Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456775
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Brief Title:
Tele-SSM A Telephone Technology Innovation in the Intervention on Supported Self-management for Depression in Vietnam
Sponsor:
Institute for Social Development Studies Vietnam
Organization:
Institute for Social Development Studies Vietnam
Study Overview
Official Title:
Tele-SSM A Telephone Technology Innovation in the Intervention on Supported Self-management for Depression in Vietnam
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 053 Cuijpers et al 2013 and on health-related quality of life to be 063 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 040 with a statistical power of 80 and a two-sided alpha level of 005 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
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 053 Cuijpers et al 2013 and on health-related quality of life to be 063 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 040 with a statistical power of 80 and a two-sided alpha level of 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None