A Multisite Non-Inferiority Randomized Controlled Trial of the Efficacy of Cognitive-Behavior Therapy for Generalized...

Delivering psychotherapy by videoconference has been studied in a number of clinical trials, but no large controlled trial has involved generalized anxiety disorder (GAD). This multicenter randomized controlled non-inferiority trial was conducted to test if cognitive-behavior psychotherapy delivered by videoconference (VCP) is as effective as cognitive-behavior psychotherapy delivered face-to-face, using a strict margin of tolerance for non-inferiority. A total of 148 adults received a 15-session weekly manualized program. The treatment was based on the intolerance of uncertainty model of GAD. The impact of treatment was assessed using primary (GAD severity), secondary (worry, anxiety, and intolerance of uncertainty) and tertiary (general functioning) variables measured before and after treatment and at 6-month and 12-month follow-ups. Results showed that: (a) the treatment was effective; (b) VCP for GAD was statistically non-inferior to face-to-face psychotherapy on primary, secondary and tertiary measures at all assessment points; (c) change in intolerance of uncertainty significantly predicted change in the primary outcome measure over and above important clinical factors common to all psychotherapies (motivation, working alliance, perceived therapist competence, and client satisfaction). These findings support the use of VCP as a promising treatment option for adults with GAD. Clinical trial registry: ISRCTN#12662027.