NCT06456775

Brief Summary

Tele-SSM is a pre-post mixed-method study to investigate the feasibility, acceptability and the preliminary efficacy of the support self-management skills intervention for depression delivered from distance. The specific objectives of this research include:

  • Transform the SSM intervention for depression from face-to-face delivery to delivery from distance.
  • Develop an software for intervention management
  • Examine knowledge, attitudes and practices of people with depression toward depression
  • Examine the feasibility, acceptability and preliminary efficacy of the intervention
  • Investigate the cost analysis of Tele-SSM intervention

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2021

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

February 2, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

June 5, 2024

Last Update Submit

June 7, 2024

Conditions

Keywords

depressionsupported self-managementtask-shifting approachmobile healthmental healthVietnam

Outcome Measures

Primary Outcomes (4)

  • Depression

    Measured by PHQ-9 questionnaire

    Pre intervention and up to 12 weeks

  • Acceptability

    Measured by questionnaire and in-depth interviews

    Up to 12 weeks after pre-intervention survey

  • Feasiblity

    Measured by questionnaire and in-depth interviews

    Up to 12 weeks after pre-intervention survey

  • Cost

    Measured by financial reports

    Through study completion, an average 6 months

Secondary Outcomes (6)

  • Anxiety

    Pre intervention and up to 12 weeks

  • Stress

    Pre intervention and up to 12 weeks

  • Self-esteem

    Pre intervention and up to 12 weeks

  • Social support

    Pre intervention and up to 12 weeks

  • Health related quality of life

    Pre intervention and up to 12 weeks

  • +1 more secondary outcomes

Study Arms (1)

Single arm

EXPERIMENTAL

All participants in the study received a supported self-management intervention for depression delivered from distance.

Behavioral: Tele-SSM

Interventions

Tele-SSMBEHAVIORAL

Tele-SSM an individual-level psychosocial intervention based on cognitive behavior therapy principles and non-violent communication. The intervention consists of the following 10 sessions delivered through 10 weekly coaching calls delivered by Zoom (audio only).

Single arm

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged from 18-64 years
  • Have a score of PHQ-9 (26) greater than 5.

You may not qualify if:

  • Any participants with severe mental health problems i.e. schizophrenia, bipolar disorder, recent suicide attempts and/or with suicide plans were excluded (current suicide ideation, but without recent suicide attempts and/or with suicide plans were not excluded).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Social Development Studies

Hanoi, 10000, Vietnam

Location

Related Publications (14)

  • Konig H, Konig HH, Konnopka A. The excess costs of depression: a systematic review and meta-analysis. Epidemiol Psychiatr Sci. 2019 Apr 5;29:e30. doi: 10.1017/S2045796019000180.

    PMID: 30947759BACKGROUND
  • Christensen MK, Lim CCW, Saha S, Plana-Ripoll O, Cannon D, Presley F, Weye N, Momen NC, Whiteford HA, Iburg KM, McGrath JJ. The cost of mental disorders: a systematic review. Epidemiol Psychiatr Sci. 2020 Aug 18;29:e161. doi: 10.1017/S204579602000075X.

    PMID: 32807256BACKGROUND
  • Cuijpers P, Noma H, Karyotaki E, Cipriani A, Furukawa TA. Effectiveness and Acceptability of Cognitive Behavior Therapy Delivery Formats in Adults With Depression: A Network Meta-analysis. JAMA Psychiatry. 2019 Jul 1;76(7):700-707. doi: 10.1001/jamapsychiatry.2019.0268.

    PMID: 30994877BACKGROUND
  • Cuijpers P, Karyotaki E, Reijnders M, Purgato M, Barbui C. Psychotherapies for depression in low- and middle-income countries: a meta-analysis. World Psychiatry. 2018 Feb;17(1):90-101. doi: 10.1002/wps.20493.

    PMID: 29352530BACKGROUND
  • Bilsker D, Goldner EM, Anderson E. Supported self-management: a simple, effective way to improve depression care. Can J Psychiatry. 2012 Apr;57(4):203-9. doi: 10.1177/070674371205700402.

    PMID: 22480584BACKGROUND
  • Linde K, Sigterman K, Kriston L, Rucker G, Jamil S, Meissner K, Schneider A. Effectiveness of psychological treatments for depressive disorders in primary care: systematic review and meta-analysis. Ann Fam Med. 2015 Jan-Feb;13(1):56-68. doi: 10.1370/afm.1719.

    PMID: 25583894BACKGROUND
  • Pasarelu CR, Andersson G, Bergman Nordgren L, Dobrean A. Internet-delivered transdiagnostic and tailored cognitive behavioral therapy for anxiety and depression: a systematic review and meta-analysis of randomized controlled trials. Cogn Behav Ther. 2017 Jan;46(1):1-28. doi: 10.1080/16506073.2016.1231219. Epub 2016 Oct 7.

    PMID: 27712544BACKGROUND
  • Chau LW, Murphy J, Nguyen VC, Lou H, Khanh H, Thu T, Minas H, O'Neil J. Lay social workers implementing a task-sharing approach to managing depression in Vietnam. Int J Ment Health Syst. 2021 May 29;15(1):52. doi: 10.1186/s13033-021-00478-8.

    PMID: 34051848BACKGROUND
  • Connolly SM, Vanchu-Orosco M, Warner J, Seidi PA, Edwards J, Boath E, Irgens AC. Mental health interventions by lay counsellors: a systematic review and meta-analysis. Bull World Health Organ. 2021 Aug 1;99(8):572-582. doi: 10.2471/BLT.20.269050. Epub 2021 Apr 29.

    PMID: 34354312BACKGROUND
  • 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: 32071614BACKGROUND
  • Richards D, Richardson T. Computer-based psychological treatments for depression: a systematic review and meta-analysis. Clin Psychol Rev. 2012 Jun;32(4):329-42. doi: 10.1016/j.cpr.2012.02.004. Epub 2012 Feb 28.

    PMID: 22466510BACKGROUND
  • 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: 28476148BACKGROUND
  • Tran NK, Ngo TT, Nguyen TK, Murphy JK, Dang HM. Feasibility, acceptability, and preliminary efficacy of a telehealth supported self-management intervention for adults with depression symptoms in Vietnam: a mixed-method pre-post study. Pilot Feasibility Stud. 2025 Dec 10. doi: 10.1186/s40814-025-01750-1. Online ahead of print.

  • Tran NK, Nguyen QT, Nguyen TK, Hoang MV, Kane S, Dang HM. Knowledge, attitudes, and practices toward depression among people living with depression in Vietnam: the cultural dynamics in the era of globalization. BMC Psychol. 2025 Aug 29;13(1):983. doi: 10.1186/s40359-025-03281-z.

MeSH Terms

Conditions

DepressionPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single Group: Clinical trials with a single arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Division

Study Record Dates

First Submitted

June 5, 2024

First Posted

June 13, 2024

Study Start

February 2, 2021

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

The data of this study are available on request from the principal investigator after the outcomes of the study are published. .

Shared Documents
SAP, ICF, CSR
Time Frame
The data is available upon request after the outcomes of the study are published.
Access Criteria
Researchers must sign a Data Use Agreement specifying the terms and conditions of data usage, including confidentiality, data security measures, and prohibitions on unauthorized data sharing. Researchers must be affiliated with a recognized academic, governmental, or non-profit research institution. Proof of institutional affiliation may be required.esearchers must adhere to ethical guidelines and legal regulations governing data protection and privacy. Data should be used for the purposes outlined in the approved agreement.

Available IPD Datasets

Individual Participant Data Set Access

Locations