Clinical trial NCT02571790: Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
Official title: Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorders
Keywords: Patient with Generalized Anxiety Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise of quality of life when using methods of relaxation combined with virtual reality with patients suffering from generalized anxiety disorder in comparison of the effect of traditional relaxation therapy. Observe and evaluate the effect of perceived presence in synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of generalized anxiety disorder.

It is a comparative, randomized, two groups study (29 in each group):

* Relaxation optimized virtual reality
* Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7 relaxing sessions (with or without virtual reality epending on the group). Each session lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive trials, in order to avoid cyber sickness in the virtual reality group.

Expected results: a measurable therapeutic improvement produced by the combination of relaxation and virtual and its additional effect when compared to the traditional treatment.

Measurements of variables and therapeutic effects will be carried out with psychometric measures.

The creation process of the relaxing virtual environments has already been completed. The virtual environments are ready for use.

The apparatus needed and in our possession include:

* A laptop for generating virtual environments
* A stereoscopic display
* Apparatus for physiological measurements


Eligibility criteria: Inclusion Criteria:

* Male or Female.
* Age 18-65 years inclusive.
* Generalized Anxiety Disorders primary diagnosis in patients according with major depressive episode V (DSM-V) criteria.
* Topic speaking English or French language
* Subject who have signed a written informed consent and undertaking to comply with the instructions of the protocol.

Exclusion Criteria:

* Subject not having at least one inclusion criterion;
* Minor Subject, pregnant or nursing women, about not being affiliated to the social security scheme, or deprived of liberty subject;
* Age greater than 18 and less than 65 years.
* Subject Trust;
* Subject indication against having a virtual reality: epilepsy, major organ failure, severe myopia, acute psychiatric disorder (such as schizophrenia in acute period, paranoia, manic, or melancholic major depression).
* Subject did not sign the informed consent, or topic for which the legal representative has not signed this consent in cases where the subject is under curatorship.
* Subject wishing to interrupt his participation in the study before the end;
* Subject for which the occurrence of an event makes it necessary to interrupt the therapy program before the end
* History of neurological disease, head injury or mental retardation.
* Presence of a psychotic disorder decompensated
* Presence of addictologique comorbidity.

Primary outcomes:
measure: scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG)
timeFrame: 24 months
Secondary outcomes:
measure: Short self-completion questionnaire on the Generalized Anxiety Disorders (TAG)
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References: