Anxiety
Conditions
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.
Interventions
BEHAVIORALBreathe
Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.
BEHAVIORALResource Webpage
Static webpage listing anxiety resources.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Score of ≥25 on the Screen for Child Anxiety Related Disorders (SCARED) * Ability to read and write English * Regular access to a telephone and a computer system with high speed Internet service * Ability to use the computer to interact with web material
Exclusion criteria
* Positive screen on the Ask Suicide-Screening Questionnaire (ASQ) * Positive screen on the Schizophrenia Test and Early Psychosis Indicator (STEPI; modified version) * Score of ≥3 on the Alcohol Use Disorders Identification Test Consumption subscale (AUDIT-C) * Residence outside of Canada
Design outcomes
Primary
| Measure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| User experience | 6 weeks post-baseline (post-intervention) | 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. |
| Intervention adherence | 6 weeks post-baseline (post-intervention) | 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. |
| health care utilization | baseline, 18 weeks post-baseline | 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. |
Other
| Measure | Time frame |
|---|---|
| Recruitment rate | Through study conduct, an average of 1 year. |
| Retention rate | Through study conduct, an average of 1 year. |
Countries
Canada
Outcome results
None listed