Phobic DisordersCTRLSTRESSNCT02020824
Virtual Reality and Concept of Control in the Treatment of Acrophobia
A study testing Exposure to anxiogenous environments, Imagery with functional MRI initial and Imagery with PET-scanner initial in people with Phobic Disorders, run by Qualissima at 1 site in France.
Trial summary
Virtual reality is currently used as a therapeutic strategy in common phobia as agoraphobia or acrophobia, since it permits to have a better control (on occurrence of events or on the environment) during the therapy than in "in vivo" therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Phobic Disorders
- What is being tested?
- Exposure to anxiogenous environments, Imagery with functional MRI initial and Imagery with PET-scanner initial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jul 2017
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 60 years old
- Male or female
- All subjects will be fluent in French.
- Fully informed and freely given, signed Informed consent in written form.
- Patient / Subject affiliated or beneficiary of a social/health security insurance.
- Patients not hospitalized suffering from acrophobia (according to DSM-IV, APA 2000).
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- Patients receiving pharmacotherapy (anxiolytics, hypnotics, etc.) may be included provided they are stabilized on treatment for at least 8 weeks.
- Score inferior to 6 at the Behavioural Avoidance Test
- People not hospitalized showing no sign of acrophobia.
- Score superior or equal to 10 at the Behavioural Avoidance Test.
Who cannot join
- Pregnant woman (urine and blood β -HCG test) or lactating (contraindication to PET-scan).
- Women of childbearing potential without effective contraception (contraindication to PET-scan).
- Subject participating in another research evaluating other treatments including a period of exclusion still ongoing.
- Persons under guardianship and adults subject submitted to a measure of legal protection or unable to consent.
- Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent under Articles L. 3212-1 and L. 3213-1 that do not fall under the provisions of Article L. 1121-8 and admitted to a health or social institution for purposes other than research.
- People with a non-stabilized diabetes (contraindication to PET-scan).
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- Addictions to alcohol or drugs.
- Persons suffering from claustrophobia.
- Contraindications to fMRI.
- People with hearing loss.
- Strong visual impairment (> 5 diopters) not corrected by contact lenses.
- Patients continuing psychotherapy.
- Patients suffering from other neurological disorders or comorbid psychiatric diseases than acrophobia.
- Patients suffering from severe organic disorders that could disable or disrupt the therapeutic process.
- The concomitant drugs at inclusion should not be modified or discontinued during the study.
- No psychotherapy should be initiated during the study.
- Subjects with a known psychiatric or neurological disorders, diagnosed for depression, with emotional disorders affecting their perception of the environment, or taking a medication that may affect the auditory and visual perception, concentration or emotions.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille
Marseille, 13005
Eric MALBOS, MD, 0491435552 ext. +33, eric.malbos@ap-hm.fr
Eric MALBOS, MD
About this study
Official title: Virtual Reality and Concept of Control in the Treatment of Acrophobia by Exposure to Virtual Environments: Comparative Test
Virtual reality is currently used as a therapeutic strategy in common phobia as agoraphobia or acrophobia, since it permits to have a better control (on occurrence of events or on the environment) during the therapy than in "in vivo" therapy. Our hypothesis here is that we can improves the therapeutic effects of the virtual exposure by giving control to acrophobic patients during their exposure.
Read the detailed description
The study is based on the exposure of acrophobic patients to virtual environments. During the study, several groups of patients will be distributed according to different conditions: exposure to anxiogenous virtual environments and exposure with the ability to control and secure the anxiogenous virtual environments.
The interest of this project is to improve therapy by exposure to virtual reality. Our project offers a systematic therapeutic approach (using virtual reality and the concept of control) where current therapy are too often approximate. We aim to demonstrate the effectiveness of the control of virtual environments on symptomatic and psychophysiological levels, to evaluate the adoption of these methods in the couple patients-caregivers and also to understand the brain mechanisms (including those prefrontal) involved in this therapy.
