An interventional study of Virtual Reality cognitive behavior therapy in Panic; Agoraphobia, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-30.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
Exclusion:
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.
Mobility Inventory
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
Panic disorder severity scale
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
Patient Health Questionnaire
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
World Health Organisation Disability Assessment Schedule
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
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
Time frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Presence Questionnaire
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
Plan to share: No
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet