Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01280-45 ID-RCB | Other Identifier | ANSM - France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre National de la Recherche Scientifique, France | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure to anxiogenous environments | Behavioral | 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)". |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year (4 times) |
| Measure | Description | Time Frame |
|---|---|---|
| Brain activity (functional MRI) | Anatomical and functional : brain activity in several cortical and subcortical areas with fMRI (BOLD signal intensity) | 12 weeks (2 times) |
| Synaptic activity (PET-scan) |
Not provided
Inclusion Criteria of all subjects:
Inclusion criteria for acrophobic patients:
Inclusion criteria for healthy volunteers:
Exclusion Criteria for all subjects:
Exclusion criteria for acrophobic patients:
Exclusion criteria for healthy volunteers:
- 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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric MALBOS, MD | Contact | 0491746287 | +33 | eric.malbos@ap-hm.fr |
| Eric GUEDJ, MD, PD | Contact | 0491385558 | +33 | eric.guedj@univ-amu.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eric MALBOS, MD | Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille | Principal Investigator |
| Daniel MESTRE, PhD | DR2, UMR 6233 CNRS; Université de la Méditerranée; CRVM |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille | Recruiting | Marseille | 13005 | France |
Not provided
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| C000719188 | Acrophobia |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Imagery with functional MRI initial | Other | 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 | Other | 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 | Other | 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 | Other | 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. |
|
Metabolic and functional : synaptic activity with PET scanner
| 12 weeks (2 times) |
| Cognitive measurements | Attentional bias (DOT test) | 12 weeks (2 times) |
| Cognitive measurements | Emotional valence (emotional congruence task) | 12 weeks (2 times) |
| Cognitive measurements | Questionnaire on acrophobia (AQ: Acrophobia Questionnaire) | 1 year (4 times) |
| Cognitive measurements | Questionnaire on acrophobia (ATHQ: Attitude Towards Heights Questionnaire) | 1 year (4 times) |
| Cognitive measurements | Questionnaire on anxiety (STAI: Spielberger Trait Anxiety Inventory) | 1 year (4 times) |
| Cognitive measurements | Questionnaire on depression (BDI: Beck Depression Inventory) | 1 year (4 times) |
| Quality of life | Quality of Life (SF-12: Medical Outcome Study Short Form) | 1 year (4 times) |
| Cognitive measurements | During the 8 sessions of exposure to virtual reality: Questionnaires on anxiety (SUD: Subjective Unit of Discomfort) | 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 ..) | 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). | 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) | 10 weeks (8 times) |
| Adverse events | Assessment and description of all the occurrence of adverse events during the study. | 1 year |
| Stéphanie KHALFA, PhD | CR1, Institut des Neurosciences Timone, Marseille | Study Director |