Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-06 @ 5:30 AM
Study NCT ID:
NCT02970734
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating an Internet-based Program for Anxious Adolescents
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
Evaluating an Internet-based Program for Anxious Adolescents: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-09
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:
Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed as a disorder and serious enough to require treatment affects up to 10% of all adolescents by the age of 16. The median age of onset is 11 years, making these disorders some of the earliest to develop. Anxiety disorders can have serious negative effects on a young person's personal relationships, school performance, and family life. These disorders may not be discovered by adolescents, parents and health care providers. Even if anxiety disorders are discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if their anxiety is not treated properly. The investigators will carry out research to test Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can use this treatment from home via the computer. Breathe will include information materials and personalized homework assignments to help anxious adolescents learn ways to manage anxiety. More information can be found and www.TheBreatheStudy.com
Detailed Description:
This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage (control group; considered treatment as usual for youth waiting for services). The investigators will evaluate several methodological processes and outcomes through the following objectives:
1. To determine the effectiveness of a self-guided Internet-based CBT program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage.
2. To explore mediators and moderators of the Internet-based CBT program.
3. To determine the effectiveness of a self-guided Internet-based CBT program in improving quality of life as compared to a usual self-help intervention.
4. To determine adherence to a self-guided Internet-based CBT program.
5. To determine the cost-effectiveness of the Internet-based CBT program.
1. To determine the effectiveness of a self-guided Internet-based CBT program with limited telephone and email support in reducing anxiety symptoms among adolescents with mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based webpage.
2. To explore mediators and moderators of the Internet-based CBT program.
3. To determine the effectiveness of a self-guided Internet-based CBT program in improving quality of life as compared to a usual self-help intervention.
4. To determine adherence to a self-guided Internet-based CBT program.
5. To determine the cost-effectiveness of the Internet-based CBT program.
Study Oversight
Has Oversight DMC:
False
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?: