Virtual Reality for Panic Disorder With Agoraphobia

Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Panic; Agoraphobia
• Intervention / Treatment: Behavioral: Virtual Reality cognitive behavior therapy

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Institutet
  • Stockholm
    • Gustavsberg, Stockholm, Sweden, 13440
      • Gustavsberg primary care center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: VR-CBT; 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; 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.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik Hedman, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): June 18, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (Actual): April 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; Agoraphobia
• Other Study ID Numbers: VR for panic with agoraphobia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No