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

June 7, 2024 updated by: Tran Kieu Nhu, Institute for Social Development Studies, Vietnam

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 10000
        • Institute for Social Development Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
All participants in the study received a supported self-management intervention for depression delivered from distance.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Pre intervention and up to 12 weeks
Measured by PHQ-9 questionnaire
Pre intervention and up to 12 weeks
Acceptability
Time Frame: Up to 12 weeks after pre-intervention survey
Measured by questionnaire and in-depth interviews
Up to 12 weeks after pre-intervention survey
Feasiblity
Time Frame: Up to 12 weeks after pre-intervention survey
Measured by questionnaire and in-depth interviews
Up to 12 weeks after pre-intervention survey
Cost
Time Frame: Through study completion, an average 6 months
Measured by financial reports
Through study completion, an average 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Pre intervention and up to 12 weeks
Measure by DASS-21 questionnaire
Pre intervention and up to 12 weeks
Stress
Time Frame: Pre intervention and up to 12 weeks
Measured by DASS-21 questionnaire
Pre intervention and up to 12 weeks
Self-esteem
Time Frame: Pre intervention and up to 12 weeks
Measured by Rosenberg self - Esteem scale
Pre intervention and up to 12 weeks
Social support
Time Frame: Pre intervention and up to 12 weeks
Measured by Multidimensional Scale of Perceived Social Support (MSPSS)
Pre intervention and up to 12 weeks
Health related quality of life
Time Frame: Pre intervention and up to 12 weeks
Measured by SF-12 and EQ-5D-5L questionnaire
Pre intervention and up to 12 weeks
Knowledge, attitude and practices of people with depression
Time Frame: Pre-intervention
Measured by in-depth interviews
Pre-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Social Development Studies, Vietnam

Collaborators

National Foundation for Science & Technology Development, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCUD.05-2019.29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

The data is available upon request after the outcomes of the study are published.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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