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

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ClinicalTrials.gov Identifier: NCT03001063
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : May 27, 2022
Sponsor:
Collaborators:
Grand Challenges Canada
Ministry of Labour - Invalids and Social Affairs
Information provided by (Responsible Party):
John O'Neil, Simon Fraser University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Depression Other: Supported Self-Management Other: Enhanced treatment as usual Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mental Health in Adults and Children: Frugal Innovations
Study Start Date : March 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Self-Reporting Questionnaire 20 (SRQ-20) [ Time Frame: Two months ]

Secondary Outcome Measures :
  1. World Health Organization's Disability Assessment Scale (WHODAS 2.0) [ Time Frame: Two months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001063


Locations
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Vietnam
Institute of Population, Health and Development
Hanoi, Vietnam
Sponsors and Collaborators
Simon Fraser University
Grand Challenges Canada
Ministry of Labour - Invalids and Social Affairs
Investigators
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Principal Investigator: John O'Neil, PhD Simon Fraser University
Principal Investigator: Vu Cong Nguyen, MD Institute of Population, Health and Development
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: John O'Neil, Dean, Faculty of Health Sciences, Simon Fraser University
ClinicalTrials.gov Identifier: NCT03001063    
Other Study ID Numbers: 0762-05
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders