Virtual Reality and Concept of Control in the Treatment of Acrophobia

NCT02020824 | Unknown

• 2 other identifiers: CTRLSTRESS2013-A01280-45 ID-RCB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobic Disorders

Keywords

Acrophobia

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (14)

• Brain activity (functional MRI)

  12 weeks (2 times)

• Synaptic activity (PET-scan)

  12 weeks (2 times)

• Cognitive measurements

  12 weeks (2 times)

• Cognitive measurements

  12 weeks (2 times)

• Cognitive measurements

  1 year (4 times)

Study Arms (3)

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.

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

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.

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

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.

Other: Imagery with functional MRI initial; Other: Imagery with PET-scanner initial

Interventions

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)".

Exposure with control; Exposure without control

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.

Exposure with control; Exposure without control; Healthy volunteers

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.

Exposure with control; Exposure without control; Healthy volunteers

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.

Exposure with control; Exposure without control

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.

Exposure with control; Exposure without control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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
• People not hospitalized showing no sign of acrophobia.
• Score superior or equal to 10 at the Behavioural Avoidance Test.

You may not qualify if:

• 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).
• 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.
• 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.
• No psychotherapy should be initiated during the study.
• \- 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.

Sponsors & Collaborators

• Qualissima: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Phobic Disorders; Acrophobia

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• 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

  STUDY CHAIR

• Stéphanie KHALFA, PhD

  CR1, Institut des Neurosciences Timone, Marseille

  STUDY DIRECTOR

Central Study Contacts

Eric MALBOS, MD

CONTACT

0491746287; eric.malbos@ap-hm.fr

Eric GUEDJ, MD, PD

CONTACT

0491385558; eric.guedj@univ-amu.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: April 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 30, 2015

Record last verified: 2015-10

Locations

FR (1)