Optimizing Cognitive-behavioral Therapy for Social Anxiety Disorder Using the Factorial Design

NCT04879641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 464

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Social Anxiety Disorder (Social Phobia)

Interventions

BEHAVIORAL

Exposure

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.

BEHAVIORAL

Attention Training

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).

BEHAVIORAL

Cognitive Restructuring

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.

BEHAVIORAL

Psychoeducation

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.

Sponsors & Collaborators

  • University of Luebeck

    collaborator OTHER
  • University of Bern

    lead OTHER

Principal Investigators

  • Thomas T Berger, Prof. · University Bern, Clinical Psychology and Psychotherapy Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-15
Primary Completion
2023-10-18
Completion
2024-02-29

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879641 on ClinicalTrials.gov