Tele-SSM: A Telephone Technology Innovation in the Intervention on Supported Self-management for Depression in Vietnam

Depression Clinical Trial

Official title:

Tele-SSM: A Telephone Technology Innovation in the Intervention on Supported Self-management for Depression in Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06456775
• Other study ID #: NCUD.05-2019.29
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: June 2024
• Source: Institute for Social Development Studies, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Introduction

In the context of limited interventions for depression in Vietnam and the strong potential for tele-health to improve accessibility to mental health care in low-middle income countries, the principal investigators conducted a pre-post mixed-method study of a supported self-management for depression delivered from distance (Tele-SSM) to evaluate the preliminary efficacy, feasibility and acceptability of this approach on depression and other mental health outcomes for adults with depression symptoms in Vietnam and to explore knowledge, attitudes and practices of people with depression towards depression.

Method

This is pre-post mixed method study. The princial investigators use both quantitative and quanlitative methodology to evaluate the preliminary efficacy, feasibility and acceptability of Tele-SSM intervention on depression and other mental health outcomes for adults with depression symptoms in Vietnam and to explore knowledge, attitudes and practices of people with depression towards depression.

Recruitment

Participants ages 18-64 years ared recruited online through social media from May 2022 and May 2023. Interested participants completed the PHQ-9 on Kobotoolbox. Potential participants who satisfy the eligibility criteria of the study provided contact information. A research assistant with a psychology background conducted a video call with each potential participant to confirm their eligibility, provide information about the study and the intervention. Informed consent was obtained from all individual participants included in the study.

All procedures performed in studies involving human participants are in accordance with the ethical standards of the institutional ethical committee and was approved by the Institutional Review Board at ISDS (IRB00011703) on 05th May 2021 in Hanoi.

Sample size considerations

Findings from meta-analytic studies examining the effect of CBT interventions indicate the effect size for CBT on depressive symptoms to be 0.53 (Cuijpers et al., 2013) and on health-related quality of life to be 0.63 (Hofmann et al., 2017). Sample size calculations indicated that a sample size of 52 participants was sufficient to detect a conservative anticipated effect size of 0.40, with a statistical power of 80% and a two-sided alpha level of 0.05. The target sample size was increased to 72, assuming an anticipated attrition rate of 20%. In reality, the principal investigators recruited 75 patients, with 58 patients completing the intervention.

Data management

• Participants completed pre- and post-questionnaires online using Kobotoolbox. The in-depth interviews are audio-recorded. Audio recordings are transcribed. Participant records are managed by a secured website.

Data Analysis Plan

• Qualitative analysis methods: The IDIs are audio-recorded, transcribed and analyzed thematically to identify significant themes, patterns, and potential correlational relationships. The analysis is conducted with Excel software.

• Quantitative analysis method: The principal investigators calculate descriptive statistics for all variables (means, ranges, standard deviations, percent data missing, and frequencies for categorical variables). For continuous variables, the principal investigators conduct statiscial tests to test for differences before and after intervention. For the acceptability, frequencies for questions on satisfaction were calculated from endline data.

• Cost analysis method: The principal investigators analyze all costs incurred from activities of Tele-SSM intervention for all participants in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Adults aged from 18-64 years

• Have a score of PHQ-9 (26) greater than 5.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Tele-SSM
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).

Locations

Country	Name	City	State
Vietnam	Institute for Social Development Studies	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Social Development Studies, Vietnam	National Foundation for Science & Technology Development, Vietnam

Country where clinical trial is conducted

Vietnam, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA Psychiatry. 2019 Jul 17;: JAMA Psychiatry. 2022 Feb 1;79(2):180. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Measured by PHQ-9 questionnaire	Pre intervention and up to 12 weeks
Primary	Acceptability	Measured by questionnaire and in-depth interviews	Up to 12 weeks after pre-intervention survey
Primary	Feasiblity	Measured by questionnaire and in-depth interviews	Up to 12 weeks after pre-intervention survey
Primary	Cost	Measured by financial reports	Through study completion, an average 6 months
Secondary	Anxiety	Measure by DASS-21 questionnaire	Pre intervention and up to 12 weeks
Secondary	Stress	Measured by DASS-21 questionnaire	Pre intervention and up to 12 weeks
Secondary	Self-esteem	Measured by Rosenberg self - Esteem scale	Pre intervention and up to 12 weeks
Secondary	Social support	Measured by Multidimensional Scale of Perceived Social Support (MSPSS)	Pre intervention and up to 12 weeks
Secondary	Health related quality of life	Measured by SF-12 and EQ-5D-5L questionnaire	Pre intervention and up to 12 weeks
Secondary	Knowledge, attitude and practices of people with depression	Measured by in-depth interviews	Pre-intervention