Panic DisorderNCT00734370
Virtual Reality Exposure Therapy in Agoraphobic Participants
A study testing Virtual Reality Exposure Therapy for agoraphobic participants and Standard exposure in vivo for agoraphobic participants in people with Panic Disorder and Agoraphobia, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders, particularly for specific phobias as fear of heights and fear of flying (e.g. Powers \& Emmelkamp, 2008). Recent technological advances (e.g. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder, Agoraphobia
- What is being tested?
- Virtual Reality Exposure Therapy for agoraphobic participants and Standard exposure in vivo for agoraphobic participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2008to Jan 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A full diagnosis of panic disorder with agoraphobia according to the DSM-IV
- Between the ages of 18-65 years
- Sufficient fluency in Dutch to complete treatment and research protocol
Who cannot join
- Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, pacemaker)
- Current use of Beta-blockers
- Current use of tranquilizers (Benzodiazepines)
- Unstable psychotropic medication
- Substance dependence
- Psychosis
Show all 12Show fewer
- Depression with suicidal ideation
- Posttraumatic Stress Disorder
- Dementia or other severe cognitive impairment
- Bipolar Disorder
- Borderline Personality Disorder
- Anti-social Personality Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders, particularly for specific phobias as fear of heights and fear of flying (e.g. Powers \& Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable. Therefore, the aim of the present research proposal is to investigate the comparative efficacy of:
- enhanced VRET making use of the latest avatar technology with
- exposure in vivo in agoraphobic participants
- wait-list control.
- Conditions
- Panic Disorder, Agoraphobia
- Being tested
- Virtual Reality Exposure Therapy for agoraphobic participants, Standard exposure in vivo for agoraphobic participants
- Keywords
- Panic Disorder and Agoraphobia, Virtual Reality Exposure Therapy
- 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 Exposure Therapy for agoraphobic participantsBehavioural
This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of
- Psycho-education, breathing training and cognitive restructuring
- Virtual reality Exposure to agoraphobic situations and interoceptive exposure
- Relapse prevention
Standard exposure in vivo for agoraphobic participantsBehavioural
This intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of
- Psycho-education, breathing training and cognitive restructuring
- Standard exposure in vivo to agoraphobic situations and interoceptive exposure
- Relapse prevention (according to the protocol of Craske \& Barlow)
| Study group | Role | What they receive |
|---|---|---|
| VRET | Experimental | Virtual Reality Exposure Therapy for agoraphobic participants Receives: Behavioral: Virtual Reality Exposure Therapy for agoraphobic participants |
| Exposure in vivo | Active comparator | Standard exposure in vivo for panic disorder Receives: Behavioral: Standard exposure in vivo for agoraphobic participants |
| Wait-list control | No intervention | Wait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT)
Measured: Assessed at pre- and post-treatment and 6-12 months follow-up
Secondary outcomes (1)
Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Panic Disorder Severity Scale (PDSS); Agoraphobic Cognitions Questionnaire (ACQ); Bodily Sensations Questionnaire (BSQ); Panic Appraisal Inventory (PAI)
Process measures are taken prior to treatment, after the fourth treatment session and at post-treatment. The same measures will also be taken at 6 months follow-up.
Measured: Process measures: are taken prior to treatment, after the fourth treatment session and at post-treatment. The PDSS and PAI will be administered every therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJan 2012
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.
- 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul M.G.Emmelkamp, VU University of Amsterdam
- Investigators
- Paul MG Emmelkamp, Professor, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00734370
- Sponsor's protocol ID
- KP-2008-518
- Status last verified
- Sep 2018
- First submitted
- 11 Aug 2008
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy in Agoraphobic Participants
- ClinicalTrials.gov ID
- NCT00734370
- Acronym / sponsor ID
- KP-2008-518
- Conditions
- Panic Disorder, Agoraphobia
- Keywords
- Panic Disorder and Agoraphobia, Virtual Reality Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 14 Aug 2008 (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.
Virtual Reality Exposure Therapy (VRET) is an effective treatment for anxiety disorders, particularly for specific phobias as fear of heights and fear of flying (e.g. Powers \& Emmelkamp, 2008). Recent technological advances (e.g. more realistic avatars) make research into the efficacy of VRET for participants with elevated agoraphobic symptoms desirable. Therefore, the aim of the present research proposal is to investigate the comparative efficacy of:
- enhanced VRET making use of the latest avatar technology with
- exposure in vivo in agoraphobic participants
- wait-list control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VRET | Experimental | Behavioral: Virtual Reality Exposure Therapy for agoraphobic participantsVirtual Reality Exposure Therapy for agoraphobic participants |
| Exposure in vivo | Active comparator | Behavioral: Standard exposure in vivo for agoraphobic participantsStandard exposure in vivo for panic disorder |
| Wait-list control | No intervention | –Wait-list control group. Participants from this arm are randomized to the two active conditions after 10 weeks of waiting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A full diagnosis of panic disorder with agoraphobia according to the DSM-IV
- Between the ages of 18-65 years
- Sufficient fluency in Dutch to complete treatment and research protocol
Key exclusion criteria (12 listed)
- Presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, pacemaker)
- Current use of Beta-blockers
- Current use of tranquilizers (Benzodiazepines)
- Unstable psychotropic medication
- Substance dependence
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 Exposure Therapy for agoraphobic participantsThis intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of * Psycho-education, breathing training and cognitive restructuring * Virtual reality Exposure to agoraphobic situations and interoceptive exposure * Relapse prevention | Behavioural | VRET |
| Standard exposure in vivo for agoraphobic participantsThis intervention is comprised of 10 sessions of cognitive behavior therapy for panic disorder and agoraphobia with components of * Psycho-education, breathing training and cognitive restructuring * Standard exposure in vivo to agoraphobic situations and interoceptive exposure * Relapse prevention (according to the protocol of Craske \& Barlow) | Behavioural | Exposure in vivo |
Primary outcome
Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT)
Time frame: Assessed at pre- and post-treatment and 6-12 months follow-up
1 secondary outcome
Beck Anxiety Inventory (BAI); Anxiety Sensitivity Inventory (ASI); Beck Depression Inventory (BDI); Panic Disorder Severity Scale (PDSS); Agoraphobic Cognitions Questionnaire (ACQ); Bodily Sensations Questionnaire (BSQ); Panic Appraisal Inventory (PAI)
Time frame: Process measures: are taken prior to treatment, after the fourth treatment session and at post-treatment. The PDSS and PAI will be administered every therapy session
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 13 Sep 2018.
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.
Paul MG Emmelkamp, Professor principal investigator
University of Amsterdam
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 Exposure Therapy for agoraphobic participants and Standard exposure in vivo for agoraphobic participants in people with Panic Disorder and Agoraphobia, run by VU University of Amsterdam at 1 site in Netherlands.
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 12 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 13 Sep 2018. 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 Netherlands. 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?
Panic Disorder Severity Scale (PDSS); Mobility Inventory for Agoraphobia (MI); Behavioural Avoidance Test (BAT) (time frame: Assessed at pre- and post-treatment and 6-12 months 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 13 Sep 2018.