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NCT Number: NCT03001063

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Population, Health and Development

Hanoi, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Cognitive disturbance
  • Psychotic symptoms

Treatment and study plan

Supported Self-Management

Other

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

Other

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 outcomes

  1. Self-Reporting Questionnaire 20 (SRQ-20)

    Time frame: Two months

Secondary outcomes

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

    Time frame: Two months

Sponsors and collaborators

Lead sponsor

Simon Fraser University

Other

Collaborators

  • Grand Challenges Canada
  • Ministry of Labour - Invalids and Social Affairs

Registry information

Official study title

Mental Health in Adults and Children: Frugal Innovations

Acronym: MAC-FI

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2016
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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