Computerized Treatment for Social Anxiety

Social Anxiety Disorder Clinical Trial

Official title:

Computerized Treatment for Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101553
• Other study ID #: 2016.20077
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: January 2021
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) The effects of condition will be maintained at the 3-month follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Current diagnosis of Social Anxiety Disorder according to DSM-5 criteria

• SPIN score greater than or equal to 30

• Must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation))

Exclusion Criteria:

• Concurrent psychotherapy or treatment for social anxiety disorder

• Clinically significant suicidality

• Current Alcohol Use Disorder of "Severe" severity or higher

• Current Non-alcohol Substance Use Disorder of "Moderate" severity or higher

• Recent changes (less than four weeks) in psychiatric medication

• History of psychotic symptoms

• May not have participated in a similar computerized treatment program

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Behavioral:
• Interpretation Bias Modification
Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.
• Progressive Muscle Relaxation
Eight 15-minute sessions of progressive muscle relaxation (PMR).

Locations

Country	Name	City	State
United States	Florida State University, Department of Psychology	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Phobia Inventory (SPIN; Davidson, 1995)	Measures past-week social anxiety symptom severity	change from baseline at one-week post treatment and 3-months post-treatment
Secondary	Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)	Measures depressive symptom severity	change from baseline at one-week post treatment and 3-months post-treatment
Secondary	Beck Anxiety Inventory (BAI; Steer & Beck, 1997)	Measure anxious symptom severity	change from baseline at one-week post treatment and 3-months post-treatment
Secondary	Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)	Measure of strength of evaluation related threat interpretation bias	change from baseline at one-week post treatment and 3-months post-treatment