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Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

Primary Purpose

Social Anxiety Disorder, Social Phobia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Exposure in vivo
Virtual Reality Exposure Therapy
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety Disorder, Social Phobia, Virtual Reality, Exposure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Amsterdam, Department of Clinical Psychology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Exposure in vivo

Virtual Reality Exposure Therapy

Wait-list

Arm Description

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).

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.

Participants on the wait-list will be offered either exposure in vivo or in virtual reality after a waiting period of five weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 19, 2012
Last Updated
February 28, 2017
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT01746667
Brief Title
Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder, Social Phobia
Keywords
Social Anxiety Disorder, Social Phobia, Virtual Reality, Exposure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure in vivo
Arm Type
Experimental
Arm Description
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).
Arm Title
Virtual Reality Exposure Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
Participants on the wait-list will be offered either exposure in vivo or in virtual reality after a waiting period of five weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exposure in vivo
Other Intervention Name(s)
Behavior Therapy
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy
Other Intervention Name(s)
Virtual Reality Therapy
Primary Outcome Measure Information:
Title
Change from baseline: Liebowitz Social Anxiety Scale-Self report
Description
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Time Frame
Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Title
Change from baseline: Fear of Negative Evaluation Scale
Description
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Time Frame
Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Secondary Outcome Measure Information:
Title
Change from baseline: Behavioral Assessment Task (BAT), Public Speaking Performance Scale
Description
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.
Time Frame
Pre-treatment to post-treatment (5 weeks)
Title
Change from baseline: Structured Clinical Interview for DSM-IV (Social Phobia Module)
Description
Change in diagnosis of Social Phobia from pre-treatment to three months follow-up.
Time Frame
Pre-treatment to three months follow-up.
Title
Change from baseline: Depression Anxiety Stress Scale
Description
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Time Frame
Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Title
Change from baseline: Personality Disorder Belief Questionnaire
Description
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Time Frame
Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Title
Change from baseline: Eurohis Quality of Life Scale
Description
Change from pre-treatment to post-treatment (5 weeks), 3 months follow-up and 12 months follow-up.
Time Frame
Pre-treatment to post-treatment (5 weeks), three months follow-up, 12 months follow-up.
Other Pre-specified Outcome Measures:
Title
Change from baseline and in-treatment change: Focus of Attention Questionnaire
Description
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.
Time Frame
Pre-treatment to post-treatment (5 weeks), change during the course of four weeks of exposure therapy (session 3 until 9)
Title
In-treatment change: Social Phobia Weekly Summary Scale
Description
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.
Time Frame
Change from session to session during the course of five weeks (i.e., session 1 until 10)
Title
Change from baseline:Social Cost Questionnaire
Description
Change from pre-treatment to sessino 7 (3,5 weeks) and to post-treatment (5 weeks).
Time Frame
Pre-treatment to session 7 (3,5 weeks) and post-treatment (5 weeks)
Title
Experiences in Close Relationships Questionnaire
Time Frame
Pre-treatment
Title
In treatment change: Self-efficacy for Social Situations
Description
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).
Time Frame
Change from session to session during the course of five weeks (i.e., session 1 until 10)
Title
In-treatment change: Working Alliance Inventory -Short Revised
Description
Change during treatment (with an expected average of two weeks) will be assessed.
Time Frame
Session 3 to session 6 (two weeks)
Title
Simulator Sickness Questionnaire
Description
This scale will be used in the Virtual Reality condition only
Time Frame
Session 2 (first week of treatment)
Title
Credibility and Expectancy Questionnaire
Time Frame
Session 3 (second week of treatment)
Title
In-treatment change: Ingroup Presence Questionnaire
Description
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).
Time Frame
Session 2 to session 3 (one week) and session and 6 (three weeks).
Title
Change from baseline: Dot-Probe Task
Description
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.
Time Frame
Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.
Title
Change from baseline: Approach Avoidance Task
Description
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.
Time Frame
Pre-treatment to post-treatment (5 weeks), three months follow-up, and 12 months follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul GM Emmelkamp, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nexhmedin Morina, PhD
Organizational Affiliation
University of Amsterdam
Official's Role
Study Director
Facility Information:
Facility Name
University of Amsterdam, Department of Clinical Psychology
City
Amsterdam
ZIP/Postal Code
1018 XA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
30795749
Citation
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.
Results Reference
derived

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Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia

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