Panic; AgoraphobiaNCT03101332
Virtual Reality for Panic Disorder With Agoraphobia
A study testing Virtual Reality cognitive behavior therapy in people with Panic; Agoraphobia, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic; Agoraphobia
- What is being tested?
- Virtual Reality cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSweden
- Study dates
- 1 May 2017to 18 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Gustavsberg primary care center
Gustavsberg, Stockholm County, 13440
Karolinska Institutet
Stockholm, 17177
About this study
Official title: Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial
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.
- Conditions
- Panic; Agoraphobia
- Being tested
- Virtual Reality cognitive behavior therapy
- Medical subject headings
- Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality cognitive behavior therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-CBT | Experimental | Virtual Reality cognitive behavior therapy. 10-12 sessions of individual Cognitive Behavior Therapy with exposure tasks carried out through Virtual Reality. Receives: Behavioral: Virtual Reality cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility Inventory
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Measured: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Secondary outcomes (4)
Panic disorder severity scale
Change at post-treatment (10 weeks), 6-month follow-up, and 12 month follow-up compared to baseline
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 May 2017
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic; AgoraphobiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
- Investigators
- Erik Hedman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101332
- Sponsor's protocol ID
- VR for panic with agoraphobia
- Status last verified
- Oct 2020
- First submitted
- 30 Mar 2017
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Panic Disorder With Agoraphobia: a Clinical Trial
- ClinicalTrials.gov ID
- NCT03101332
- Acronym / sponsor ID
- VR for panic with agoraphobia
- Conditions
- Panic; Agoraphobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR-CBT | Experimental | Behavioral: Virtual Reality cognitive behavior therapyVirtual Reality cognitive behavior therapy. 10-12 sessions of individual Cognitive Behavior Therapy with exposure tasks carried out through Virtual Reality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality cognitive behavior therapyCognitive 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. | Behavioural | VR-CBT |
Primary outcome
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
4 secondary outcomes
Panic disorder severity scale
Time frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Patient Health Questionnaire
Time frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
World Health Organisation Disability Assessment Schedule
Time frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
The World Health Organisation Quality of Life
Time frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Hedman, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality cognitive behavior therapy in people with Panic; Agoraphobia, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility Inventory (time frame: Baseline, post-treatment (10 weeks), 6-month follow-up, 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.