Dataset Information

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

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://clinicaltrials.gov/ct2/show/NCT04879641. Highlights • Internet-based cognitive-behavioral therapy (ICBT) allows us to disentangle treatment components of complex treatment packages.• Factorial trials are a suitable design to understand main and interaction effects of treatment components and the mechanisms of change.• Our program for social anxiety disorder consists of four components: psychoeducation, cognitive restructuring, attention training, and exposure.• We will test the effects for the four treatment components and the mediation of hypothesized mechanisms of change on outcomes.• Hypothesized mechanisms of change are knowledge gain of SAD, decrease of dysfunctional social cognitions, decrease of self-focused attention, decrease of avoidance and safety behaviors

SUBMITTER: Lopes R

PROVIDER: S-EPMC8605076 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background and aimsInternet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania).MethodsParticipants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures.ResultsA significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later.ConclusionsInternet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania.Trial registrationClinicalTrials.gov NCT01557894.