Back to resultsVirtual Reality and Concept of Control in the Treatment of Acrophobia (CTRLSTRESS)
Primary Purpose
Phobic Disorders
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exposure to anxiogenous environments
Imagery with functional MRI initial
Imagery with PET-scanner initial
Imagery with functional MRI final
Imagery with PET-scanner final
Sponsored by
About this trial
This is an interventional treatment trial for Phobic Disorders focused on measuring Acrophobia
Eligibility Criteria
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.
Sites / Locations
- Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
Exposure without control
Exposure with control
Healthy volunteers
Arm Description
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: 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Brain activity (functional MRI)
Anatomical and functional : brain activity in several cortical and subcortical areas with fMRI (BOLD signal intensity)
Synaptic activity (PET-scan)
Metabolic and functional : synaptic activity with PET scanner
Cognitive measurements
Attentional bias (DOT test)
Cognitive measurements
Emotional valence (emotional congruence task)
Cognitive measurements
Questionnaire on acrophobia (AQ: Acrophobia Questionnaire)
Cognitive measurements
Questionnaire on acrophobia (ATHQ: Attitude Towards Heights Questionnaire)
Cognitive measurements
Questionnaire on anxiety (STAI: Spielberger Trait Anxiety Inventory)
Cognitive measurements
Questionnaire on depression (BDI: Beck Depression Inventory)
Quality of life
Quality of Life (SF-12: Medical Outcome Study Short Form)
Cognitive measurements
During the 8 sessions of exposure to virtual reality: Questionnaires on anxiety (SUD: Subjective Unit of Discomfort)
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 ..)
Ergonomy
During the 8 sessions of exposure to virtual reality: Questionnaire on the applicability / realism / ergonomy (PQ: Questionnaire on the state of Presence).
Psychophysiological
During the 8 sessions of exposure to virtual reality: Psychophysiological objective measurements during exposure to virtual reality (electrodermal activity, electrocardiography, breathing rate)
Adverse events
Assessment and description of all the occurrence of adverse events during the study.
Full Information
NCT ID
NCT02020824
First Posted
December 19, 2013
Last Updated
October 29, 2015
Sponsor
Qualissima
Collaborators
Centre National de la Recherche Scientifique, France
1. Study Identification
Unique Protocol Identification Number
NCT02020824
Brief Title
Virtual Reality and Concept of Control in the Treatment of Acrophobia
Acronym
CTRLSTRESS
Official Title
Virtual Reality and Concept of Control in the Treatment of Acrophobia by Exposure to Virtual Environments: Comparative Test
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qualissima
Collaborators
Centre National de la Recherche Scientifique, France
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobic Disorders
Keywords
Acrophobia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exposure without control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exposure with control
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure to anxiogenous environments
Intervention Description
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)".
Intervention Type
Other
Intervention Name(s)
Imagery with functional MRI initial
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Imagery with PET-scanner initial
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Imagery with functional MRI final
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Imagery with PET-scanner final
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavioural Avoidance Test (BAT)
Description
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.
Time Frame
1 year (4 times)
Secondary Outcome Measure Information:
Title
Brain activity (functional MRI)
Description
Anatomical and functional : brain activity in several cortical and subcortical areas with fMRI (BOLD signal intensity)
Time Frame
12 weeks (2 times)
Title
Synaptic activity (PET-scan)
Description
Metabolic and functional : synaptic activity with PET scanner
Time Frame
12 weeks (2 times)
Title
Cognitive measurements
Description
Attentional bias (DOT test)
Time Frame
12 weeks (2 times)
Title
Cognitive measurements
Description
Emotional valence (emotional congruence task)
Time Frame
12 weeks (2 times)
Title
Cognitive measurements
Description
Questionnaire on acrophobia (AQ: Acrophobia Questionnaire)
Time Frame
1 year (4 times)
Title
Cognitive measurements
Description
Questionnaire on acrophobia (ATHQ: Attitude Towards Heights Questionnaire)
Time Frame
1 year (4 times)
Title
Cognitive measurements
Description
Questionnaire on anxiety (STAI: Spielberger Trait Anxiety Inventory)
Time Frame
1 year (4 times)
Title
Cognitive measurements
Description
Questionnaire on depression (BDI: Beck Depression Inventory)
Time Frame
1 year (4 times)
Title
Quality of life
Description
Quality of Life (SF-12: Medical Outcome Study Short Form)
Time Frame
1 year (4 times)
Title
Cognitive measurements
Description
During the 8 sessions of exposure to virtual reality: Questionnaires on anxiety (SUD: Subjective Unit of Discomfort)
Time Frame
10 weeks (8 times)
Title
Cognitive measurements
Description
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 ..)
Time Frame
10 weeks (8 times)
Title
Ergonomy
Description
During the 8 sessions of exposure to virtual reality: Questionnaire on the applicability / realism / ergonomy (PQ: Questionnaire on the state of Presence).
Time Frame
10 weeks (8 times)
Title
Psychophysiological
Description
During the 8 sessions of exposure to virtual reality: Psychophysiological objective measurements during exposure to virtual reality (electrodermal activity, electrocardiography, breathing rate)
Time Frame
10 weeks (8 times)
Title
Adverse events
Description
Assessment and description of all the occurrence of adverse events during the study.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric MALBOS, MD
Phone
0491746287
Ext
+33
Email
eric.malbos@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Eric GUEDJ, MD, PD
Phone
0491385558
Ext
+33
Email
eric.guedj@univ-amu.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric MALBOS, MD
Organizational Affiliation
Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel MESTRE, PhD
Organizational Affiliation
DR2, UMR 6233 CNRS; Université de la Méditerranée; CRVM
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stéphanie KHALFA, PhD
Organizational Affiliation
CR1, Institut des Neurosciences Timone, Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric MALBOS, MD
Phone
0491435552
Ext
+33
Email
eric.malbos@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Eric MALBOS, MD
12. IPD Sharing Statement
Learn more about this trial
Virtual Reality and Concept of Control in the Treatment of Acrophobia
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