Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial

Amanda S Newton, Lori Wozney, Alexa Bagnell, Eleanor Fitzpatrick, Sarah Curtis, Mona Jabbour, David Johnson, Rhonda J Rosychuk, Michael Young, Arto Ohinmaa, Anthony Joyce, Patrick McGrath, Amanda S Newton, Lori Wozney, Alexa Bagnell, Eleanor Fitzpatrick, Sarah Curtis, Mona Jabbour, David Johnson, Rhonda J Rosychuk, Michael Young, Arto Ohinmaa, Anthony Joyce, Patrick McGrath

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.

Trial registration: Clinicaltrials.gov NCT02059226; https://ichgcp.net/clinical-trials-registry/NCT02059226 (Archived by WebCite at http://www.webcitation.org/6epF8v7k4).

Keywords: Internet; adolescents; anxiety; cognitive behavioral therapy; etherapy; intervention; mental health; pilot; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: The IRIS platform used in this study was developed by co-author Patrick McGrath and is currently being redesigned for commercialization.

Figures

Figure 1
Figure 1
Trial flow diagram.
Figure 2
Figure 2
A screenshot of the Breathe program home screen.
Figure 3
Figure 3
A screenshot of a weekly self-assessment activity.
Figure 4
Figure 4
A screenshot of a learning activity.

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