Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595485
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Project Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents
For this project we adopted Kabat-Zinns definition of mindfulness as the intentional and non-judgmental awareness of thoughts feelings and sensations that specifically occur in the present moment Kabat-Zinn 2003 We hope to help depressed Thai adolescents begin to develop mindfulness as part of their habitual attention and hone present-moment awareness through mindfulness practicing For their practice they will be taught to maintain an awareness of their thoughts emotions and physical sensations and relate these to the negative thoughts that typically contribute to the onset of their depression We believe this will help Thai adolescents better understand the relationship between their thoughts and their depressive symptoms Once they understand these relationships their practice will help them become more flexible reasonable and positive
This project will consist of two phases Phase I Using the established literature and qualitative interviews and focus groups we will design and pilot test an online MBI In Phase II we will evaluate the effectiveness of the online MBI by randomizing depressed Thai adolescent volunteers into one of two groups an online MBI intervention group and a usual care waitlist control group N182 Depression grade well-being and mindfulness will be measure at four-time points baseline immediately post-intervention and 3- and 6-months post-intervention
For this project we adopted Kabat-Zinns definition of mindfulness as the intentional and non-judgmental awareness of thoughts feelings and sensations that specifically occur in the present moment Kabat-Zinn 2003 We hope to help depressed Thai adolescents begin to develop mindfulness as part of their habitual attention and hone present-moment awareness through mindfulness practicing For their practice they will be taught to maintain an awareness of their thoughts emotions and physical sensations and relate these to the negative thoughts that typically contribute to the onset of their depression We believe this will help Thai adolescents better understand the relationship between their thoughts and their depressive symptoms Once they understand these relationships their practice will help them become more flexible reasonable and positive
This project will consist of two phases Phase I Using the established literature and qualitative interviews and focus groups we will design and pilot test an online MBI In Phase II we will evaluate the effectiveness of the online MBI by randomizing depressed Thai adolescent volunteers into one of two groups an online MBI intervention group and a usual care waitlist control group N182 Depression grade well-being and mindfulness will be measure at four-time points baseline immediately post-intervention and 3- and 6-months post-intervention
Detailed Description:
Phase I To develop and pilot test an online mindfulness-based intervention
10 depressed adolescents for in-depth interviews and 10 stakeholders 2 teachers 3 school health providersnurses 2 mental health and psychiatric instructors and 3 parents of adolescents for focus groups to develop and customize the online MBI to adolescents
20 depressed adolescents randomized to two groups 10 each to pilot test the study for phase II
Phase II To evaluate the effects of the online MBI on depressive symptoms mindfulness grade and well-being among depressed Thai adolescents
Quantitative sample 182 Thai-adolescents with depression randomized to two groups 91 each to test the effectiveness and efficacy of the online MBI
Qualitative sample 20 Thai adolescents with depression for in-depth interview and focus group to get the adolescents perceptions of the effectiveness of the online MBI
10 depressed adolescents for in-depth interviews and 10 stakeholders 2 teachers 3 school health providersnurses 2 mental health and psychiatric instructors and 3 parents of adolescents for focus groups to develop and customize the online MBI to adolescents
20 depressed adolescents randomized to two groups 10 each to pilot test the study for phase II
Phase II To evaluate the effects of the online MBI on depressive symptoms mindfulness grade and well-being among depressed Thai adolescents
Quantitative sample 182 Thai-adolescents with depression randomized to two groups 91 each to test the effectiveness and efficacy of the online MBI
Qualitative sample 20 Thai adolescents with depression for in-depth interview and focus group to get the adolescents perceptions of the effectiveness of the online MBI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None