Panic DisorderNCT00129610
Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
A study testing Virtual Reality Therapy and Cognitive Behavior Therapy in people with Panic Disorder and Agoraphobia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works suggest that the combination of the two methods… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder, Agoraphobia
- What is being tested?
- Virtual Reality Therapy and Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2004to not given
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The study includes 90 patients, aged from 18 to 60, with DSM-4 panic disorder with agoraphobia.
- Patients should not be clinically depressed and present a Hamilton Scale of Depression score of less than 18.
Who cannot join
- Patients with active medication (antidepressants, neuroleptics, mood stabilizers, benzodiazepines, Kava Kava, or hypericum) or street drugs. Minor herbal medicine is tolerated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works suggest that the combination of the two methods are clinically effective. Patients receive a two-page information leaflet about the trial and sign an informed consent. After the first evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12 sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After three months the waiting list is randomized to VRT or CBT. The follow-up is one year from entry into the active part of the trial.
- Conditions
- Panic Disorder, Agoraphobia
- Being tested
- Virtual Reality Therapy, Cognitive Behavior Therapy
- Keywords
- Agoraphobia, panic disorder, Virtual Reality Therapy, Cognitive Behavior Therapy, cognition, spatial cognition, PANIC DISORDER WITH AGORAPHOBIA
- Medical subject headings
- Panic Disorder, Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TherapyBehavioural
Cognitive Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire
Secondary outcomes (12)
Pre-test, post-test, 6 months and one year
Panic Disorder Severity Scale
Agoraphobic cognitions
Panic, phobia, generalized anxiety
Trait State Anxiety Inventory (STAI)
Hamilton Anxiety Scale
Dissociative experiences
Beck Depression Inventory
Quality of Life, handicap
Spatial cognition: Rey's Figure and Rod and Frame test
Therapeutic expectations (pre-test)
Therapeutic relationship (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Jean COTTRAUX, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129610
- Sponsor's protocol ID
- 2002.307
- Status last verified
- Apr 2007
- First submitted
- 11 Aug 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Controlled Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia
- ClinicalTrials.gov ID
- NCT00129610
- Acronym / sponsor ID
- 2002.307
- Conditions
- Panic Disorder, Agoraphobia
- Keywords
- Agoraphobia, panic disorder, Virtual Reality Therapy, Cognitive Behavior Therapy, cognition, spatial cognition, PANIC DISORDER WITH AGORAPHOBIA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2004
- First posted
- 12 Aug 2005 (estimated)
- 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.
The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works suggest that the combination of the two methods are clinically effective. Patients receive a two-page information leaflet about the trial and sign an informed consent. After the first evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12 sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After three months the waiting list is randomized to VRT or CBT. The follow-up is one year from entry into the active part of the trial.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The study includes 90 patients, aged from 18 to 60, with DSM-4 panic disorder with agoraphobia.
- Patients should not be clinically depressed and present a Hamilton Scale of Depression score of less than 18.
Key exclusion criteria (1 listed)
- Patients with active medication (antidepressants, neuroleptics, mood stabilizers, benzodiazepines, Kava Kava, or hypericum) or street drugs. Minor herbal medicine is tolerated.
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 Therapy | Behavioural | – |
| Cognitive Behavior Therapy | Behavioural | – |
Primary outcome
The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire
12 secondary outcomes
Pre-test, post-test, 6 months and one year
Panic Disorder Severity Scale
Agoraphobic cognitions
Panic, phobia, generalized anxiety
Trait State Anxiety Inventory (STAI)
Hamilton Anxiety Scale
Dissociative experiences
Beck Depression Inventory
Quality of Life, handicap
Spatial cognition: Rey's Figure and Rod and Frame test
Therapeutic expectations (pre-test)
Therapeutic relationship (post-test)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
Related trials for Panic Disorder
Not yet recruiting
Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial
Depression - Major Depressive Disorder, Generalised Anxiety Disorder
Not yet recruiting
A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
Panic Disorder, Agoraphobia
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Active, not recruiting
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Recruiting
Qigong and Multicomponent Exercise in Panic Disorder
Panic Disorder, Panic Disorder (With or Without Agoraphobia)
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.
Jean COTTRAUX, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Therapy and Cognitive Behavior Therapy in people with Panic Disorder and Agoraphobia, run by Hospices Civils de Lyon at 1 site in France.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
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?
The response criterion is a decrease of 50% of the agoraphobia subscore on the Fear Questionnaire. 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 27 Apr 2007.