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Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation (Relax-TAG)

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ClinicalTrials.gov Identifier: NCT02571790
Recruitment Status : Unknown
Verified October 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorders Behavioral: Relaxation optimized virtual reality Behavioral: Classical relaxation (without Virtual Reality) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Relaxation optimized virtual reality
six relaxation sessions with virtual reality
Behavioral: Relaxation optimized virtual reality
Experimental: Classical relaxation (without Virtual Reality).
six relaxation sessions without virtual reality
Behavioral: Classical relaxation (without Virtual Reality)



Primary Outcome Measures :
  1. scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG) [ Time Frame: 24 months ]
    Penn State Worry Questionnaire


Secondary Outcome Measures :
  1. Short self-completion questionnaire on the Generalized Anxiety Disorders (TAG) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571790


Contacts
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Contact: Urielle DESALBRES, Director 0491382747 drci@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Urielle DESALBRES, Director    0491382747    drci@ap-hm.fr   
Principal Investigator: Eric MALBOS, PhD         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02571790    
Other Study ID Numbers: 2015-23
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015
Keywords provided by Assistance Publique Hopitaux De Marseille:
Patient with Generalized Anxiety Disorders
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders