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出境医 / 临床实验 / Village-based Intervention for Late-life Depression

Village-based Intervention for Late-life Depression

Study Description
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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Active control Behavioral: Village-based intervention Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A community-based randomized controlled pilot study
Masking: None (Open Label)
Primary Purpose: Prevention
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
Arms and Interventions
Arm Intervention/treatment
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
  1. 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.
  2. 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.
Outcome Measures
Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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).

  4. 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).

  5. 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).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE July 4, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2019) 		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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2019)
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Village-based Intervention for Late-life Depression
Official Title  ICMJE Effectiveness of a Village-based Intervention for Depression in Community-dwelling Older Adults: a Randomized Controlled Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A community-based randomized controlled pilot study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • 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.
  • Behavioral: Village-based intervention
    1. 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.
    2. 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.
Study Arms  ICMJE
  • Active Comparator: Active control
    Usual care of the Community Mental Health Service
    Intervention: Behavioral: Active control
  • Experimental: Village-based intervention
    Individual-based case management + group-based program
    Intervention: Behavioral: Village-based intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2019) 		160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 31, 2018
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013165
Other Study ID Numbers  ICMJE VILLD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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