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

May 26, 2022 updated by: John O'Neil, Simon Fraser University

Mental Health in Adults and Children: Frugal Innovations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Institute of Population, Health and Development

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Cognitive disturbance
  • Psychotic symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Other: Supported Self-Management
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.
Other: Control
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.
Other: Enhanced treatment as usual
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-Reporting Questionnaire 20 (SRQ-20)
Time Frame: Two months
Two months

Secondary Outcome Measures

Outcome Measure
Time Frame
World Health Organization's Disability Assessment Scale (WHODAS 2.0)
Time Frame: Two months
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simon Fraser University

Collaborators

Grand Challenges Canada
Ministry of Labour - Invalids and Social Affairs

Investigators

  • Principal Investigator: John O'Neil, PhD, Simon Fraser University
  • Principal Investigator: Vu Cong Nguyen, MD, Institute of Population, Health and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 20, 2016

First Posted (Estimate)

December 22, 2016

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0762-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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