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Virtual Reality for Panic Disorder With Agoraphobia

Primary Purpose

Panic; Agoraphobia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Virtual Reality cognitive behavior therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic; Agoraphobia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gustavsberg primary care center
  • Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VR-CBT

Arm Description

Virtual Reality cognitive behavior therapy. 10-12 sessions of individual Cognitive Behavior Therapy with exposure tasks carried out through Virtual Reality.

Outcomes

Primary Outcome Measures

Mobility Inventory
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline

Secondary Outcome Measures

Panic disorder severity scale
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Patient Health Questionnaire
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
World Health Organisation Disability Assessment Schedule
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
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

Full Information

First Posted
March 30, 2017
Last Updated
October 29, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03101332
Brief Title
Virtual Reality for Panic Disorder With Agoraphobia
Official Title
Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
June 18, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic; Agoraphobia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR-CBT
Arm Type
Experimental
Arm Description
Virtual Reality cognitive behavior therapy. 10-12 sessions of individual Cognitive Behavior Therapy with exposure tasks carried out through Virtual Reality.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality cognitive behavior therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mobility Inventory
Description
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Time Frame
Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Secondary Outcome Measure Information:
Title
Panic disorder severity scale
Description
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Time Frame
Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Title
Patient Health Questionnaire
Description
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Time Frame
Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Title
World Health Organisation Disability Assessment Schedule
Description
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Time Frame
Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Title
The World Health Organisation Quality of Life
Description
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Time Frame
Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Other Pre-specified Outcome Measures:
Title
Presence Questionnaire
Description
Means and standard deviations will be presented. No change is hypothesized for this measure
Time Frame
Week 1, week, 2, week3, week 4, week 5, week 6, week 7, week 8, week 9, week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Hedman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gustavsberg primary care center
City
Gustavsberg
State/Province
Stockholm
ZIP/Postal Code
13440
Country
Sweden
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality for Panic Disorder With Agoraphobia

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