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Virtual Reality for Panic Disorder With Agoraphobia

Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03101332
Enrollment
12
Registered
2017-04-05
Start date
2017-05-01
Completion date
2019-06-18
Last updated
2020-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Panic; Agoraphobia

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.

Interventions

BEHAVIORALVirtual 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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Mobility InventoryBaseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-upChange at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline

Secondary

MeasureTime frameDescription
Panic disorder severity scaleBaseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-upChange at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Patient Health QuestionnaireBaseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-upChange at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
World Health Organisation Disability Assessment ScheduleBaseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-upChange at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
The World Health Organisation Quality of LifeBaseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-upChange at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline

Other

MeasureTime frameDescription
Presence QuestionnaireWeek 1, week, 2, week3, week 4, week 5, week 6, week 7, week 8, week 9, week 10Means and standard deviations will be presented. No change is hypothesized for this measure

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026