Social Anxiety DisorderFOPSIINCT02379949
Virtual Reality Exposure Therapy for the Treatment of Social Phobia
A study testing Virtual Reality Exposure Therapy and Exposure Group Therapy in people with Social Anxiety Disorder, run by Georgia State University at 1 site in United States.
Trial summary
This randomized clinical trial compares virtual reality exposure therapy to exposure group therapy to a waiting list control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Virtual Reality Exposure Therapy and Exposure Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This randomized clinical trial compares virtual reality exposure therapy to exposure group therapy to a waiting list control group.
Read the 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Virtual Reality Exposure Therapy, Exposure Group Therapy
- Keywords
- virtual reality exposure therapy, social phobia, social anxiety disorder, cognitive behavioral therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure TherapyBehavioural
During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment.
Exposure Group TherapyBehavioural
Exposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months following final treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startAug 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Virtually Better, Inc.
- Responsible party
- Principal investigator, Page Anderson, Georgia State University
- Investigators
- Page L Anderson, Ph.D., Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379949
- Sponsor's protocol ID
- R42MH060506-02
- Acronym
- FOPSII
- Status last verified
- Feb 2015
- First submitted
- 29 Jan 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson PL, Zimand E, Hodges LF, Rothbaum BO. Cognitive behavioral therapy for public-speaking anxiety using virtual reality for exposure. Depress Anxiety. 2005;22(3):156-8. doi: 10.1002/da.20090.
PubMed 16231290Anderson, P., Rothbaum, B. O., & Hodges, L. F. Virtual reality exposure in the treatment of social anxiety. Cognitive and Behavioral Practice, 10: 240-247, 2003.
Andersson G, Carlbring P, Holmstrom A, Sparthan E, Furmark T, Nilsson-Ihrfelt E, Buhrman M, Ekselius L. Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. J Consult Clin Psychol. 2006 Aug;74(4):677-86. doi: 10.1037/0022-006X.74.4.677.
PubMed 16881775APA. Diagnostic and statistical manual of mental disorders, Fourth Edition - Text Revision (4th ed.): American Psychiatric Publishing, Inc. 2000.
Attkisson, C.C. & Greenfield, T.K.The UCSF client satisfaction scales: I. The Client Satisfaction Questionnaire-8. In M.E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (2nd ed., pp. 1333-1346). Mahwah, NJ: Erlbaum. 1999.
Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Manual for Beck Depression Inventory - II. San Antonio, TX: The Psychological Corporation, Harcourt, Brace & Company.
Beidel, D. C., Turner, S. M., Jacob, R. G., & Cooley, M. R. Assessment of social phobia: Reliability of an impromptu speech task. Journal of Anxiety Disorders, 3: 149-158, 1989.
Blote AW, Kint MJ, Miers AC, Westenberg PM. The relation between public speaking anxiety and social anxiety: a review. J Anxiety Disord. 2009 Apr;23(3):305-13. doi: 10.1016/j.janxdis.2008.11.007. Epub 2008 Nov 25.
PubMed 19117721Borkovec, T. D., & Nau, S. D. Credibility of analogue therapy rationales. Journal of Behavior Therapy and Experimental Psychiatry, 3: 257- 260, 1972.
Botella, C., Gallego, M. J., Garcia-Palacios, A., Baños, R. M., Quero, S., & Guillen, V. An internet-based self-help program for the treatment of fear of public speaking: A case study. Journal of Technology in Human Services, 26: 182-202, 2008.
Botella, C., García-Palacios, A., Villa, H., Baños, R. M., Quero, S., Alcañiz, M., & Riva, G. Virtual reality exposure in the treatment of panic disorder and agoraphobia: A controlled study. Clinical Psychology & Psychotherapy, 14: 164-175, 2007.
Bouchard, S., Dumoulin, S., Robillard, G., Guitard, T. & Klinger, E. et al. A randomized control trial for the use of in virtuo exposure in the treatment of social phobia: final results. Journal of CyberTherapy and Rehabilitation, 4: 197-199, 2011.
