Informations générales (source: ClinicalTrials.gov)
Virtual Reality and Concept of Control in the Treatment of Acrophobia by Exposure to Virtual Environments: Comparative Test (CTRLSTRESS)
Interventional
N/A
Qualissima (Voir sur ClinicalTrials)
avril 2014
juillet 2017
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service hospitalo-universitaire de psychologie médicale de psychiatrie d'adultes du Pr Lançon - CHU Marseille - 13005 - Marseille - France | Eric MALBOS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.