Optimizing cognitive-behavioral therapy for social anxiety disorder and understanding the mechanisms of change: Study protocol for a randomized factorial trial

Rodrigo C T Lopes, Dajana Šipka, Tobias Krieger, Jan Philipp Klein, Thomas Berger, Rodrigo C T Lopes, Dajana Šipka, Tobias Krieger, Jan Philipp Klein, Thomas Berger

Abstract

Background: Social anxiety disorder (SAD) is characterized by a marked fear of negative evaluation in social situations and significant impairments. Even with the most effective treatments, remission rates are around 50%. An important reason for the limited effectiveness of treatments is the lack of evidence-based explanation of how treatments work and what their active ingredients might be. An approach to unpack the active ingredients and mechanisms of treatment is the factorial design.

Objectives: The study is a factorial trial aiming (1) to examine the main effects and interactions for the four main treatment components of internet-based cognitive-behavioral therapy (ICBT) for SAD (i.e., psychoeducation, cognitive restructuring, attentional training, and exposure) and (2) to examine whether and which change mechanisms mediate the relationship between treatment components and symptom reduction.

Methods: A total of 464 adults diagnosed with SAD will be randomized to one of 16 conditions containing combinations of the treatment components. The primary endpoint is SAD symptomatology at eight weeks. Secondary endpoints include symptoms of depression and anxiety, quality of life, and negative effects. Hypothesized change mechanisms are the increase of knowledge about SAD, the decrease of dysfunctional cognitions, the decrease of self-focused attention, and the decrease of avoidance and safety behaviors.

Discussion: A better understanding of the differential efficacy of treatment components and mechanisms of treatment underlying ICBT for SAD might inform clinicians and researchers to plan more potent and scalable treatments.

Trial registration: clinicaltrials.gov (NCT04879641) on June, 11th 2021. https://ichgcp.net/clinical-trials-registry/NCT04879641.

Keywords: Factorial design; Internet-based cognitive-behavioral therapy; Mechanisms of change; Social anxiety.

Conflict of interest statement

All the authors have no financial or scientific competing interests to declare.

© 2021 University of Bern.

Figures

Fig. 1
Fig. 1
Design of the study and expected participants' flow.
Fig. 2
Fig. 2
Simplified conceptual model of the effects of the four treatment components on the hypothesized change mechanisms and primary and secondary outcomes.

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