Anxiety Clinical Trial
Official title:
Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT
Anxiety is a common mental health problem for Canadian youth. Anxiety that is diagnosed as a
disorder and serious enough to require treatment affects up to 10% of all youth by the age
of 16. 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
youth, parents and health care providers. Even if anxiety disorders are discovered, youth
may not get the right therapy. Anxious youth can become sick if their anxiety is not treated
properly.
The investigative team will carry out research to test Breathe, their new Internet-based
treatment for youth with anxiety problems. Youth can use this treatment at home. Breathe
includes information materials and personalized homework assignments to help anxious youth
learn ways to manage anxiety.
This study is a pilot 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 evaluate the change in youths' anxiety (primary outcome) from pre- to post-
intervention.
2. To estimate recruitment and retention rates for a full-scale RCT.
3. To estimate a sample size for a full-scale RCT.
4. To define the minimal clinically important difference (MCID) for the primary outcome
measure.
5. To measure intervention acceptability.
6. To determine the use of co-interventions during the trial.
7. To conduct a preliminary economic analysis.
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