Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548544
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2020-09-11
Brief Title:
A Randomized Controlled Feasibility Study of Emotional Well-being of Adolescents Undergoing a Mindfulness Training During COVID-19
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Randomized Controlled Feasibility Study of Emotional Well-being of Adolescents Undergoing a Mindfulness Training During the COVID-19 Pandemic
Status:
COMPLETED
Status Verified Date:
2020-09
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:
The COVID-19 pandemic has been significantly affecting peoples lives around the globe Social distancing self-quarantine shelter-in-place measures economic challenges and COVID-19-cased illness and deaths have the potential to significantly impact mental health and cause stress anxiety and depression Adolescents may be especially vulnerable to this situation due to their increased vulnerability to the onset of depression and anxiety in general
One promising approach to reduce anxiety and depression in youth is a neuroscience-based mindfulness intervention Training for Awareness Resilience and Action TARA Henje Blom et al 2014 TARA is usually delivered over 12 weeks by two facilitators in groups of 10-15 adolescents in-person and it has been shown to reduce symptoms of depression and anxiety in depressed adolescents Henje Blom et al 2016 and modify brain properties Yuan et al 2020 The TARA intervention can also be delivered remotely Other types of therapy delivered remotely such as internet-based cognitive behavioral therapy have shown comparable efficiency to face-to-face delivery Carlbring et al 2017
The objective of this study is to utilize an individually randomized group treatment open-label waitlist-controlled clinical trial to test the feasibility of TARA delivered partially over Zoom in improving the self-reported emotional well-being primary outcome emotional problems measured with the Strengths and Difficulties Questionnaire SDQ in healthy adolescents between the ages of 14 to 18 years old during the COVID-19 pandemic
Our central hypothesis is that emotional well-being of adolescents in the intervention group will improve stronger or deteriorate less than in the control group We will test this hypothesis in 21 adolescents randomized to the TARA intervention partially delivered over Zoom 12 adolescents or to the waitlist control group 9 adolescents
One promising approach to reduce anxiety and depression in youth is a neuroscience-based mindfulness intervention Training for Awareness Resilience and Action TARA Henje Blom et al 2014 TARA is usually delivered over 12 weeks by two facilitators in groups of 10-15 adolescents in-person and it has been shown to reduce symptoms of depression and anxiety in depressed adolescents Henje Blom et al 2016 and modify brain properties Yuan et al 2020 The TARA intervention can also be delivered remotely Other types of therapy delivered remotely such as internet-based cognitive behavioral therapy have shown comparable efficiency to face-to-face delivery Carlbring et al 2017
The objective of this study is to utilize an individually randomized group treatment open-label waitlist-controlled clinical trial to test the feasibility of TARA delivered partially over Zoom in improving the self-reported emotional well-being primary outcome emotional problems measured with the Strengths and Difficulties Questionnaire SDQ in healthy adolescents between the ages of 14 to 18 years old during the COVID-19 pandemic
Our central hypothesis is that emotional well-being of adolescents in the intervention group will improve stronger or deteriorate less than in the control group We will test this hypothesis in 21 adolescents randomized to the TARA intervention partially delivered over Zoom 12 adolescents or to the waitlist control group 9 adolescents
Detailed Description:
None
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