NCT04013165

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
Last Updated

July 9, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

July 4, 2019

Last Update Submit

July 7, 2019

Conditions

Keywords

Old-agedCommunity-based interventionLate-life depressionSuicide

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline Korean version of the short form of Geriatric Depression Scale (SGDS-K) after intervention

    The SGDS-K was developed for evaluating depressive symptoms of older adults; higher score means to have more depressive symptoms (lowest 0 - highest 15)

    baseline, after intervention (up to 24 weeks)

Secondary Outcomes (5)

  • Incidental depressive episode after intervention

    baseline, after intervention (up to 24 weeks)

  • Incidental suicidal ideation, plans, or attempts after intervention

    baseline, after intervention (up to 24 weeks)

  • Changes from baseline Korean version of Lubben Social Network Scale (K-LSNS) after intervention

    baseline, after intervention (up to 24 weeks)

  • Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) after intervention

    baseline, after intervention (up to 24 weeks)

  • Changes from baseline Korean version of the Mini-Mental State Examination (MMSE-KC) after intervention

    baseline, after intervention (up to 24 weeks)

Study Arms (2)

Active control

ACTIVE COMPARATOR

Usual care of the Community Mental Health Service

Behavioral: Active control

Village-based intervention

EXPERIMENTAL

Individual-based case management + group-based program

Behavioral: Village-based intervention

Interventions

Active controlBEHAVIORAL

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.

Active control

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.

Village-based intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects who had significant sensory deficits or medical illnesses that would substantially restrict the delivery of the assessment were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University College of Medicine

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionSuicide

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A community-based randomized controlled pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 9, 2019

Study Start

June 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

July 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations