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

This pilot trial aims to collect the necessary data to inform the planning of a full-scale randomized controlled trial (RCT) to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). Adolescents will be randomly assigned to either 8 weeks of Internet-based cognitive behaviour therapy (CBT) with telephone and e-mail support (the Breathe program), or a control (minimal intervention) group with 8 weeks of access to a static webpage with general anxiety resources and information. The pilot RCT will (1) define a minimal clinically important difference, as defined by adolescents, for the primary outcome measure, (2) determine a sample size for a full-scale RCT, (3) estimate recruitment and retention rates to determine the number of study sites needed, (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 for a full-scale RCT.