An interventional study of Breathe and Resource Webpage in Anxiety, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-02.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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
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:
University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support
Behavioral: Breathe
Webpage that provides general resources on anxiety
Behavioral: Resource Webpage
Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.
Static webpage listing anxiety resources.
Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score
Time frame: baseline to 6 weeks post-baseline (post-intervention)
Change in adolescent anxiety using the total MASC 2 score
Time frame: 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
Change in quality of life using the Youth Quality of Life Instrument - Short Form (YQOL-SF)
Time frame: baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up)
User experience
Developed by the investigators, this electronically administered, self-report instrument will assess participant satisfaction (e.g., ease of use, layout, convenience) perceived credibility and impact (e.g., helpfulness, knowledge gains, confidence in the program/website), and adherence and usage (e.g., barriers and facilitators to treatment) with an Internet-based program/webpage.
Time frame: 6 weeks post-baseline (post-intervention)
Intervention adherence
Intervention adherence will be measured by documenting the number of sessions and homework tasks completed. The investigators will also record the number of tailored sessions completed by each participant (intervention condition) and site visits (control condition). These data will be collected through the intervention's software system.
Time frame: 6 weeks post-baseline (post-intervention)
health care utilization
Developed by the investigators, this self-report instrument will assess whether participants have accessed health care resources (i.e., met with a psychologist/psychiatrist/family doctor/hospital etc.) and if so, how many times.
Time frame: baseline, 18 weeks post-baseline
Recruitment rate
Time frame: Through study conduct, an average of 1 year.
Retention rate
Time frame: Through study conduct, an average of 1 year.
Plan to share: No
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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University of Alberta