Computerized Treatment for Social Anxiety

NCT ID: NCT03101553

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-10
• Study Completion Date: 2017-11-01

Brief 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.

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Interpretation Bias Modification

Intervention Type: BEHAVIORAL

Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.

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.

Group Type: ACTIVE_COMPARATOR

Progressive Muscle Relaxation

Intervention Type: BEHAVIORAL

Eight 15-minute sessions of progressive muscle relaxation (PMR).

Interventions

Interpretation Bias Modification

Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.

Intervention Type: BEHAVIORAL

Progressive Muscle Relaxation

Eight 15-minute sessions of progressive muscle relaxation (PMR).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Jesse Cougle

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florida State University, Department of Psychology

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

2016.20077

Identifier Type: -

Identifier Source: org_study_id