Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

Not Applicable

Completed

• Conditions: Social Anxiety Disorder; Social Phobia
• Interventions: Behavioral: Exposure in vivo; Behavioral: Virtual Reality Exposure Therapy

• Registration Number: NCT01746667
• Lead Sponsor: VU University of Amsterdam

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-12-08
• Study First Posted: 2012-12-11
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposure in vivo	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).
Virtual Reality Exposure Therapy	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

University of Amsterdam, Department of Clinical Psychology; 🇳🇱 Amsterdam, Netherlands