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Virtual Reality Exposure Therapy for the Treatment of Social Phobia (FOPSII)

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy
Exposure Group Therapy
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring virtual reality exposure therapy, social phobia, social anxiety disorder, cognitive behavioral therapy

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Georgia State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Virtual Reality Exposure Therapy

Exposure Group Therapy

Waitlist

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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
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).
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.
Fear of Negative Evaluation-Brief Form
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
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
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).
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2015
Last Updated
March 4, 2015
Sponsor
Georgia State University
Collaborators
Virtually Better, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02379949
Brief Title
Virtual Reality Exposure Therapy for the Treatment of Social Phobia
Acronym
FOPSII
Official Title
Virtual Reality Exposure Therapy for the Treatment of Social Phobia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Virtually Better, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized clinical trial compares virtual reality exposure therapy to exposure group therapy to a waiting list control group.
Detailed Description
Virtual reality exposure therapy (VRE) for the treatment of anxiety disorders has received considerable attention. During VRE, a person encounters a feared stimulus in a computer-generated environment, often through the use of a head mounted display and motion tracker that allows for multisensory input and natural movement. Several advantages of VRE have been noted - both clinical, such as treatment acceptability, and methodological, such as the ability to conduct exposure in a tightly controlled environment. Empirical support for VRE varies across anxiety disorders. Specifically, randomized controlled trials support the efficacy of VRE with fear of flying and acrophobia and show that it is equally effective as in vivo exposure. These phobias lend themselves well to VRE; the feared stimulus is circumscribed and contains powerful physical cues that can be produced within a virtual environment. There is less controlled research on the use of VRE for other anxiety disorders. The current study examines VRE for social anxiety disorder, which is characterized by fear of negative evaluation, and thus may be more difficult to evoke and treat using a virtual environment. Further, no research to date has compared VRE and the gold standard treatment for social anxiety disorder - cognitive behavioral therapy in a group format. The purpose of the current study is to compare VRE and Exposure Group Therapy to wait list in a sample of adults meeting criteria for social anxiety disorder with a primary fear of public speaking. It is hypothesized that, relative to wait list, those receiving treatment will improve on standardized measures of public speaking fears and fears of negative evaluation, as well as a behavioral avoidance task. Participants also are expected to maintain treatment gains at 3 and 12-month follow-up. Comparisons between the two active treatments also will be made. Procedure Following consent, study candidates completed a phone interview to screen for obvious exclusion criteria (e.g., current treatment for social anxiety disorder) and then an in-person, pretreatment assessment consisting of the Structured Clinical Interview for the DSM-IV (SCID), speech task, and the battery of self-report measures. Eligible participants were randomly assigned to virtual reality exposure therapy, exposure group therapy, or wait list by simple randomization using a computerized random number generator. Concealment procedures were used to prevent foreknowledge of treatment assignment from influencing enrollment. Each potential participant had a participant number, which was only known by the study coordinator. The first author kept a hard copy of a list linking participant number to condition assignment in a locked file drawer. Once a participant was enrolled, the study coordinator asked for the treatment condition for a particular participant number. The first author had no knowledge of which participant was linked with a participant number, and the study coordinator had no knowledge of which participant number was linked with treatment condition. Participants assigned to wait list were re-randomized to virtual reality exposure therapy or exposure group therapy following the waiting period (Figure 1). Participants completed all assessment and treatment sessions at a psychology clinic within at an urban research university that is accessible by public transportation. Assessments Participants completed assessments at pretreatment, posttreatment, and follow-up. Self-report outcome measures were completed at each assessment point. Participants were asked to complete the behavioral avoidance task at pretreatment and posttreatment. The anxiety, mood, and substance use modules of the SCID were administered at pretreatment, and the anxiety module was administered at the 3-month follow-up. All assessments were conducted by doctoral students who were blind to the type of treatment to be received. All pretreatment and follow-up diagnostic assessments were videotaped, and a randomly selected subset (N=10) were reviewed by a licensed psychologist to calculate the inter-rater reliability of pretreatment assessment (100% agreement for primary diagnosis, with one disagreement on severity). Compensation was provided to participants who completed the self-report battery of measures administered at posttreatment, 3- and 12-month follow-up. Treatment Prior to administering therapy, study therapists attended two day training workshops for each treatment, led by the developers of the respective treatments. Each study therapist also received weekly supervision by the first author. There were 5 study therapists: 2 licensed clinical psychologists with experience in manualized treatment, and 3 doctoral students with no experience with manualized