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Mental Health in Adults and Children- Frugal Innovations (MAC-FI): Adult Depression Component (MAC-FI)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Supported Self-Management
Enhanced treatment as usual
Sponsored by
Simon Fraser University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Score of >7 on SRQ-20 indicating depression caseness
  • Consent to participate and complete all measures

Exclusion Criteria:

  • Cognitive disturbance
  • Psychotic symptoms

Sites / Locations

  • Institute of Population, Health and Development

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

This arm will receive the Supported Self- Management intervention, which consists of bibliotherapy that is provided with the regular support of health or social workers for a duration of two months.

This arm will receive enhanced treatment as usual, which consists of a leaflet with information about depression and regular care as provided by primary care centres. The control arm will receive the intervention after the intervention arm has completed the intervention period.

Outcomes

Primary Outcome Measures

Self-Reporting Questionnaire 20 (SRQ-20)

Secondary Outcome Measures

World Health Organization's Disability Assessment Scale (WHODAS 2.0)

Full Information

First Posted
December 20, 2016
Last Updated
May 26, 2022
Sponsor
Simon Fraser University
Collaborators
Grand Challenges Canada, Ministry of Labour - Invalids and Social Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT03001063
Brief Title
Mental Health in Adults and Children- Frugal Innovations (MAC-FI): Adult Depression Component
Acronym
MAC-FI
Official Title
Mental Health in Adults and Children: Frugal Innovations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Simon Fraser University
Collaborators
Grand Challenges Canada, Ministry of Labour - Invalids and Social Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This stepped wedge, randomized controlled trial will test the effectiveness of a Supported Self-Management intervention for depression among adults in Vietnam. The intervention will be delivered at the community level in 8 Vietnamese provinces by primary care providers and social workers. The intervention group will receive the Supported Self-Management intervention, while the control group will receive enhanced treatment as usual. The primary outcome measure for depression is the Self-Reporting Questionnaire-20 (SRQ-20). The World Health Organization's Disability Assessment Scale (WHODAS 2.00 and the CAGE (Concern/Cut-down, Anger, Guilt, and Eye-opener) measures are also used to assess functional ability and alcohol misuse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
376 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm will receive the Supported Self- Management intervention, which consists of bibliotherapy that is provided with the regular support of health or social workers for a duration of two months.
Arm Title
Control
Arm Type
Other
Arm Description
This arm will receive enhanced treatment as usual, which consists of a leaflet with information about depression and regular care as provided by primary care centres. The control arm will receive the intervention after the intervention arm has completed the intervention period.
Intervention Type
Other
Intervention Name(s)
Supported Self-Management
Intervention Description
This Supported Self-Management intervention consists of bibliotherapy (the Antidepressant Skills Workshop) that is provided to a patient by a health or social worker. The patient is supported in the use of the skills found in the workbook over the course of two months. The skills in the workbook are based on the principles of Cognitive Behavioural Therapy.
Intervention Type
Other
Intervention Name(s)
Enhanced treatment as usual
Intervention Description
Participants in the control arm will received enhanced treatment as usual in the form of usual care at primary care centres and a leaflet providing information about depression.
Primary Outcome Measure Information:
Title
Self-Reporting Questionnaire 20 (SRQ-20)
Time Frame
Two months
Secondary Outcome Measure Information:
Title
World Health Organization's Disability Assessment Scale (WHODAS 2.0)
Time Frame
Two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Score of >7 on SRQ-20 indicating depression caseness Consent to participate and complete all measures Exclusion Criteria: Cognitive disturbance Psychotic symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O'Neil, PhD
Organizational Affiliation
Simon Fraser University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vu Cong Nguyen, MD
Organizational Affiliation
Institute of Population, Health and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Population, Health and Development
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
32071614
Citation
Murphy JK, Xie H, Nguyen VC, Chau LW, Oanh PT, Nhu TK, O'Neil J, Goldsmith CH, Van Hoi N, Ma Y, Lou H, Jones W, Minas H. Is supported self-management for depression effective for adults in community-based settings in Vietnam?: a modified stepped-wedge cluster randomized controlled trial. Int J Ment Health Syst. 2020 Feb 12;14:8. doi: 10.1186/s13033-020-00342-1. eCollection 2020.
Results Reference
derived
PubMed Identifier
28476148
Citation
Murphy J, Goldsmith CH, Jones W, Oanh PT, Nguyen VC. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):209. doi: 10.1186/s13063-017-1924-5.
Results Reference
derived

Learn more about this trial

Mental Health in Adults and Children- Frugal Innovations (MAC-FI): Adult Depression Component

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