Computerized Treatment for Social Anxiety

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Progressive Muscle Relaxation; Behavioral: Interpretation Bias Modification

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University, Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interpretation Bias Modification; Treatment consists of eight brief sessions consisting of two tasks. In Task 1, participants read unique scenarios ("You notice someone pointing in your direction"). A sentence meant to resolve the ambiguity will appear ("This person thinks they reco_nize you"). After filling in the missing letter, the interpretation is reinforced by requiring the participants to correctly answer "yes" or "no" to a comprehension question ("Is this person mocking you?"). In Task 2, participants are shown a word denoting a threatening ("mocking") or benign ("cheerful") interpretation. Participants are presented with an ambiguous scenario ("You hear people at a nearby table laughing") and asked to denote whether the word and the sentence are related. Participants will receive feedback based on their response.	Behavioral: Interpretation Bias Modification; Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.
Active Comparator: Progressive Muscle Relaxation; Participants will receive eight brief sessions of PMR. They will listen to a PMR script (Kassinove & Tafrate, 2002). Participants will be asked to make sure they are sitting comfortably, close their eyes, and systematically tense and release different muscle groups.	Behavioral: Progressive Muscle Relaxation; Eight 15-minute sessions of progressive muscle relaxation (PMR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)	Measure anxious symptom severity	change from baseline at one-week post treatment and 3-months post-treatment
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

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: 2016.20077

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No