We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
Trial record 36 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03001063
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : December 23, 2016
Information provided by (Responsible Party):

December 20, 2016
December 22, 2016
December 23, 2016
March 2016
January 2019   (Final data collection date for primary outcome measure)
Self-Reporting Questionnaire 20 (SRQ-20) [ Time Frame: Two months ]
Self-Reporting Questionnaire 20 [ Time Frame: Two months ]
Complete list of historical versions of study NCT03001063 on ClinicalTrials.gov Archive Site
World Health Organization's Disability Assessment Scale (WHODAS 2.0) [ Time Frame: Two months ]
WHODAS 2.0 [ Time Frame: Two months ]
Not Provided
Not Provided
Mental Health in Adults and Children- Frugal Innovations (MAC-FI): Adult Depression Component
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.
Not Provided
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • 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: 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.
  • 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.
    Intervention: Other: Supported Self-Management
  • 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.
    Intervention: Other: Enhanced treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2019
January 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Cognitive disturbance
  • Psychotic symptoms
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Jill Murphy, PhD 778-782-3844 jgmurphy@sfu.ca
Contact: Rebecca Zappelli, BA 778-782-9800 rzappell@sfu.ca
Not Provided
Not Provided
John O'Neil, Simon Fraser University
Simon Fraser University
  • Grand Challenges Canada
  • Ministry of Labour, Invalids and Social Affairs (MOLISA): Vietnam
Principal Investigator: John O'Neil, PhD Simon Fraser University
Principal Investigator: Vu Cong Nguyen, MD Institute of Population, Health and Development
Simon Fraser University
December 2016

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