Integrating Videoconferencing Therapist Guidance Into Stepped-Care ICBT for Childhood and Adolescent Anxiety: Non-Inferiority Randomised Controlled Trial (Preprint)

BACKGROUND Internet-delivered cognitive behaviour therapy (ICBT) delivered with therapist-guidance has demonstrated efficacy for the treatment of child and adolescent anxiety, though widespread delivery is limited by therapist availability. Self-guided ICBT achieves greater reach, though demonstrates poorer engagement and less clinical benefits. Alternative models of care are required that promote engagement, are effective, accessible, and scalable. OBJECTIVE This preregistered randomised trial evaluated whether a stepped-care approach to ICBT using therapist guidance via videoconferencing for the step-up component (ICBT-SC(VC)) is non-inferior to therapist-guided ICBT (ICBT-TG(VC)) for child and adolescent anxiety. METHODS Participants included 137 Australian children and adolescents aged 7-17 years (61 male), with a primary anxiety disorder. This randomised, non-inferiority trial compared ICBT-SC(VC) to an ICBT-TG(VC) program with assessments conducted at baseline, 12-weeks, and 9-months after treatment commencement. All ICBT-TG(VC) participants received therapist guidance (videoconferencing) after each session, for all 10 sessions. All ICBT-SC(VC) participants completed the first 5 sessions online without therapist guidance. If they demonstrated response to treatment after the first 5 sessions (defined as reductions in anxiety symptoms into the non-clinical range), they continued the online sessions in a self-guided manner (no therapist guidance). If they did not respond, participants were stepped-up to receive supplemental therapist-guidance (videoconferencing) for the remaining sessions. Measures included clinical diagnostic interview with clinician-rated severity rating as the primary outcome, as well as parent and child reported anxiety and anxiety-related interference (secondary outcomes). RESULTS Though there were no significant differences between treatment conditions on primary and almost all secondary outcome measures, tests of non-inferiority did not confirm non-inferiority of ICBT-SC(VC) compared to ICBT-TG(VC). Significant clinical benefits were evident for participants in both treatments, though this was significantly higher for ICBT-TG(VC) participants. Of participants who remained in the study, 68% (41% ITT) of ICBT-SC(VC) and 88% (69% ITT) of ICBT-TG(VC) were free of their primary anxiety diagnosis by 9-month follow-up. Therapy compliance was lower for ICBT-SC(VC) than ICBT-TG(VC), though treatment satisfaction was moderate to high in both conditions. CONCLUSIONS This study provided further support for the benefits of low-intensity stepped-care adaptive approaches to ICBT for anxious children and adolescents and highlighted the excellent treatment outcomes that can be achieved through therapist-guided ICBT delivered via videoconferencing. Both treatments may offer an acceptable treatment model that could increase access to evidence-based care. CLINICALTRIAL The study’s design, hypotheses and analysis plan were preregistered with the Australian and New Zealand Clinical Trials Registry (ACTRN12618001418268).