An interventional study of Active control and Village-based intervention in Depression, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 160 is above the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Usual care of the Community Mental Health Service
Behavioral: Active control
Individual-based case management + group-based program
Behavioral: Village-based intervention
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.
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.
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)
Time frame: baseline, after intervention (up to 24 weeks)
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)
Time frame: baseline, after intervention (up to 24 weeks)
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.
Time frame: baseline, after intervention (up to 24 weeks)
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).
Time frame: baseline, after intervention (up to 24 weeks)
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).
Time frame: baseline, after intervention (up to 24 weeks)
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).
Time frame: baseline, after intervention (up to 24 weeks)
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital