Phobic Disorders
Conditions
Keywords
Acrophobia
Brief 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. 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.
Interventions
BEHAVIORALExposure 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).
OTHERImagery 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.
OTHERImagery 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.
OTHERImagery 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.
OTHERImagery 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.
Sponsors
Centre National de la Recherche Scientifique, France
Qualissima
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
of all subjects: * 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. Inclusion criteria for acrophobic patients: * 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 Inclusion criteria for healthy volunteers: * People not hospitalized showing no sign of acrophobia. * Score superior or equal to 10 at the Behavioural Avoidance Test.
Exclusion criteria
for all subjects: * 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioural Avoidance Test (BAT) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain activity (functional MRI) | 12 weeks (2 times) | Anatomical and functional : brain activity in several cortical and subcortical areas with fMRI (BOLD signal intensity) |
| Synaptic activity (PET-scan) | 12 weeks (2 times) | Metabolic and functional : synaptic activity with PET scanner |
| Cognitive measurements | 12 weeks (2 times) | Attentional bias (DOT test) |
| Quality of life | 1 year (4 times) | Quality of Life (SF-12: Medical Outcome Study Short Form) |
| Psychophysiological | 10 weeks (8 times) | During the 8 sessions of exposure to virtual reality: Psychophysiological objective measurements during exposure to virtual reality (electrodermal activity, electrocardiography, breathing rate) |
| Adverse events | 1 year | Assessment and description of all the occurrence of adverse events during the study. |
| Ergonomy | 10 weeks (8 times) | During the 8 sessions of exposure to virtual reality: Questionnaire on the applicability / realism / ergonomy (PQ: Questionnaire on the state of Presence). |
Countries
France
Contacts
Primary ContactEric MALBOS, MD
Backup ContactEric GUEDJ, MD, PD
Outcome results
None listed