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Computerized Treatment for Social Anxiety

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpretation Bias Modification
Progressive Muscle Relaxation
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida State University, Department of Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interpretation Bias Modification

Progressive Muscle Relaxation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Social Phobia Inventory (SPIN; Davidson, 1995)
Measures past-week social anxiety symptom severity

Secondary Outcome Measures

Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Measures depressive symptom severity
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Measure anxious symptom severity
Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)
Measure of strength of evaluation related threat interpretation bias

Full Information

First Posted
March 30, 2017
Last Updated
January 26, 2021
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT03101553
Brief Title
Computerized Treatment for Social Anxiety
Official Title
Computerized Treatment for Social Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interpretation Bias Modification
Arm Type
Experimental
Arm Description
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.
Arm Title
Progressive Muscle Relaxation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpretation Bias Modification
Intervention Description
Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
Eight 15-minute sessions of progressive muscle relaxation (PMR).
Primary Outcome Measure Information:
Title
Social Phobia Inventory (SPIN; Davidson, 1995)
Description
Measures past-week social anxiety symptom severity
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Description
Measures depressive symptom severity
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment
Title
Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
Description
Measure anxious symptom severity
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment
Title
Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)
Description
Measure of strength of evaluation related threat interpretation bias
Time Frame
change from baseline at one-week post treatment and 3-months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Florida State University, Department of Psychology
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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Computerized Treatment for Social Anxiety

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