Computerized Treatment for Social Anxiety

NCT03101553 | Completed

• 1 other identifier: 2016.20077
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)

  change from baseline at one-week post treatment and 3-months post-treatment

• Beck Anxiety Inventory (BAI; Steer & Beck, 1997)

  change from baseline at one-week post treatment and 3-months post-treatment

• Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)

  change from baseline at one-week post treatment and 3-months post-treatment

Study Arms (2)

Interpretation Bias Modification

EXPERIMENTAL

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

Progressive Muscle Relaxation

ACTIVE COMPARATOR

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

Interventions

Interpretation Bias Modification BEHAVIORAL

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

Interpretation Bias Modification

Progressive Muscle Relaxation BEHAVIORAL

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

Progressive Muscle Relaxation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 5, 2017
• Study Start: February 10, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

US (1)