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NCT02571790: Relax-TAG

Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation

Completed NA Last updated 26 May 2023
What this trial tests

NA trial testing Relaxation optimized virtual reality in Generalized Anxiety Disorders in 58 participants. Completed in 25 May 2023.

Timeline
13 October 2015
Primary endpoint
3 October 2017
25 May 2023

Quick facts

Lead sponsorAssistance Publique Hopitaux De Marseille
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment58
Start date13 October 2015
Primary completion3 October 2017
Estimated completion25 May 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

Adults 18 to 65, any sex, with Generalized Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorder: A Randomized Comparative Study with Standard Intervention.
    Malbos E, Chichery N, Borwell B, Weindel G, et al · · 2025 · cited 2× · PMID 40004880 · DOI 10.3390/jcm14041351

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Data sources for this page

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