Virtual Reality for Panic Disorder With Agoraphobia

Study Overview
=================
Brief Summary
-----------------
Panic disorder with agoraphobia (PDA) is associated with considerable personal distress, functional disability and societal costs. A large number of studies have shown that Cognitive Behavior Therapy (CBT) is a highly effective treatment for PDA. However, the CBT-protocols proven to be most effective involves repeated exposure to the particular environments the agoraphobic patient fears such as trains, tunnels, lifts and shops. This cause great practical problems for health care services as such therapeutic efforts involves spending considerable time outside the clinic. For primary care services this is particularly challenging due to the large number of patients expected to be seen. Normally clinicians meet up to 7 patients daily which makes it almost practically impossible to offer 2-hour sessions, which is necessary to carry out the relevant exposure tasks. Hence, the treatment proven to be most effective, which primary care services are commissioned to deliver, is too comprehensive and time consuming to be applied in real practice. The investigators believe that a possible solution to the above problem is to provide evidence-based CBT but with the exposure components carried out through Virtual Reality (VR) rather than in vivo. Some research has already been done with virtual reality and exposure therapy for anxiety disorders with promising results. The aim of this pilot study is to treat patients with agoraphobia with or with a history of panic disorder with a standardized exposure-based CBT-protocol through VR. The virtual environments that are used for the study are live sequences filmed in 360°. The investigators hypothesize that CBT with VR will be effective and lead to improvements on measures of panic disorder and agoraphobia.

Official Title
-----------------
Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial

Conditions
-----------------
Panic; Agoraphobia

Intervention / Treatment
-----------------
* Behavioral: Virtual Reality cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: A primary diagnosis of Agoraphobia with or with a history of panic disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5). Minimum 18 years of age. Able to read and write in Swedish Exclusion: Other primary axis-I disorder Ongoing substance abuse or addiction Current or previous episode of psychosis or bipolar disorder Severe major depressive disorder: Moderate to severe suicidal risk Non-stable antidepressant medication (changed during the last month) or not agreeing to keep dosage constant throughout the study Ongoing concurrent psychological treatment Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy for agoraphobia during the recent year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-CBT<br>Virtual Reality cognitive behavior therapy. 10-12 sessions of individual Cognitive Behavior Therapy with exposure tasks carried out through Virtual Reality. | Behavioral: Virtual Reality cognitive behavior therapy<br>* Cognitive interventions targeted to change catastrophic misinterpretations of the physiological symptoms that occur during a panic attack. Exposure via Virtual Reality to filmed sequences of environments typically feared by agoraphobic patients such as underground station/train, a tunnel, a lift and a public square, as well as exposure to the feared symptoms that occur in a typical panic attack. Interventions are delivered by a psychologist in face-to-face sessions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility Inventory | Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline | Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Panic disorder severity scale | Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline | Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up | 
| Patient Health Questionnaire | Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline | Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up | 
| World Health Organisation Disability Assessment Schedule | Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline | Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up | 
| The World Health Organisation Quality of Life | Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline | Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up |