Village-based Intervention for Late-life Depression
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|ClinicalTrials.gov Identifier: NCT04013165|
Recruitment Status : Completed
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Active control Behavioral: Village-based intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A community-based randomized controlled pilot study|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Village-based Intervention for Depression in Community-dwelling Older Adults: a Randomized Controlled Pilot Study|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2018|
Active Comparator: Active control
Usual care of the Community Mental Health Service
Behavioral: 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.
Experimental: Village-based intervention
Individual-based case management + group-based program
Behavioral: Village-based intervention
- Changes from baseline Korean version of the short form of Geriatric Depression Scale (SGDS-K) after intervention [ Time Frame: baseline, after intervention (up to 24 weeks) ]The SGDS-K was developed for evaluating depressive symptoms of older adults; higher score means to have more depressive symptoms (lowest 0 - highest 15)
- Incidental depressive episode after intervention [ Time Frame: baseline, after intervention (up to 24 weeks) ]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 [ Time Frame: baseline, after intervention (up to 24 weeks) ]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 [ Time Frame: baseline, after intervention (up to 24 weeks) ]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 [ Time Frame: baseline, after intervention (up to 24 weeks) ]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 [ Time Frame: baseline, after intervention (up to 24 weeks) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013165
|Korea, Republic of|
|Seoul National University College of Medicine|
|Seoul, Korea, Republic of, 110-744|