treatments. All therapists administered both treatments. Both treatments were administered according to a manualized protocol for 8 sessions. The VRE and EGT treatment groups were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. Both treatments began with a treatment rationale and psychoeducation about social anxiety disorder. During sessions 2- 8, both treatments addressed specific aspects of social anxiety disorder identified in psychopathology literature, including self-focused attention, perceptions of self and others, perceptions of emotional control, rumination, realistic goal setting for social situations through the use of such techniques as cognitive preparation, and challenging of cost and probability biases. Session 8 also included relapse prevention. Homework was assigned for both treatments, including a daily mirror task, daily record of social situations, and identification of cognitive biases. Virtual Reality Exposure (VRE) Virtual environments included a virtual conference room (~5 audience members), a virtual classroom (~35 audience members), and a virtual auditorium (100+ audience members). Therapists could manipulate audience reactions in a number of ways including making them appear interested, bored, supportive, hostile, distracted (i.e., cell phone ringing). Virtual audience members could also pose questions, either standardized (e.g., "I don't understand, could you explain again") or tailored to the client using therapist voice-over. Virtual environments were manipulated according to the participants fear hierarchy. Participants were exposed to each item on their hierarchy until their fear decreased. Exposure Group Therapy (EGT) EGT was co-led by a licensed clinical psychologist and an advanced doctoral student. Groups consisted of up to five participants. During exposure, participants gave a videotaped speech in front of the group. Group members were also asked to provide each other with positive feedback when the videotaped speeches were reviewed. Every effort was made to equate time in exposure across treatment group. Participants receiving VRE completed 4 trials of exposure. Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials lasted no longer than 30 minutes, for a total of up to 120 minutes. Participants receiving EGT received 6 trials of exposure. The amount of time spent on each group member varied according to the number of participants in the group. On average, for a group with 4 participants, participants completed 6 trials of exposure for 20 minutes for a total of 120 minutes. Wait List After 8 weeks, wait list participants completed the self-report battery. Wait list participants were re-randomized to either virtual reality exposure or exposure group therapy following the waiting period and received the same 8-week treatment protocol described above.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
virtual reality exposure therapy, social phobia, social anxiety disorder, cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Exposure Therapy
Arm Type
Experimental
Arm Description
During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment.
Arm Title
Exposure Group Therapy
Arm Type
Active Comparator
Arm Description
Exposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Participants assigned to wait list were re-randomized to virtual reality exposure therapy or exposure group therapy following the waiting period.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment.
Intervention Type
Behavioral
Intervention Name(s)
Exposure Group Therapy
Intervention Description
Exposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members.
Primary Outcome Measure Information:
Title
Personal Report of Confidence as a Speaker
Description
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Time Frame
Post-treatment, approximately 8 weeks after initial screening session
Title
Fear of Negative Evaluation-Brief Form
Description
12-item questionnaire measuring the degree to which individuals fear being negatively evaluated by others across a number of social settings.
Time Frame
Post-treatment, approximately 8 weeks after initial screening session
Title
Behavioral Avoidance Test
Description
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
Time Frame
Post-treatment, approximately 8 weeks after initial screening session
Title
Clinician Global Impressions of Improvement
Description
A clinician-rated, global measure of change in severity of symptoms, ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
Post-treatment, approximately 8 weeks after initial screening session
Title
Personal Report of Confidence as a Speaker
Description
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Time Frame
3 months following final treatment session
Title
Fear of Negative Evaluation-Brief Form
Description
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Time Frame
3 months following final treatment session
Title
Behavioral Avoidance Test
Description
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
Time Frame
3 months following final treatment session
Title
Clinician Global Impressions of Improvement
Description
A clinician-rated, global measure of change in severity of symptoms, ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
3 months following final treatment session
Title
Personal Report of Confidence as a Speaker
Description
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Time Frame
12 months following final treatment session
Title
Fear of Negative Evaluation-Brief Form
Description
12-item questionnaire measuring the degree to which individuals fear being negatively evaluated by others across a number of social settings.
Time Frame
12 months following final treatment session
Title
Behavioral Avoidance Test
Description
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.
Time Frame
12 months following final treatment session
Title
Clinician Global Impressions of Improvement
Description
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.
Time Frame
12 months following final treatment session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Page L Anderson, Ph.D.
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30302
Country
United States

12. IPD Sharing Statement

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Virtual Reality Exposure Therapy for the Treatment of Social Phobia

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