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

Status Completed

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT06456775
• Study type: Interventional
• Source: Institute for Social Development Studies, Vietnam
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Completion date: August 30, 2023