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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathe | Experimental | 6 sessions of Internet-based cognitive behavioural therapy (CBT) with limited telephone and e-mail support |
|
| Resource webpage | Active Comparator | Webpage that provides general resources on anxiety |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathe | Behavioral | Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in adolescent anxiety using the total Multidimensional Anxiety Scale for Children (MASC 2) score | baseline to 6 weeks post-baseline (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in adolescent anxiety using the total MASC 2 score | 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) | baseline to 6 weeks post-baseline (post-intervention), 6 weeks post-baseline (post-intervention) to 18 weeks post-baseline (3-month follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Through study conduct, an average of 1 year. | |
| Retention rate | Through study conduct, an average of 1 year. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Newton | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Breathe Team | Edmonton | Alberta | T5N 3G8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36179438 | Derived | O'Connor KA, Bagnell A, Rosychuk RJ, Chen AA, Lingley-Pottie P, Radomski AD, Ohinmaa A, Joyce A, McGrath PJ, Newton AS. A randomized controlled trial evaluating the effect of an internet-based cognitive-behavioral program on anxiety symptoms in a community-based sample of adolescents. J Anxiety Disord. 2022 Dec;92:102637. doi: 10.1016/j.janxdis.2022.102637. Epub 2022 Sep 24. | |
| 32022692 |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Resource Webpage | Behavioral | Static webpage listing anxiety resources. |
|
| 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. | 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. | 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. | baseline, 18 weeks post-baseline |
| Derived |
| Radomski AD, Bagnell A, Curtis S, Hartling L, Newton AS. Examining the Usage, User Experience, and Perceived Impact of an Internet-Based Cognitive Behavioral Therapy Program for Adolescents With Anxiety: Randomized Controlled Trial. JMIR Ment Health. 2020 Feb 7;7(2):e15795. doi: 10.2196/15795. |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |