Clinical trial NCT04013165: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Old-aged
Community-based intervention
Late-life depression
Suicide
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 160
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A community-based randomized controlled pilot study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes from baseline Korean version of the short form of Geriatric Depression Scale (SGDS-K) after intervention
timeFrame: baseline, after intervention (up to 24 weeks)
Secondary outcomes:
measure: Incidental depressive episode after intervention
timeFrame: baseline, after intervention (up to 24 weeks)
measure: Incidental suicidal ideation, plans, or attempts after intervention
timeFrame: baseline, after intervention (up to 24 weeks)
measure: Changes from baseline Korean version of Lubben Social Network Scale (K-LSNS) after intervention
timeFrame: baseline, after intervention (up to 24 weeks)
measure: Changes from baseline Seoul-Instrumental Activities of Daily Living (S-IADL) after intervention
timeFrame: baseline, after intervention (up to 24 weeks)
measure: Changes from baseline Korean version of the Mini-Mental State Examination (MMSE-KC) after intervention
timeFrame: baseline, after intervention (up to 24 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
Study officials:
References:
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.