Village-based Intervention for Late-life Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04013165
• Other study ID #: VILLD
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• Village-based intervention
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline, after intervention (up to 24 weeks)
Secondary	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)	baseline, after intervention (up to 24 weeks)
Secondary	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.	baseline, after intervention (up to 24 weeks)
Secondary	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).	baseline, after intervention (up to 24 weeks)
Secondary	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).	baseline, after intervention (up to 24 weeks)
Secondary	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).	baseline, after intervention (up to 24 weeks)