Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by VU University of Amsterdam
Sponsor:
Information provided by (Responsible Party):
Paul M.G.Emmelkamp, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT01746667
First received: November 19, 2012
Last updated: December 8, 2012
Last verified: December 2012
  Purpose

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 Intervention
Social Anxiety Disorder
Social Phobia
Behavioral: Exposure in vivo
Behavioral: Virtual Reality Exposure Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • Change from baseline: Liebowitz Social Anxiety Scale-Self report [ Time Frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up. ] [ Designated as safety issue: No ]
    Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.


Secondary Outcome Measures:
  • Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale [ Time Frame: Pre-treatment to post-treatment (5 weeks) ] [ Designated as safety issue: No ]

    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) [ Time Frame: Pre-treatment to three months follow-up. ] [ Designated as safety issue: No ]
    Change in diagnosis of Social Phobia from pre-treatment to three months follow-up.

  • Change from baseline: Depression Anxiety Stress Scale [ Time Frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up. ] [ Designated as safety issue: No ]
    Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.


Other Outcome Measures:
  • Change from baseline and in-treatment change: Focus of Attention Questionnaire [ Time Frame: Pre-treatment to post-treatment (5 weeks), change during the course of four weeks of exposure therapy (session 3 until 9) ] [ Designated as safety issue: No ]
    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.

  • In-treatment change: Social Phobia Weekly Summary Scale [ Time Frame: Change from session to session during the course of five weeks (i.e., session 1 until 10) ] [ Designated as safety issue: No ]
    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 baseline:Social Cost Questionnaire [ Time Frame: Pre-treatment to session 7 (3,5 weeks) and post-treatment (5 weeks) ] [ Designated as safety issue: No ]
    Change from pre-treatment to sessino 7 (3,5 weeks) and to post-treatment (5 weeks).

  • Experiences in Close Relationships Questionnaire [ Time Frame: Pre-treatment ] [ Designated as safety issue: No ]
  • In treatment change: Self-efficacy for Social Situations [ Time Frame: Change from session to session during the course of five weeks (i.e., session 1 until 10) ] [ Designated as safety issue: No ]
    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).

  • In-treatment change: Working Alliance Inventory -Short Revised [ Time Frame: Session 3 to session 6 (two weeks) ] [ Designated as safety issue: No ]
    Change during treatment (with an expected average of two weeks) will be assessed.

  • Simulator Sickness Questionnaire [ Time Frame: Session 2 (first week of treatment) ] [ Designated as safety issue: No ]
    This scale will be used in the Virtual Reality condition only

  • Credibility and Expectancy Questionnaire [ Time Frame: Session 3 (second week of treatment) ] [ Designated as safety issue: No ]
  • In-treatment change: Ingroup Presence Questionnaire [ Time Frame: Session 2 to session 3 (one week) and session and 6 (three weeks). ] [ Designated as safety issue: No ]
    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).

  • Change from baseline: Dot-Probe Task [ Time Frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up. ] [ Designated as safety issue: No ]
    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.

  • Change from baseline: Approach Avoidance Task [ Time Frame: Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746667

Contacts
Contact: Isabel L Kampmann, MSc 0031-205257084 I.L.Kampmann@uva.nl
Contact: Nexhmedin Morina, PhD 0031-2052580607 n.morina@uva.nl

Locations
Netherlands
University of Amsterdam, Department of Clinical Psychology Recruiting
Amsterdam, Netherlands, 1018 XA
Contact: Isabel L Kampmann, MSc    0031-205257084    I.L.Kampmann@uva.nl   
Contact: Nexhmedin Morina, PhD    0031-205257084    n.morina@uva.nl   
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Principal Investigator: Paul GM Emmelkamp, PhD VU University of Amsterdam
Study Director: Nexhmedin Morina, PhD VU University of Amsterdam
  More Information

No publications provided

Responsible Party: Paul M.G.Emmelkamp, Professor, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT01746667     History of Changes
Other Study ID Numbers: 05510207
Study First Received: November 19, 2012
Last Updated: December 8, 2012
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by VU University of Amsterdam:
Social Anxiety Disorder
Social Phobia
Virtual Reality
Exposure

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014