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CompletedNCT02571790Relax-TAGUpdated May 26, 2023

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

An interventional study of Relaxation optimized virtual reality and Classical relaxation (without Virtual Reality) in Generalized Anxiety Disorders, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-05-26.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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
02

Conditions studied

  • Generalized Anxiety Disorders

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Keywords

  • Patient with Generalized Anxiety Disorders
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 58 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • 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)

Interventions

  • BehavioralRelaxation optimized virtual reality
  • BehavioralClassical relaxation (without Virtual Reality)
06

What researchers measure

Primary outcomes

  1. scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG)

    Penn State Worry Questionnaire

    Time frame: 24 months

Secondary outcomes

  1. Short self-completion questionnaire on the Generalized Anxiety Disorders (TAG)

    Time frame: 24 months

07

Study locations

1 site
  • Assistance Publique Hôpitaux de Marseille
    Marseille, 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02571790
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Oct 8, 2015
Start date
Oct 13, 2015
Primary completion
Oct 3, 2017
Completion
May 25, 2023
Last update
May 26, 2023

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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