NCT03001063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

December 20, 2016

Last Update Submit

May 26, 2022

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Self-Reporting Questionnaire 20 (SRQ-20)

    Two months

Secondary Outcomes (1)

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

    Two months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Supported Self-ManagementOTHER

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.

Intervention
Enhanced treatment as usualOTHER

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cognitive disturbance
  • Psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Population, Health and Development

Hanoi, Vietnam

Location

Related Publications (2)

  • Murphy JK, Xie H, Nguyen VC, Chau LW, Oanh PT, Nhu TK, O'Neil J, Goldsmith CH, Van Hoi N, Ma Y, Lou H, Jones W, Minas H. Is supported self-management for depression effective for adults in community-based settings in Vietnam?: a modified stepped-wedge cluster randomized controlled trial. Int J Ment Health Syst. 2020 Feb 12;14:8. doi: 10.1186/s13033-020-00342-1. eCollection 2020.

    PMID: 32071614DERIVED

  • Murphy J, Goldsmith CH, Jones W, Oanh PT, Nguyen VC. The effectiveness of a Supported Self-management task-shifting intervention for adult depression in Vietnam communities: study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):209. doi: 10.1186/s13063-017-1924-5.

    PMID: 28476148DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • John O'Neil, PhD

    Simon Fraser University

    PRINCIPAL INVESTIGATOR

  • Vu Cong Nguyen, MD

    Institute of Population, Health and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean, Faculty of Health Sciences

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

VN(1)