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Completed

NCT Number: NCT03101332

Virtual Reality for Panic Disorder With Agoraphobia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustavsberg primary care center, Gustavsberg, Stockholm County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality cognitive behavior therapy

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 5, 2017
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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