CTRLSTRESS: Virtual Reality and Concept of Control in the Treatment of Acrophobia

Sponsor

Qualissima (Other)

Overall Status

Unknown status

CT.gov ID

NCT02020824

Collaborator

Centre National de la Recherche Scientifique, France (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Phobic Disorders	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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Virtual Reality and Concept of Control in the Treatment of Acrophobia by Exposure to Virtual Environments: Comparative Test

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: 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)". Other: 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. Other: 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. Other: 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. Other: 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.
Experimental: 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.	Behavioral: 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)". Other: 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. Other: 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. Other: 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. Other: 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.
Other: 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.	Other: 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. Other: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: 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)".

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Experimental: 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.

Behavioral: Exposure to anxiogenous environments

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)
Cognitive measurements [12 weeks (2 times)]
Emotional valence (emotional congruence task)
Cognitive measurements [1 year (4 times)]
Questionnaire on acrophobia (AQ: Acrophobia Questionnaire)
Cognitive measurements [1 year (4 times)]
Questionnaire on acrophobia (ATHQ: Attitude Towards Heights Questionnaire)
Cognitive measurements [1 year (4 times)]
Questionnaire on anxiety (STAI: Spielberger Trait Anxiety Inventory)
Cognitive measurements [1 year (4 times)]
Questionnaire on depression (BDI: Beck Depression Inventory)
Quality of life [1 year (4 times)]
Quality of Life (SF-12: Medical Outcome Study Short Form)
Cognitive measurements [10 weeks (8 times)]
During the 8 sessions of exposure to virtual reality: Questionnaires on anxiety (SUD: Subjective Unit of Discomfort)
Cognitive measurements [10 weeks (8 times)]
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 ..)
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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Exclusion criteria for acrophobic patients:

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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille	Marseille		France	13005

Sponsors and Collaborators

Qualissima
Centre National de la Recherche Scientifique, France

Investigators

Principal Investigator: Eric MALBOS, MD, Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille
Study Chair: Daniel MESTRE, PhD, DR2, UMR 6233 CNRS; Université de la Méditerranée; CRVM
Study Director: Stéphanie KHALFA, PhD, CR1, Institut des Neurosciences Timone, Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qualissima

ClinicalTrials.gov Identifier:

NCT02020824

Other Study ID Numbers:

CTRLSTRESS
2013-A01280-45 ID-RCB

First Posted:

Dec 25, 2013

Last Update Posted:

Oct 30, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Qualissima

Acrophobia

Additional relevant MeSH terms:

Phobic Disorders

Study Results

No Results Posted as of Oct 30, 2015