individual-based case management + group-based program

Group Type EXPERIMENTAL

Village-based intervention

Intervention Type BEHAVIORAL

1. Individual-based case management was conducted both by healthy community dwellers (local committee) and Community Mental Health Service (CMHS) team based on risk-stratification for depression in older adults. Local committee-guided care was performed after matching a healthy dweller with 4-5 older neighbors included in risk groups. They visited the matched older individuals as often as possible at least once a week using a mood sticker. The CMHS team also conducted a separate case management for older adults with risk-stratified protocols; the higher the risk of suicide, the more intensive was the management, which could include frequent face-to-face visits. High-risk individuals were also referred to the psychiatric service, if deemed necessary.
2. Group-based program was comprised of weekly eight sessions, which were mainly consisted of programs enhancing interpersonal network and group cohesion, and were open to all community-dwelling older adults.

Interventions

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Active control

Control group received usual care of the Community Mental Health Service, consisted of case management for high-risk older adults and referral to psychiatric services.

Intervention Type BEHAVIORAL

Village-based intervention

1. Individual-based case management was conducted both by healthy community dwellers (local committee) and Community Mental Health Service (CMHS) team based on risk-stratification for depression in older adults. Local committee-guided care was performed after matching a healthy dweller with 4-5 older neighbors included in risk groups. They visited the matched older individuals as often as possible at least once a week using a mood sticker. The CMHS team also conducted a separate case management for older adults with risk-stratified protocols; the higher the risk of suicide, the more intensive was the management, which could include frequent face-to-face visits. High-risk individuals were also referred to the psychiatric service, if deemed necessary.
2. Group-based program was comprised of weekly eight sessions, which were mainly consisted of programs enhancing interpersonal network and group cohesion, and were open to all community-dwelling older adults.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All community-dwelling older adults, aged 65 years and over

Exclusion Criteria

* Subjects who had significant sensory deficits or medical illnesses that would substantially restrict the delivery of the assessment were excluded
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Oh IM, Cho MJ, Hahm BJ, Kim BS, Sohn JH, Suk HW, Jung BY, Kim HJ, Kim HA, Choi KB, You DH, Lim AR, Park IO, Ahn JH, Lee H, Kim YH, Kim MR, Park JE. Effectiveness of a village-based intervention for depression in community-dwelling older adults: a randomised feasibility study. BMC Geriatr. 2020 Mar 4;20(1):89. doi: 10.1186/s12877-020-1495-2.

Reference Type DERIVED
PMID: 32131745 (View on PubMed)

Other Identifiers

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VILLD

Identifier Type: -

Identifier Source: org_study_id

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