Virtual Reality for Panic Disorder With Agoraphobia

Panic; Agoraphobia Clinical Trial

Official title:

Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101332
• Other study ID #: VR for panic with agoraphobia
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 18, 2019

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 18, 2019
• Est. primary completion date: June 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agoraphobia
• Panic Disorder
• Panic; Agoraphobia

Intervention

Behavioral:
• Virtual Reality cognitive behavior therapy
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.

Locations

Country	Name	City	State
Sweden	Gustavsberg primary care center	Gustavsberg	Stockholm
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence Questionnaire	Means and standard deviations will be presented. No change is hypothesized for this measure	Week 1, week, 2, week3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Primary	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	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
Secondary	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
Secondary	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
Secondary	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