Depression Clinical Trial
Official title:
Effectiveness of a Village-based Intervention for Depression in Community-dwelling Older Adults: a Randomized Controlled Pilot Study
NCT number | NCT04013165 |
Other study ID # | VILLD |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | March 31, 2018 |
Verified date | May 2019 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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) |
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