CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 464 enrolled
Drug / intervention
Exposure +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04879641
NCT04879641N/ACompleted

Optimizing Cognitive-behavioral Therapy for Social Anxiety Disorder Using the Factorial Design: What Works Best and How Does it Work (OPTIMIZE)

University of Bern·interventional·Posted May 10, 2021·Updated May 16, 2024

In Brief

A clinical study evaluating Exposure, Attention Training, and 2 other interventions for Social Anxiety Disorder (Social Phobia). Completed, enrolled 464 participants across 1 site.

Detailed Summary

Social Anxiety Disorder (SAD) is characterized by a marked fear of negative evaluation in social situations. It is the third most common psychiatric disorder and highly disabling (American Psychiatric Association, 2000). Although effective treatments such as cognitive-behavioral therapy (CBT) are available, most individuals suffering from SAD do not seek and eventually find help, and even in the best available treatments, remission rates are below 50%. The overall aim of the project is to better understand and improve the efficacy of Internet-based CBT (ICBT) that has shown to be efficacious in many trials and that provide broad and low-threshold access to empirically supported treatments. Specifically the objectives of the study are: 1. to investigate the active ingredients of ICBT for SAD by testing the main effects and interactions for the four main treatment components (i.e., psychoeducation, cognitive restructuring, attention training, and exposure); 2. to investigate the effects of each treatment component on hypothesized change mechanisms, and to explore whether and which change mechanisms mediate the effect of the treatment components on symptom reduction. 3. to investigate whether the specific mechanisms mediate the effect of the treatment components on primary and secondary outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 10, 2021
Enrollment StartAug 15, 2021
Primary CompletionOct 18, 2023
Study CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.1 years ago

Interventions

Exposurebehavioral

Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.

Attention Trainingbehavioral

Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).

Cognitive Restructuringbehavioral

Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.

Psychoeducationbehavioral

Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.