title: Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial.
abstract: BACKGROUND
  There is a demand to make first-line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet-based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet-based CBT in children and adolescents and to determine related economic impacts.
  
  
  OBJECTIVE
  This pilot trial aims to collect the necessary data to inform the planning of a full-scale RCT to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically).
  
  
  METHODS
  We are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test the effectiveness of Internet-based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children); (2) determine a sample size for the full-scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co-interventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis in the full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school-based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet-based CBT with limited telephone and e-mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation sequence. Data are being collected at baseline, treatment completion, and at a 3-month follow-up.
  
  
  RESULTS
  Currently, adolescents are being enrolled in the study. Enrolment is taking place between March 2014 and February 2016; data collection will conclude May 2016. We expect that analysis and results will be available by August 2016.
  
  
  CONCLUSIONS
  In many communities, the resources available for front-line anxiety treatment are outweighed by the need for care. This pilot RCT is an essential step to designing a robust RCT to evaluate the effectiveness of an Internet-based CBT program for adolescents with moderate to mild anxiety problems.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226 (Archived by WebCite at http://www.webcitation.org/6epF8v7k4).
authors.affiliation: University of Alberta, Edmonton, AB, Canada. mandi.newton@ualberta.ca.
authors.forename: Amanda S
authors.identifier: http://orcid.org/0000-0003-3020-674X
authors.initials: AS
authors.lastname: Newton
authors.forename: Lori
authors.identifier: http://orcid.org/0000-0001-6933-9596
authors.initials: L
authors.lastname: Wozney
authors.forename: Alexa
authors.identifier: http://orcid.org/0000-0002-1484-9676
authors.initials: A
authors.lastname: Bagnell
authors.forename: Eleanor
authors.identifier: http://orcid.org/0000-0001-5223-8860
authors.initials: E
authors.lastname: Fitzpatrick
authors.forename: Sarah
authors.identifier: http://orcid.org/0000-0003-4996-7784
authors.initials: S
authors.lastname: Curtis
authors.forename: Mona
authors.identifier: http://orcid.org/0000-0002-0031-2026
authors.initials: M
authors.lastname: Jabbour
authors.forename: David
authors.identifier: http://orcid.org/0000-0001-8453-7849
authors.initials: D
authors.lastname: Johnson
authors.forename: Rhonda J
authors.identifier: http://orcid.org/0000-0001-8019-5466
authors.initials: RJ
authors.lastname: Rosychuk
authors.forename: Michael
authors.identifier: http://orcid.org/0000-0002-0256-3224
authors.initials: M
authors.lastname: Young
authors.forename: Arto
authors.identifier: http://orcid.org/0000-0002-7094-1573
authors.initials: A
authors.lastname: Ohinmaa
authors.forename: Anthony
authors.identifier: http://orcid.org/0000-0002-6728-2415
authors.initials: A
authors.lastname: Joyce
authors.forename: Patrick
authors.identifier: http://orcid.org/0000-0002-9568-2571
authors.initials: P
authors.lastname: McGrath
keywords: Internet; adolescents; anxiety; cognitive behavioral therapy; etherapy; intervention; mental health; pilot; randomized controlled trial
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