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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG) [ Time Frame: 24 months ]Penn State Worry Questionnaire
- Short self-completion questionnaire on the Generalized Anxiety Disorders (TAG) [ Time Frame: 24 months ]
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
|Contact: Urielle DESALBRES, Directorfirstname.lastname@example.org|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Urielle DESALBRES, Director 0491382747 email@example.com|
|Principal Investigator: Eric MALBOS, PhD|