An interventional study of Tele-SSM in Depression, sponsored by Institute for Social Development Studies, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-06-13.
Sponsored by Institute for Social Development Studies, Vietnam · Not applicable, Interventional, and Supportive care
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:
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
Data Analysis Plan
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 75 is below the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →This is the only study on the registry with Institute for Social Development Studies, Vietnam as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Depression
Measured by PHQ-9 questionnaire
Time frame: Pre intervention and up to 12 weeks
Acceptability
Measured by questionnaire and in-depth interviews
Time frame: Up to 12 weeks after pre-intervention survey
Feasiblity
Measured by questionnaire and in-depth interviews
Time frame: Up to 12 weeks after pre-intervention survey
Cost
Measured by financial reports
Time frame: Through study completion, an average 6 months
Anxiety
Measure by DASS-21 questionnaire
Time frame: Pre intervention and up to 12 weeks
Stress
Measured by DASS-21 questionnaire
Time frame: Pre intervention and up to 12 weeks
Self-esteem
Measured by Rosenberg self - Esteem scale
Time frame: Pre intervention and up to 12 weeks
Social support
Measured by Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Pre intervention and up to 12 weeks
Health related quality of life
Measured by SF-12 and EQ-5D-5L questionnaire
Time frame: Pre intervention and up to 12 weeks
Knowledge, attitude and practices of people with depression
Measured by in-depth interviews
Time frame: Pre-intervention
Plan to share: Yes — The data of this study are available on request from the principal investigator after the outcomes of the study are published. .
Supporting information: Sap, Icf, Csr
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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