Virtual Reality and Concept of Control in the Treatment of Acrophobia
NCT ID: NCT02020824
Last Updated: 2015-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2014-04-30
2017-07-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exposure without control
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.
Exposure to anxiogenous environments
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 initial
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 initial
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 final
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 final
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.
Exposure with control
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.
Exposure to anxiogenous environments
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 initial
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 initial
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 final
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 final
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.
Healthy volunteers
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.
Imagery with functional MRI initial
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 initial
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.
Interventions
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Exposure to anxiogenous environments
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 initial
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 initial
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 final
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 final
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.
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
Exclusion Criteria
* 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).
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Centre National de la Recherche Scientifique, France
OTHER
Qualissima
OTHER
Responsible Party
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Principal Investigators
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Eric MALBOS, MD
Role: PRINCIPAL_INVESTIGATOR
Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille
Daniel MESTRE, PhD
Role: STUDY_CHAIR
DR2, UMR 6233 CNRS; Université de la Méditerranée; CRVM
Stéphanie KHALFA, PhD
Role: STUDY_DIRECTOR
CR1, Institut des Neurosciences Timone, Marseille
Locations
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Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Eric MALBOS, MD
Role: primary
Other Identifiers
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2013-A01280-45 ID-RCB
Identifier Type: OTHER
Identifier Source: secondary_id
CTRLSTRESS
Identifier Type: -
Identifier Source: org_study_id