Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

• Sponsor: VU University of Amsterdam (Other)
• Overall Status: Completed
• CT.gov ID: NCT01746667
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 3
• Duration (Months): 42
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual reality for social anxiety disorder. 70 patients with social anxiety disorder will be randomized to either one of the active conditions or to a waiting-list condition. Participants on the waiting-list will be offered either exposure in vivo of in virtual reality after a waiting period of five weeks. Levels of psychopathology will be assessed at pre- and post-treatment as well as three and 12 months after treatment.

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety Disorder; Social Phobia	Behavioral: Exposure in vivo; Behavioral: Virtual Reality Exposure Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exposure in vivo This treatment will consist of 10 sessions (twice a week) of exposure therapy based on the protocol used previously in exposure therapy for social anxiety disorder by Scholing & Emmelkamp (1993).	Behavioral: Exposure in vivo; Other Names: Behavior Therapy
Experimental: Virtual Reality Exposure Therapy This treatment consists of 10 sessions (twice a week) of exposure therapy by using virtual environments. The difference between the exposure in vivo and virtual reality exposure therapy is the exposure component, which will be delivered in vivo in one condition and through the Head Mounted Display (HMD) in the other condition.	Behavioral: Virtual Reality Exposure Therapy; Other Names: Virtual Reality Therapy
No Intervention: Wait-list Participants on the wait-list will be offered either exposure in vivo or in virtual reality after a waiting period of five weeks.

Outcome Measures

Primary Outcome Measures

1. Change from baseline: Liebowitz Social Anxiety Scale-Self report [Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.]

   Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

2. Change from baseline: Fear of Negative Evaluation Scale [Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.]

   Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

Secondary Outcome Measures

1. Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale [Pre-treatment to post-treatment (5 weeks)]

   The BAT consists of a videotaped 5 minute impromptu speech in front of two confederates. The Public Speaking Performance Scale will be used to evaluate the performance during the speech, both by patients and indipendent raters. Change from pre-treatment to post-treatment (5 weeks) will be examined.

2. Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module) [Pre-treatment to three months follow-up.]

   Change in diagnosis of Social Phobia from pre-treatment to three months follow-up.

3. Change from baseline: Depression Anxiety Stress Scale [Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.]

   Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

4. Change from baseline: Personality Disorder Belief Questionnaire [Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.]

   Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

5. Change from baseline: Eurohis Quality of Life Scale [Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.]

   Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

Other Outcome Measures

1. Change from baseline and in-treatment change: Focus of Attention Questionnaire [Pre-treatment to post-treatment (5 weeks), change during the course of four weeks of exposure therapy (session 3 until 9)]

   Focus of Attention will be assessed during the course of four weeks of exposure therapy that will take place twice a week (session 3 until 9). Change from pre-treatment to post-treatment (5 weeks) as well as change during treatment (four weeks) will be assessed.

2. In-treatment change: Social Phobia Weekly Summary Scale [Change from session to session during the course of five weeks (i.e., session 1 until 10)]

   The Social Phobia Weekly Summary Scale will be used in each session during the course of the treatment that will take place twice a week (session 1 until 10). Change during treatment will be assessed.

3. Change from baseline:Social Cost Questionnaire [Pre-treatment to session 7 (3,5 weeks) and post-treatment (5 weeks)]

   Change from pre-treatment to sessino 7 (3,5 weeks) and to post-treatment (5 weeks).

4. Experiences in Close Relationships Questionnaire [Pre-treatment]

5. In treatment change: Self-efficacy for Social Situations [Change from session to session during the course of five weeks (i.e., session 1 until 10)]

   Self-efficacy will be used in each session during the course the treatment that will take place twice a week (session 1 until 10). Change during treatment will be assessed (5 weeks).

6. In-treatment change: Working Alliance Inventory -Short Revised [Session 3 to session 6 (two weeks)]

   Change during treatment (with an expected average of two weeks) will be assessed.

7. Simulator Sickness Questionnaire [Session 2 (first week of treatment)]

   This scale will be used in the Virtual Reality condition only

8. Credibility and Expectancy Questionnaire [Session 3 (second week of treatment)]

9. In-treatment change: Ingroup Presence Questionnaire [Session 2 to session 3 (one week) and session and 6 (three weeks).]

   This scale will be used in the Virtual Reality condition only to measure change in the sense of presence from session 2 to session 3 (one week) and session 6 (three weeks).

10. Change from baseline: Dot-Probe Task [Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.]

    An implicit measure to assess attentional bias in social phobia. Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

11. Change from baseline: Approach Avoidance Task [Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.]

    A computer task to assess automatic approach and avoidance tendencies by measuring reaction times for pushing away or pulling closer faces with a joystick. Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 - 65 years old

• a primary diagnosis of social anxiety disorder as measured with the SCID

• fluency in Dutch.

Exclusion Criteria:

• psychotic episodes in the past, suicidal intentions or substance dependence.

• behavior therapy in the preceding one year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Amsterdam, Department of Clinical Psychology	Amsterdam		Netherlands	1018 XA

Sponsors and Collaborators

• VU University of Amsterdam

Investigators

• Principal Investigator: Paul GM Emmelkamp, PhD, University of Amsterdam
• Study Director: Nexhmedin Morina, PhD, University of Amsterdam

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paul M.G.Emmelkamp, Professor, VU University of Amsterdam
• ClinicalTrials.gov Identifier: NCT01746667
• Other Study ID Numbers: 05510207
• First Posted: Dec 11, 2012
• Last Update Posted: Mar 1, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Paul M.G.Emmelkamp, Professor, VU University of Amsterdam: Social Anxiety Disorder; Social Phobia; Virtual Reality; Exposure
• Additional relevant MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social

Study Results

No Results Posted as of Mar 1, 2017