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Virtual Reality Exposure Therapy in Agoraphobic Participants

Primary Purpose

Panic Disorder, Agoraphobia

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

About this trial

This is an interventional treatment trial for Panic Disorder focused on measuring Panic Disorder and Agoraphobia, Virtual Reality Exposure Therapy

Eligibility Criteria

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

Inclusion Criteria:

  • A full diagnosis of panic disorder with agoraphobia according to the DSM-IV
  • Between the ages of 18-65 years
  • Sufficient fluency in Dutch to complete treatment and research protocol

Exclusion Criteria:

  • Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, pacemaker)
  • Current use of Beta-blockers
  • Current use of tranquilizers (Benzodiazepines)
  • Unstable psychotropic medication
  • Substance dependence
  • Psychosis
  • Depression with suicidal ideation
  • Posttraumatic Stress Disorder
  • Dementia or other severe cognitive impairment
  • Bipolar Disorder
  • Borderline Personality Disorder
  • Anti-social Personality Disorder

Sites / Locations

  • University of Amsterdam

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

VRET

Exposure in vivo

Wait-list control

Arm Description

Virtual Reality Exposure Therapy for agoraphobic participants

Standard exposure in vivo for panic disorder

Wait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting.

Outcomes

Primary Outcome Measures

Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT)

Secondary Outcome Measures

Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Panic Disorder Severity Scale (PDSS); Agoraphobic Cognitions Questionnaire (ACQ); Bodily Sensations Questionnaire (BSQ); Panic Appraisal Inventory (PAI)
Process measures are taken prior to treatment, after the fourth treatment session and at post-treatment. The same measures will also be taken at 6 months follow-up.

Full Information

First Posted
August 11, 2008
Last Updated
September 11, 2018
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT00734370
Brief Title
Virtual Reality Exposure Therapy in Agoraphobic Participants
Official Title
Virtual Reality Exposure Therapy in Agoraphobic Participants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2012 (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
Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders, particularly for specific phobias as fear of heights and fear of flying (e.g. Powers & Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable. Therefore, the aim of the present research proposal is to investigate the comparative efficacy of: enhanced VRET making use of the latest avatar technology with exposure in vivo in agoraphobic participants wait-list control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder, Agoraphobia
Keywords
Panic Disorder and Agoraphobia, Virtual Reality Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VRET
Arm Type
Experimental
Arm Description
Virtual Reality Exposure Therapy for agoraphobic participants
Arm Title
Exposure in vivo
Arm Type
Active Comparator
Arm Description
Standard exposure in vivo for panic disorder
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Wait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy for agoraphobic participants
Intervention Description
This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of Psycho-education, breathing training and cognitive restructuring Virtual reality Exposure to agoraphobic situations and interoceptive exposure Relapse prevention
Intervention Type
Behavioral
Intervention Name(s)
Standard exposure in vivo for agoraphobic participants
Intervention Description
This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of Psycho-education, breathing training and cognitive restructuring Standard exposure in vivo to agoraphobic situations and interoceptive exposure Relapse prevention (according to the protocol of Craske & Barlow)
Primary Outcome Measure Information:
Title
Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT)
Time Frame
Assessed at pre- and post-treatment and 6-12 months follow-up
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Panic Disorder Severity Scale (PDSS); Agoraphobic Cognitions Questionnaire (ACQ); Bodily Sensations Questionnaire (BSQ); Panic Appraisal Inventory (PAI)
Description
Process measures are taken prior to treatment, after the fourth treatment session and at post-treatment. The same measures will also be taken at 6 months follow-up.
Time Frame
Process measures: are taken prior to treatment, after the fourth treatment session and at post-treatment. The PDSS and PAI will be administered every therapy session

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: A full diagnosis of panic disorder with agoraphobia according to the DSM-IV Between the ages of 18-65 years Sufficient fluency in Dutch to complete treatment and research protocol Exclusion Criteria: Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, pacemaker) Current use of Beta-blockers Current use of tranquilizers (Benzodiazepines) Unstable psychotropic medication Substance dependence Psychosis Depression with suicidal ideation Posttraumatic Stress Disorder Dementia or other severe cognitive impairment Bipolar Disorder Borderline Personality Disorder Anti-social Personality Disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul MG Emmelkamp, Professor
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Amsterdam
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

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Virtual Reality Exposure Therapy in Agoraphobic Participants

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