Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder; Social Phobia
• Intervention / Treatment: Behavioral: Virtual Reality Exposure Therapy; Behavioral: Exposure in vivo

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1018 XA
    • University of Amsterdam, Department of Clinical Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
Experiences in Close Relationships Questionnaire		Pre-treatment
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)
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)
Simulator Sickness Questionnaire	This scale will be used in the Virtual Reality condition only	Session 2 (first week of treatment)
Credibility and Expectancy Questionnaire		Session 3 (second week of treatment)
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).
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.
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.

Collaborators and Investigators

• Sponsor: VU University of Amsterdam
• Investigators: Principal Investigator: Paul GM Emmelkamp, PhD, University of Amsterdam

Publications and helpful links

General Publications

• Kampmann IL, Emmelkamp PMG, Morina N. Cognitive predictors of treatment outcome for exposure therapy: do changes in self-efficacy, self-focused attention, and estimated social costs predict symptom improvement in social anxiety disorder? BMC Psychiatry. 2019 Feb 22;19(1):80. doi: 10.1186/s12888-019-2054-2.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: November 19, 2012
• First Submitted That Met QC Criteria: December 8, 2012
• First Posted (ESTIMATE): December 11, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Social Phobia; Virtual Reality; Social Anxiety Disorder; Exposure
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobia, Social; Phobic Disorders
• Other Study ID Numbers: 05510207