Virtual Reality Exposure Therapy in Agoraphobic Participants

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Exposure Therapy in Agoraphobic Participants

Conditions
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Panic Disorder, Agoraphobia

Intervention / Treatment
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* Behavioral: Virtual Reality Exposure Therapy for agoraphobic participants
* Behavioral: Standard exposure in vivo for agoraphobic participants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VRET<br>Virtual Reality Exposure Therapy for agoraphobic participants | Behavioral: Virtual Reality Exposure Therapy for agoraphobic participants<br>* 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<br>|
| Active Comparator: Exposure in vivo<br>Standard exposure in vivo for panic disorder | Behavioral: Standard exposure in vivo for agoraphobic participants<br>* 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)<br>|
| No Intervention: Wait-list control<br>Wait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panic Disorder and Agoraphobia, Virtual Reality Exposure Therapy