Safety and efficacy of a modular digital psychotherapy for social anxiety: A randomized controlled trial

Abstract

BackgroundSocial anxiety disorder is a common mental health condition characterized by an intense fear of social situations which can lead to significant impairment in daily life. Cognitive behavioral therapy (CBT) has been recognized as an effective treatment; however, access to therapists is limited and the fear of interacting with therapists can delay treatment seeking. Furthermore, not all individuals respond. Tailoring modular treatments to individual cognitive profiles may improve efficacy. We developed a novel digital adaptation of CBT for social anxiety that is both modular and fully digital without therapist in the loop and implemented it in a smartphone app.ObjectiveTo evaluate the safety, acceptability and efficacy of the new treatment in online participants with symptoms of social anxietyMethodsTwo online randomized controlled trials comparing individuals with access to the treatment through the app to waitlist. Participants were recruited online and reported Social Phobia Inventory (SPIN) total scores >= 30. Primary outcomes were safety and efficacy over 6 weeks in 102 women aged 18-35 (RCT #1) and symptom reduction (Social Phobia Inventory total scores) after 8 weeks in 267 men and women aged 18-75 (RCT #2).ResultsIn RCT #1, active and control arm adverse event frequency and severity was not distinguishable. App acceptability was high. Secondary outcomes suggested greater symptom reduction in the active (-9.83 ± 12.80) than the control arm (-4.13 ± 11.59, t90= -2.23, pFDR= .037, Cohen’s d = 0.47). In RCT #2, there was a higher symptom reduction in the active arm (-12.89 ± 13.87) than the control arm (-7.48 ± 12.24, t227= - 3.13, pFDR= .008, Cohen’s d = 0.42).ConclusionsThe online-only, modular social anxiety CBT program appears safe, acceptable and efficacious in an online patient group with self-reported symptoms of social anxiety.Trial RegistrationRCT #1: ClinicalTrials.govNCT05858294, RCT #2: ClinicalTrials.govNCT05987969