Clinical trial NCT02059226: Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT
Official title: Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: IWK Health Centre
First posted: 2014-02-11
Enrollment: 94
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in anxiety at 8 weeks
timeFrame: at 8 weeks (i.e., post-intervention)
Secondary outcomes:
measure: Recruitment rate
timeFrame: at 27 months
measure: Retention rate
timeFrame: at 30 months
measure: Minimal Clinically Important Difference (MCID)
timeFrame: at 8 weeks (i.e., post-intervention)
measure: Intervention acceptability
timeFrame: at 8 weeks (i.e., post-intervention)
measure: Co-intervention use
timeFrame: at 8 weeks (i.e., post-intervention)
measure: Resource use/costs
timeFrame: at 8 weeks
measure: Intervention adherence
timeFrame: at 8 weeks (i.e., post-intervention)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta; Alberta Health Services
state: Alberta
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario (CHEO)
state: Ontario
Study officials:
affiliation: University of Alberta
name: Amanda Newton
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor K, Bagnell A, McGrath P, Wozney L, Radomski A, Rosychuk RJ, Curtis S, Jabbour M, Fitzpatrick E, Johnson DW, Ohinmaa A, Joyce A, Newton A. An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial. JMIR Ment Health. 2020 Jul 24;7(7):e13356. doi: 10.2196/13356.
citation: Newton AS, Wozney L, Bagnell A, Fitzpatrick E, Curtis S, Jabbour M, Johnson D, Rosychuk RJ, Young M, Ohinmaa A, Joyce A, McGrath P. Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2016 Jan 29;5(1):e18. doi: 10.2196/resprot.4428.