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

Mental Health in Adults and Children: Frugal Innovations

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03001063

Acronym

MAC-FI

Enrollment

376

Registered

2016-12-22

Start date

2016-03-31

Completion date

2019-03-31

Last updated

2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

OTHERSupported 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.

OTHEREnhanced 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Cognitive disturbance * Psychotic symptoms

Design outcomes

Primary

Measure	Time frame
Self-Reporting Questionnaire 20 (SRQ-20)	Two months

Secondary

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

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026