Bouton, M. E., Woods, A. M., Moody, E. W., Sunsay, C., & Garcia-Guitierrez, A. (2006). Counteracting the context-dependence of extinction: Relapse and some tests of possible methods of relapse prevention. In M. G. Craske, D. Hermans, & D. Vansteenwegen (Eds.), Fear and learning: Basic science to clinical application. (pp.175-196). Washington, DC: American Psychological Association.
Busseri MA, Tyler JD. Interchangeability of the Working Alliance Inventory and Working Alliance Inventory, Short Form. Psychol Assess. 2003 Jun;15(2):193-7. doi: 10.1037/1040-3590.15.2.193.
PubMed 12847779Collins KA, Westra HA, Dozois DJ, Stewart SH. The validity of the brief version of the Fear of Negative Evaluation Scale. J Anxiety Disord. 2005;19(3):345-59. doi: 10.1016/j.janxdis.2004.02.003.
PubMed 15686861
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy for the Treatment of Social Phobia
- ClinicalTrials.gov ID
- NCT02379949
- Acronym / sponsor ID
- FOPSII / R42MH060506-02
- Conditions
- Social Anxiety Disorder
- Keywords
- virtual reality exposure therapy, social phobia, social anxiety disorder, cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- Virtually Better, Inc.
- Study start
- Aug 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | Behavioral: Virtual Reality Exposure TherapyDuring virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment. |
| Exposure Group Therapy | Active comparator | Behavioral: Exposure Group TherapyExposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members. |
| Waitlist | No intervention | –Participants assigned to wait list were re-randomized to virtual reality exposure therapy or exposure group therapy following the waiting period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Exposure TherapyDuring virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment. | Behavioural | Virtual Reality Exposure Therapy |
| Exposure Group TherapyExposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members. | Behavioural | Exposure Group Therapy |
Primary outcome
Personal Report of Confidence as a Speaker
Time frame: Post-treatment, approximately 8 weeks after initial screening session
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Fear of Negative Evaluation-Brief Form
Time frame: Post-treatment, approximately 8 weeks after initial screening session
12-item questionnaire measuring the degree to which individuals fear being negatively evaluated by others across a number of social settings.
Behavioral Avoidance Test
Time frame: Post-treatment, approximately 8 weeks after initial screening session
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
Time frame: Post-treatment, approximately 8 weeks after initial screening session
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
Time frame: 3 months following final treatment session
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Fear of Negative Evaluation-Brief Form
Time frame: 3 months following final treatment session
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Behavioral Avoidance Test
Time frame: 3 months following final treatment session
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
Time frame: 3 months following final treatment session
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
Time frame: 12 months following final treatment session
30 true/false items measuring public speaking confidence across three dimensions: before, during, and after delivering a speech.
Fear of Negative Evaluation-Brief Form
Time frame: 12 months following final treatment session
12-item questionnaire measuring the degree to which individuals fear being negatively evaluated by others across a number of social settings.
Behavioral Avoidance Test
Time frame: 12 months following final treatment session
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
Time frame: 12 months following final treatment session
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- Background: PubMed 16231290Anderson PL, Zimand E, Hodges LF, Rothbaum BO. Cognitive behavioral therapy for public-speaking anxiety using virtual reality for exposure. Depress Anxiety. 2005;22(3):156-8. doi: 10.1002/da.20090.
- BackgroundAnderson, P., Rothbaum, B. O., & Hodges, L. F. Virtual reality exposure in the treatment of social anxiety. Cognitive and Behavioral Practice, 10: 240-247, 2003.
- Background: PubMed 16881775Andersson G, Carlbring P, Holmstrom A, Sparthan E, Furmark T, Nilsson-Ihrfelt E, Buhrman M, Ekselius L. Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial. J Consult Clin Psychol. 2006 Aug;74(4):677-86. doi: 10.1037/0022-006X.74.4.677.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Page L Anderson, Ph.D. principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exposure Therapy and Exposure Group Therapy in people with Social Anxiety Disorder, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Report of Confidence as a Speaker (time frame: Post-treatment, approximately 8 weeks after initial screening session). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02379949, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.