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Village-based Intervention for Late-life Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active control
Village-based intervention
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Old-aged, Community-based intervention, Late-life depression, Suicide

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active control

Village-based intervention

Arm Description

Usual care of the Community Mental Health Service

Individual-based case management + group-based program

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Incidental depressive episode after intervention
Major or minor depressive episode was diagnosed based on the Diagnostic and Statistical Manual of Mental Disorders, the fourth edition (DSM-IV) using a structured clinical interview, the Korean Version of the Composite International Diagnostic Interview (K-CIDI)
Incidental suicidal ideation, plans, or attempts after intervention
Multisite Intervention Study on Suicidal Behaviours (SUPRE-MISS) was used to assess of having suicidal ideation, plans, or attempts.
Changes from baseline Korean version of Lubben Social Network Scale (K-LSNS) after intervention
The Lubben Social Network Scale (LSNS) was developed for evaluating older adults' social interaction with their relatives and friends; higher score means to have stronger social network (lowest 0 - highest 50).
Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) after intervention
Seoul-Instrumental Activities of Daily Living (S-IADL) was developed to assess elderly person's instrumental everyday activities; higher score means to have worse daily function (lowest 0 - highest 45).
Changes from baseline Korean version of the Mini-Mental State Examination (MMSE-KC) after intervention
Mini-Mental State Examination in the Korean version of the CERAD assessment packet (MMSE-KC) is a well-known screening tool for global cognitive function that measures orientation, language (repetition, naming, reading and writing), concentration, constructional praxis, and memory; higher score means to have better global cognitive function (lowest 0 - highest 30).

Full Information

First Posted
July 4, 2019
Last Updated
July 7, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04013165
Brief Title
Village-based Intervention for Late-life Depression
Official Title
Effectiveness of a Village-based Intervention for Depression in Community-dwelling Older Adults: a Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
March 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Old-aged, Community-based intervention, Late-life depression, Suicide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A community-based randomized controlled pilot study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active control
Arm Type
Active Comparator
Arm Description
Usual care of the Community Mental Health Service
Arm Title
Village-based intervention
Arm Type
Experimental
Arm Description
Individual-based case management + group-based program
Intervention Type
Behavioral
Intervention Name(s)
Active control
Intervention Description
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
Intervention Name(s)
Village-based intervention
Intervention Description
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. 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.
Primary Outcome Measure Information:
Title
Changes from baseline Korean version of the short form of Geriatric Depression Scale (SGDS-K) after intervention
Description
The SGDS-K was developed for evaluating depressive symptoms of older adults; higher score means to have more depressive symptoms (lowest 0 - highest 15)
Time Frame
baseline, after intervention (up to 24 weeks)
Secondary Outcome Measure Information:
Title
Incidental depressive episode after intervention
Description
Major or minor depressive episode was diagnosed based on the Diagnostic and Statistical Manual of Mental Disorders, the fourth edition (DSM-IV) using a structured clinical interview, the Korean Version of the Composite International Diagnostic Interview (K-CIDI)
Time Frame
baseline, after intervention (up to 24 weeks)
Title
Incidental suicidal ideation, plans, or attempts after intervention
Description
Multisite Intervention Study on Suicidal Behaviours (SUPRE-MISS) was used to assess of having suicidal ideation, plans, or attempts.
Time Frame
baseline, after intervention (up to 24 weeks)
Title
Changes from baseline Korean version of Lubben Social Network Scale (K-LSNS) after intervention
Description
The Lubben Social Network Scale (LSNS) was developed for evaluating older adults' social interaction with their relatives and friends; higher score means to have stronger social network (lowest 0 - highest 50).
Time Frame
baseline, after intervention (up to 24 weeks)
Title
Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) after intervention
Description
Seoul-Instrumental Activities of Daily Living (S-IADL) was developed to assess elderly person's instrumental everyday activities; higher score means to have worse daily function (lowest 0 - highest 45).
Time Frame
baseline, after intervention (up to 24 weeks)
Title
Changes from baseline Korean version of the Mini-Mental State Examination (MMSE-KC) after intervention
Description
Mini-Mental State Examination in the Korean version of the CERAD assessment packet (MMSE-KC) is a well-known screening tool for global cognitive function that measures orientation, language (repetition, naming, reading and writing), concentration, constructional praxis, and memory; higher score means to have better global cognitive function (lowest 0 - highest 30).
Time Frame
baseline, after intervention (up to 24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University College of Medicine
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32131745
Citation
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.
Results Reference
derived

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Village-based Intervention for Late-life Depression

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