Clinical trial NCT03101332: Virtual Reality for Panic Disorder With Agoraphobia
Official title: Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Panic; Agoraphobia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mobility Inventory
timeFrame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Secondary outcomes:
measure: Panic disorder severity scale
timeFrame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
measure: Patient Health Questionnaire
timeFrame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
measure: World Health Organisation Disability Assessment Schedule
timeFrame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
measure: The World Health Organisation Quality of Life
timeFrame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Other outcomes:
measure: Presence Questionnaire
timeFrame: Week 1, week, 2, week3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Locations:
city: Gustavsberg
country: Sweden
facility: Gustavsberg primary care center
state: Stockholm
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik Hedman, PhD
role: PRINCIPAL_INVESTIGATOR
References: