NCT02379949

Brief Summary

This randomized clinical trial compares virtual reality exposure therapy to exposure group therapy to a waiting list control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
Last Updated

March 5, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

January 29, 2015

Last Update Submit

March 4, 2015

Conditions

Social Anxiety Disorder

Keywords

virtual reality exposure therapysocial phobiasocial anxiety disordercognitive behavioral therapy

Outcome Measures

Primary Outcomes (12)

  • Personal Report of Confidence as a Speaker

    30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.

    Post-treatment, approximately 8 weeks after initial screening session

  • Fear of Negative Evaluation-Brief Form

    12-item questionnaire measuring the degree to which individuals fear being negatively evaluated by others across a number of social settings.

    Post-treatment, approximately 8 weeks after initial screening session

  • Behavioral Avoidance Test

    The behavioral avoidance test was based on a standardized speech assessment protocol (Beidel, Turner, Jacob, \& Cooley, 1989), in which participants are given 3 min to prepare notes on five controversial topics (e.g., abortion, same-sex marriage). Participants are then asked to speak for 10 min on up to three topics and to rate how well they performed (0 -10) and how anxious they felt (0 -10), with higher numbers indicating better performance and higher anxiety. Audience members consisted of two to four trained undergraduate or graduate students; the therapist was never an audience member

    Post-treatment, approximately 8 weeks after initial screening session

  • Clinician Global Impressions of Improvement

    A clinician-rated, global measure of change in severity of symptoms, ranging from 1 (very much improved) to 7 (very much worse).

    Post-treatment, approximately 8 weeks after initial screening session

  • Personal Report of Confidence as a Speaker

    30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.

    3 months following final treatment session

  • Fear of Negative Evaluation-Brief Form

    30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.

    3 months following final treatment session

  • Behavioral Avoidance Test

    The behavioral avoidance test was based on a standardized speech assessment protocol (Beidel, Turner, Jacob, \& Cooley, 1989), in which participants are given 3 min to prepare notes on five controversial topics (e.g., abortion, same-sex marriage). Participants are then asked to speak for 10 min on up to three topics and to rate how well they performed (0 -10) and how anxious they felt (0 -10), with higher numbers indicating better performance and higher anxiety. Audience members consisted of two to four trained undergraduate or graduate students; the therapist was never an audience member

    3 months following final treatment session

  • Clinician Global Impressions of Improvement

    A clinician-rated, global measure of change in severity of symptoms, ranging from 1 (very much improved) to 7 (very much worse).

    3 months following final treatment session

  • Personal Report of Confidence as a Speaker

    30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.

    12 months following final treatment session

  • Fear of Negative Evaluation-Brief Form

    12-item questionnaire measuring the degree to which individuals fear being negatively evaluated by others across a number of social settings.

    12 months following final treatment session

  • Behavioral Avoidance Test

    The behavioral avoidance test was based on a standardized speech assessment protocol (Beidel, Turner, Jacob, \& Cooley, 1989), in which participants are given 3 min to prepare notes on five controversial topics (e.g., abortion, same-sex marriage). Participants are then asked to speak for 10 min on up to three topics and to rate how well they performed (0 -10) and how anxious they felt (0 -10), with higher numbers indicating better performance and higher anxiety. Audience members consisted of two to four trained undergraduate or graduate students; the therapist was never an audience member.

    12 months following final treatment session

  • Clinician Global Impressions of Improvement

    The behavioral avoidance test was based on a standardized speech assessment protocol (Beidel, Turner, Jacob, \& Cooley, 1989), in which participants are given 3 min to prepare notes on five controversial topics (e.g., abortion, same-sex marriage). Participants are then asked to speak for 10 min on up to three topics and to rate how well they performed (0 -10) and how anxious they felt (0 -10), with higher numbers indicating better performance and higher anxiety. Audience members consisted of two to four trained undergraduate or graduate students; the therapist was never an audience member.

    12 months following final treatment session

Study Arms (3)

Virtual Reality Exposure Therapy

EXPERIMENTAL

During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment.

Behavioral: Virtual Reality Exposure Therapy

Exposure Group Therapy

ACTIVE COMPARATOR

Exposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members.

Behavioral: Exposure Group Therapy

Waitlist

NO INTERVENTION

Participants assigned to wait list were re-randomized to virtual reality exposure therapy or exposure group therapy following the waiting period.

Interventions

Virtual Reality Exposure TherapyBEHAVIORAL

During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment.

Virtual Reality Exposure Therapy
Exposure Group TherapyBEHAVIORAL

Exposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members.

Exposure Group Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Speakers of English meeting DSM-IV (APA, 2000) criteria for a primary diagnosis of social anxiety disorder
  • Self-identifying public speaking as their primary social fear
  • Participants were required to be stabilized on psychoactive medication(s) and dosage(s) for 3 months.

You may not qualify if:

  • history of mania, schizophrenia, or psychosis
  • current suicidal ideation, alcohol, or substance dependence
  • inability to tolerate the virtual reality helmet/environment
  • history of seizures
  • concurrent psychotherapy for social anxiety disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30302, United States

Location

Related Publications (53)

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MeSH Terms

Conditions

Phobia, Social

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Page L Anderson, Ph.D.

    Georgia State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2015

First Posted

March 5, 2015

Study Start

August 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

March 5, 2015

Record last verified: 2015-02

Locations

US(1)