- Conditions
- Phobic Disorders
- Being tested
- Exposure to anxiogenous environments, Imagery with functional MRI initial, Imagery with PET-scanner initial, Imagery with functional MRI final, Imagery with PET-scanner final
- Keywords
- Acrophobia
- Medical subject headings
- Phobic Disorders, Acrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to anxiogenous environmentsBehavioural
The anxiogenous environments are defined by several levels of possible anxiety classified progressively and independently by each patient at the beginning of the study. The exposure is applied during the 8 sessions for each of the arms "Exposure to anxiogenous environments (with or without control)".
Imagery with functional MRI initialOther
Subjects will be submitted to 1 session of fMRI during their first visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
Imagery with PET-scanner initialOther
Subjects will be submitted to 1 session of PET-scanner during their first visit, in order to measure the synaptic activity during the exposure to anxiogenous environments.
Imagery with functional MRI finalOther
Patients will be submitted to 1 session of fMRI during a follow-up visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
Imagery with PET-scanner finalOther
Patients will be submitted to 1 session of PET-scanner during a follow-up visit, in order to measure the synaptic activity during the exposure to anxiogenous environments.
| Study group | Role | What they receive |
|---|---|---|
| Exposure without control | Active comparator | Exposure to anxiogenous environments: 20 acrophobic patients will be exposed during 8 sessions to anxiogenous environments without control.
Imagery with functional MRI initial. Imagery with functional MRI final. Imagery with PET-scanner initial. Imagery with PET-scanner final. Receives: Behavioral: Exposure to anxiogenous environments; Other: Imagery with functional MRI initial; Other: Imagery with PET-scanner initial; Other: Imagery with functional MRI final; Other: Imagery with PET-scanner final |
| Exposure with control | Experimental | Exposure to anxiogenous environments: 20 acrophobic patients will be exposed during 8 sessions to anxiogenous environments with the ability to control and secure these.
Imagery with functional MRI initial. Imagery with functional MRI final. Imagery with PET-scanner initial. Imagery with PET-scanner final. Receives: Behavioral: Exposure to anxiogenous environments; Other: Imagery with functional MRI initial; Other: Imagery with PET-scanner initial; Other: Imagery with functional MRI final; Other: Imagery with PET-scanner final |
| Healthy volunteers | Other | 20 healthy volunteers will be submitted to the same initial measurements in order to explore potential differences between them and the patients.
Imagery with functional MRI initial. Imagery with PET-scanner initial. Receives: Other: Imagery with functional MRI initial; Other: Imagery with PET-scanner initial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioural Avoidance Test (BAT)
Objective measure of behavior scored on 10 points in response to a virtual environment representing a situation feared by acrophobic patients. This virtual environment is a flat landscape with a platform overlooking a canyon of 800 meters.
Measured: 1 year (4 times)
Secondary outcomes (14)
Brain activity (functional MRI)
Anatomical and functional : brain activity in several cortical and subcortical areas with fMRI (BOLD signal intensity)
Measured: 12 weeks (2 times)
Synaptic activity (PET-scan)
Metabolic and functional : synaptic activity with PET scanner
Measured: 12 weeks (2 times)
Cognitive measurements
Attentional bias (DOT test)
Measured: 12 weeks (2 times)
Cognitive measurements
Emotional valence (emotional congruence task)
Measured: 12 weeks (2 times)
Cognitive measurements
Questionnaire on acrophobia (AQ: Acrophobia Questionnaire)
Measured: 1 year (4 times)
Cognitive measurements
Questionnaire on acrophobia (ATHQ: Attitude Towards Heights Questionnaire)
Measured: 1 year (4 times)
Cognitive measurements
Questionnaire on anxiety (STAI: Spielberger Trait Anxiety Inventory)
Measured: 1 year (4 times)
Cognitive measurements
Questionnaire on depression (BDI: Beck Depression Inventory)
Measured: 1 year (4 times)
Quality of life
Quality of Life (SF-12: Medical Outcome Study Short Form)
Measured: 1 year (4 times)
Cognitive measurements
During the 8 sessions of exposure to virtual reality: Questionnaires on anxiety (SUD: Subjective Unit of Discomfort)
Measured: 10 weeks (8 times)
Cognitive measurements
During the 8 sessions of exposure to virtual reality: Progression recorded and time to progression from one environment to another during sessions (number of environments completed, time of execution, others ..)
