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Trial record 87 of 179 for:    "Panic Disorder"

Virtual Reality for Panic Disorder With Agoraphobia

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ClinicalTrials.gov Identifier: NCT03101332
Recruitment Status : Unknown
Verified April 2017 by Erik Hedman, Karolinska Institutet.
Recruitment status was:  Not yet recruiting
First Posted : April 5, 2017
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Panic; Agoraphobia Behavioral: Virtual Reality cognitive behavior therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial
Estimated Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder

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.





Primary Outcome Measures :
  1. Mobility Inventory [ Time Frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up ]
    Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline


Secondary Outcome Measures :
  1. Panic disorder severity scale [ Time Frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up ]
    Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline

  2. Patient Health Questionnaire [ Time Frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up ]
    Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline

  3. World Health Organisation Disability Assessment Schedule [ Time Frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up ]
    Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline

  4. The World Health Organisation Quality of Life [ Time Frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up ]
    Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline


Other Outcome Measures:
  1. Presence Questionnaire [ Time Frame: Week 1, week, 2, week3, week 4, week 5, week 6, week 7, week 8, week 9, week 10 ]
    Means and standard deviations will be presented. No change is hypothesized for this measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101332


Contacts
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Contact: Erik Hedman, PhD 709667074 kire.hedman@ki.se

Locations
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Sweden
Gustavsberg primary care center
Gustavsberg, Stockholm, Sweden, 13440
Karolinska Institutet
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Erik Hedman, PhD Karolinska Institutet

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Responsible Party: Erik Hedman, Principal investigator, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03101332     History of Changes
Other Study ID Numbers: VR for panic with agoraphobia
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Panic Disorder
Agoraphobia
Anxiety Disorders
Mental Disorders