Overview

This trial is active, not recruiting.

Condition anxiety
Treatments cognitive behavioural therapy, internet-based resource page
Sponsor Mandi Newton
Collaborator IWK Health Centre
Start date April 2014
End date October 2016
Trial size 80 participants
Trial identifier NCT02059226, CIHR (MOP119531), Pro00036087

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Internet-based cognitive behavioural therapy
cognitive behavioural therapy
Internet-based CBT
(Active Comparator)
Static webpage
internet-based resource page
Static webpage

Primary Outcomes

Measure
Change from baseline in anxiety at 8 weeks
time frame: at 8 weeks (i.e., post-intervention)

Secondary Outcomes

Measure
Recruitment rate
time frame: at 27 months
Retention rate
time frame: at 30 months
Minimal Clinically Important Difference (MCID)
time frame: at 8 weeks (i.e., post-intervention)
Intervention acceptability
time frame: at 8 weeks (i.e., post-intervention)
Co-intervention use
time frame: at 8 weeks (i.e., post-intervention)
Resource use/costs
time frame: at 8 weeks
Intervention adherence
time frame: at 8 weeks (i.e., post-intervention)

Eligibility Criteria

Male or female participants from 13 years up to 17 years old.

Inclusion Criteria: - DSM-IV social anxiety, generalized anxiety, anxiety not otherwise specified, or adjustment disorder as the primary clinical problem - ability to read and write English - regular access to a telephone and a computer system with high speed Internet service - ability to use a computer to interact with web material - youth aged 13-14 must have a consenting parent Exclusion Criteria: - youth with an anxiety problem that is not included above - youth who receive cognitive behavioural therapy - youth who cannot provide consent

Additional Information

Official title Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT
Principal investigator Amanda Newton
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Alberta.