Measured: 10 weeks (8 times)
Ergonomy
During the 8 sessions of exposure to virtual reality: Questionnaire on the applicability / realism / ergonomy (PQ: Questionnaire on the state of Presence).
Measured: 10 weeks (8 times)
Psychophysiological
During the 8 sessions of exposure to virtual reality: Psychophysiological objective measurements during exposure to virtual reality (electrodermal activity, electrocardiography, breathing rate)
Measured: 10 weeks (8 times)
Adverse events
Assessment and description of all the occurrence of adverse events during the study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startApr 2014
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobic DisordersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qualissima
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Eric MALBOS, MD, Principal investigator, Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU MarseilleDaniel MESTRE, PhD, Study chair, DR2, UMR 6233 CNRS; Université de la Méditerranée; CRVMStéphanie KHALFA, PhD, Study director, CR1, Institut des Neurosciences Timone, Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020824
- Sponsor's protocol ID
- CTRLSTRESS
- Other IDs
- 2013-A01280-45 ID-RCB
- Acronym
- CTRLSTRESS
- Status last verified
- Oct 2015
- First submitted
- 19 Dec 2013
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Concept of Control in the Treatment of Acrophobia by Exposure to Virtual Environments: Comparative Test
- ClinicalTrials.gov ID
- NCT02020824
- Acronym / sponsor ID
- CTRLSTRESS / CTRLSTRESS
- Conditions
- Phobic Disorders
- Keywords
- Acrophobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- QualissimaUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- Apr 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 25 Dec 2013 (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 is currently used as a therapeutic strategy in common phobia as agoraphobia or acrophobia, since it permits to have a better control (on occurrence of events or on the environment) during the therapy than in "in vivo" therapy. Our hypothesis here is that we can improves the therapeutic effects of the virtual exposure by giving control to acrophobic patients during their exposure.
Detailed description
The study is based on the exposure of acrophobic patients to virtual environments. During the study, several groups of patients will be distributed according to different conditions: exposure to anxiogenous virtual environments and exposure with the ability to control and secure the anxiogenous virtual environments.
The interest of this project is to improve therapy by exposure to virtual reality. Our project offers a systematic therapeutic approach (using virtual reality and the concept of control) where current therapy are too often approximate. We aim to demonstrate the effectiveness of the control of virtual environments on symptomatic and psychophysiological levels, to evaluate the adoption of these methods in the couple patients-caregivers and also to understand the brain mechanisms (including those prefrontal) involved in this therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposure without control | Active comparator | Behavioral: Exposure to anxiogenous environments, Other: Imagery with functional MRI initial, Other: Imagery with PET-scanner initial, Other: Imagery with functional MRI final, Other: Imagery with PET-scanner finalExposure to anxiogenous environments: 20 acrophobic patients will be exposed during 8 sessions to anxiogenous environments without control. Imagery with functional MRI initial. Imagery with functional MRI final. Imagery with PET-scanner initial. Imagery with PET-scanner final. |
| Exposure with control | Experimental | Behavioral: Exposure to anxiogenous environments, Other: Imagery with functional MRI initial, Other: Imagery with PET-scanner initial, Other: Imagery with functional MRI final, Other: Imagery with PET-scanner finalExposure to anxiogenous environments: 20 acrophobic patients will be exposed during 8 sessions to anxiogenous environments with the ability to control and secure these. Imagery with functional MRI initial. Imagery with functional MRI final. Imagery with PET-scanner initial. Imagery with PET-scanner final. |
| Healthy volunteers | Other | Other: Imagery with functional MRI initial, Other: Imagery with PET-scanner initial20 healthy volunteers will be submitted to the same initial measurements in order to explore potential differences between them and the patients. Imagery with functional MRI initial. Imagery with PET-scanner initial. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18 to 60 years old
- Male or female
- All subjects will be fluent in French.
