Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

Social Anxiety Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746667
• Other study ID #: 05510207
• Status: Completed
• Phase: N/A
• First received: November 19, 2012
• Last updated: February 28, 2017
• Start date: February 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2017
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder
• Social Phobia

Intervention

Behavioral:
• Exposure in vivo

• Virtual Reality Exposure Therapy

Locations

Country	Name	City	State
Netherlands	University of Amsterdam, Department of Clinical Psychology	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline and in-treatment change: Focus of Attention Questionnaire	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.	Pre-treatment to post-treatment (5 weeks), change during the course of four weeks of exposure therapy (session 3 until 9)
Other	In-treatment change: Social Phobia Weekly Summary Scale	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.	Change from session to session during the course of five weeks (i.e., session 1 until 10)
Other	Change from baseline:Social Cost Questionnaire	Change from pre-treatment to sessino 7 (3,5 weeks) and to post-treatment (5 weeks).	Pre-treatment to session 7 (3,5 weeks) and post-treatment (5 weeks)
Other	Experiences in Close Relationships Questionnaire		Pre-treatment
Other	In treatment change: Self-efficacy for Social Situations	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).	Change from session to session during the course of five weeks (i.e., session 1 until 10)
Other	In-treatment change: Working Alliance Inventory -Short Revised	Change during treatment (with an expected average of two weeks) will be assessed.	Session 3 to session 6 (two weeks)
Other	Simulator Sickness Questionnaire	This scale will be used in the Virtual Reality condition only	Session 2 (first week of treatment)
Other	Credibility and Expectancy Questionnaire		Session 3 (second week of treatment)
Other	In-treatment change: Ingroup Presence Questionnaire	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).	Session 2 to session 3 (one week) and session and 6 (three weeks).
Other	Change from baseline: Dot-Probe Task	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.	Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Other	Change from baseline: Approach Avoidance Task	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.	Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Primary	Change from baseline: Liebowitz Social Anxiety Scale-Self report	Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.	Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Primary	Change from baseline: Fear of Negative Evaluation Scale	Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.	Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Secondary	Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale	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.	Pre-treatment to post-treatment (5 weeks)
Secondary	Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module)	Change in diagnosis of Social Phobia from pre-treatment to three months follow-up.	Pre-treatment to three months follow-up.
Secondary	Change from baseline: Depression Anxiety Stress Scale	Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.	Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Secondary	Change from baseline: Personality Disorder Belief Questionnaire	Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.	Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Secondary	Change from baseline: Eurohis Quality of Life Scale	Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.	Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.