Virtual Reality Exposure Therapy in Agoraphobic Participants
1 other identifier
interventional
55
1 country
1
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:
- 1.enhanced VRET making use of the latest avatar technology with
- 2.exposure in vivo in agoraphobic participants
- 3.wait-list control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedSeptember 13, 2018
September 1, 2018
2.7 years
August 11, 2008
September 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT)
Assessed at pre- and post-treatment and 6-12 months follow-up
Secondary Outcomes (1)
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 PDSS and PAI will be administered every therapy session
Study Arms (3)
VRET
EXPERIMENTALVirtual Reality Exposure Therapy for agoraphobic participants
Exposure in vivo
ACTIVE COMPARATORStandard exposure in vivo for panic disorder
Wait-list control
NO INTERVENTIONWait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting.
Interventions
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
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Amsterdam
Amsterdam, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul MG Emmelkamp, Professor
University of Amsterdam
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 14, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2011
Study Completion
January 1, 2012
Last Updated
September 13, 2018
Record last verified: 2018-09