- Fully informed and freely given, signed Informed consent in written form.
- Patient / Subject affiliated or beneficiary of a social/health security insurance.
Key exclusion criteria (17 listed)
- Pregnant woman (urine and blood β -HCG test) or lactating (contraindication to PET-scan).
- Women of childbearing potential without effective contraception (contraindication to PET-scan).
- Subject participating in another research evaluating other treatments including a period of exclusion still ongoing.
- Persons under guardianship and adults subject submitted to a measure of legal protection or unable to consent.
- Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent under Articles L. 3212-1 and L. 3213-1 that do not fall under the provisions of Article L. 1121-8 and admitted to a health or social institution for purposes other than research.
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 |
|---|---|---|
| Exposure to anxiogenous environmentsThe anxiogenous environments are defined by several levels of possible anxiety classified progressively and independently by each patient at the beginning of the study. The exposure is applied during the 8 sessions for each of the arms "Exposure to anxiogenous environments (with or without control)". | Behavioural | Exposure with control, Exposure without control |
| Imagery with functional MRI initialSubjects will be submitted to 1 session of fMRI during their first visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments. | Other | Exposure with control, Exposure without control, Healthy volunteers |
| Imagery with PET-scanner initialSubjects will be submitted to 1 session of PET-scanner during their first visit, in order to measure the synaptic activity during the exposure to anxiogenous environments. | Other | Exposure with control, Exposure without control, Healthy volunteers |
| Imagery with functional MRI finalPatients will be submitted to 1 session of fMRI during a follow-up visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments. | Other | Exposure with control, Exposure without control |
| Imagery with PET-scanner finalPatients will be submitted to 1 session of PET-scanner during a follow-up visit, in order to measure the synaptic activity during the exposure to anxiogenous environments. | Other | Exposure with control, Exposure without control |
Primary outcome
Behavioural Avoidance Test (BAT)
Time frame: 1 year (4 times)
Objective measure of behavior scored on 10 points in response to a virtual environment representing a situation feared by acrophobic patients. This virtual environment is a flat landscape with a platform overlooking a canyon of 800 meters.
14 secondary outcomes
Brain activity (functional MRI)
Time frame: 12 weeks (2 times)
Synaptic activity (PET-scan)
Time frame: 12 weeks (2 times)
Cognitive measurements
Time frame: 12 weeks (2 times)
Cognitive measurements
Time frame: 12 weeks (2 times)
Cognitive measurements
Time frame: 1 year (4 times)
Cognitive measurements
Time frame: 1 year (4 times)
Cognitive measurements
Time frame: 1 year (4 times)
Cognitive measurements
Time frame: 1 year (4 times)
Quality of life
Time frame: 1 year (4 times)
Cognitive measurements
Time frame: 10 weeks (8 times)
Cognitive measurements
Time frame: 10 weeks (8 times)
Ergonomy
Time frame: 10 weeks (8 times)
Psychophysiological
Time frame: 10 weeks (8 times)
Adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
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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.
Eric MALBOS, MD principal investigator
Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille
Daniel MESTRE, PhD study chair
DR2, UMR 6233 CNRS; Université de la Méditerranée; CRVM
Stéphanie KHALFA, PhD study director
CR1, Institut des Neurosciences Timone, Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to anxiogenous environments, Imagery with functional MRI initial and Imagery with PET-scanner initial in people with Phobic Disorders, run by Qualissima 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 10 inclusion and 17 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 30 Oct 2015. 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?
Contact Eric MALBOS, MD (0491746287 ext. +33, eric.malbos@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioural Avoidance Test (BAT) (time frame: 1 year (4 times)). 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 2015.