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临床试验/NCT04013165
NCT04013165已完成不适用

Effectiveness of a Village-based Intervention for Depression in Community-dwelling Older Adults: a Randomized Controlled Pilot Study

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Changes from baseline Korean version of the short form of Geriatric Depression Scale (SGDS-K) after intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Active control

Active Comparator

Usual care of the Community Mental Health Service

干预措施: Active control (Behavioral)

Village-based intervention

Experimental

Individual-based case management + group-based program

干预措施: Village-based intervention (Behavioral)

结局指标

主要结局

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

时间窗: 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)

次要结局

  • 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))
  • 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 the Mini-Mental State Examination (MMSE-KC) after intervention(baseline, after intervention (up to 24 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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