Trial record 17 of 49 for:    Open Studies | "Phobic Disorders"

Virtual Reality and Concept of Control in the Treatment of Acrophobia (CTRLSTRESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Qualissima
Sponsor:
Collaborator:
France: Centre National de la Recherche Scientifique
Information provided by (Responsible Party):
Qualissima
ClinicalTrials.gov Identifier:
NCT02020824
First received: December 19, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention
Phobic Disorders
Behavioral: Exposure to neutral environments
Behavioral: Exposure to anxiogenous environments
Other: Imagery with functional MRI
Other: Imagery with PET-scanner

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Qualissima:

Primary Outcome Measures:
  • Behavioural Avoidance Test (BAT) [ Time Frame: 1 year (4 times) ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks (2 times) ] [ Designated as safety issue: No ]
    Anatomical and functional : brain activity in several cortical and subcortical areas with fMRI (BOLD signal intensity)

  • Synaptic activity (PET-scan) [ Time Frame: 12 weeks (2 times) ] [ Designated as safety issue: No ]
    Metabolic and functional : synaptic activity with PET scanner

  • Cognitive measurements [ Time Frame: 12 weeks (2 times) ] [ Designated as safety issue: No ]
    Attentional bias (DOT test)

  • Cognitive measurements [ Time Frame: 12 weeks (2 times) ] [ Designated as safety issue: No ]
    Emotional valence (emotional congruence task)

  • Cognitive measurements [ Time Frame: 1 year (4 times) ] [ Designated as safety issue: No ]
    Questionnaire on acrophobia (AQ: Acrophobia Questionnaire)

  • Cognitive measurements [ Time Frame: 1 year (4 times) ] [ Designated as safety issue: No ]
    Questionnaire on acrophobia (ATHQ: Attitude Towards Heights Questionnaire)

  • Cognitive measurements [ Time Frame: 1 year (4 times) ] [ Designated as safety issue: No ]
    Questionnaire on anxiety (STAI: Spielberger Trait Anxiety Inventory)

  • Cognitive measurements [ Time Frame: 1 year (4 times) ] [ Designated as safety issue: No ]
    Questionnaire on depression (BDI: Beck Depression Inventory)

  • Quality of life [ Time Frame: 1 year (4 times) ] [ Designated as safety issue: No ]
    Quality of Life (SF-12: Medical Outcome Study Short Form)

  • Cognitive measurements [ Time Frame: 10 weeks (8 times) ] [ Designated as safety issue: No ]
    During the 8 sessions of exposure to virtual reality: Questionnaires on anxiety (SUD: Subjective Unit of Discomfort)

  • Cognitive measurements [ Time Frame: 10 weeks (8 times) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 weeks (8 times) ] [ Designated as safety issue: No ]
    During the 8 sessions of exposure to virtual reality: Questionnaire on the applicability / realism / ergonomy (PQ: Questionnaire on the state of Presence).

  • Psychophysiological [ Time Frame: 10 weeks (8 times) ] [ Designated as safety issue: No ]
    During the 8 sessions of exposure to virtual reality: Psychophysiological objective measurements during exposure to virtual reality (electrodermal activity, electrocardiography, breathing rate)

  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Assessment and description of all the occurrence of adverse events during the study.


Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Exposure to neutral environments
Exposure to neutral environments: 20 acrophobic patients will be exposed during 8 sessions to neutral environments.
Behavioral: Exposure to neutral environments
The neutral environment is defined by an environment without anxiogenous event or situation. The exposure is applied as a training during the first session for each arm. It is prolonged until 8 sessions for the arm "Exposure to neutral environments".
Other: Imagery with functional MRI
Subjects will be submitted to 2 sessions of fMRI, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
Other: Imagery with PET-scanner
Subjects will be submitted to 2 sessions of PET-scanner, in order to measure the synaptic activity during the exposure to anxiogenous environments.
Active Comparator: Exposure without control
Exposure to anxiogenous environments: 20 acrophobic patients will be exposed during 8 sessions to anxiogenous environments without control.
Behavioral: Exposure to neutral environments
The neutral environment is defined by an environment without anxiogenous event or situation. The exposure is applied as a training during the first session for each arm. It is prolonged until 8 sessions for the arm "Exposure to neutral environments".
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
Subjects will be submitted to 2 sessions of fMRI, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
Other: Imagery with PET-scanner
Subjects will be submitted to 2 sessions of PET-scanner, 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.
Behavioral: Exposure to neutral environments
The neutral environment is defined by an environment without anxiogenous event or situation. The exposure is applied as a training during the first session for each arm. It is prolonged until 8 sessions for the arm "Exposure to neutral environments".
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
Subjects will be submitted to 2 sessions of fMRI, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
Other: Imagery with PET-scanner
Subjects will be submitted to 2 sessions of PET-scanner, 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 and final measurements in order to assess the effect of test and retest (especially for imagery with fMRI and PET-scan, but also for BAT and cognitive measurements).

Imagery with functional MRI.

Imagery with PET-scanner.

Other: Imagery with functional MRI
Subjects will be submitted to 2 sessions of fMRI, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
Other: Imagery with PET-scanner
Subjects will be submitted to 2 sessions of PET-scanner, in order to measure the synaptic activity during the exposure to anxiogenous environments.

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: simple exposure to virtual environment, 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020824

Contacts
Contact: Eric MALBOS, MD 0491746287 ext +33 eric.malbos@ap-hm.fr
Contact: Eric GUEDJ, MD, PD 0491385558 ext +33 eric.guedj@univ-amu.fr

Locations
France
Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille Recruiting
Marseille, France, 13274
Contact: Eric MALBOS, MD    0491746287 ext +33    eric.malbos@ap-hm.fr   
Principal Investigator: Eric MALBOS, MD         
Sponsors and Collaborators
Qualissima
France: Centre National de la Recherche Scientifique
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
  More Information

No publications provided

Responsible Party: Qualissima
ClinicalTrials.gov Identifier: NCT02020824     History of Changes
Other Study ID Numbers: CTRLSTRESS, 2013-A01280-45 ID-RCB
Study First Received: December 19, 2013
Last Updated: May 19, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Qualissima:
Acrophobia

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014