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

Depression Clinical Trial

— MAC-FI  

Official title:

Mental Health in Adults and Children: Frugal Innovations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001063
• Other study ID #: 0762-05
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: May 2022
• Source: Simon Fraser University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Cognitive disturbance
• Psychotic symptoms

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Vietnam	Institute of Population, Health and Development	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
Simon Fraser University	Grand Challenges Canada, Ministry of Labour - Invalids and Social Affairs

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reporting Questionnaire 20 (SRQ-20)		Two months
Secondary	World Health Organization's Disability Assessment Scale (WHODAS 2.0)		Two months