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Evaluating an Internet-based Program for Anxious Youth: a Pilot RCT

NCT02059226 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-04-28

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

cognitive behavioural therapy

Internet-based CBT

OTHER

Internet-based resource page

Static webpage

Sponsors & Collaborators

  • IWK Health Centre

    collaborator OTHER

  • Mandi Newton

    lead OTHER

Principal Investigators

  • Amanda Newton · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059226 on ClinicalTrials.gov