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

Primary Purpose

Generalized Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Relaxation optimized virtual reality
Classical relaxation (without Virtual Reality)
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Generalized Anxiety Disorders focused on measuring Patient with Generalized Anxiety Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Relaxation optimized virtual reality

Classical relaxation (without Virtual Reality).

Arm Description

six relaxation sessions with virtual reality

six relaxation sessions without virtual reality

Outcomes

Primary Outcome Measures

scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG)
Penn State Worry Questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2015
Last Updated
May 25, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02571790
Brief Title
Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
Acronym
Relax-TAG
Official Title
Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2015 (Actual)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorders
Keywords
Patient with Generalized Anxiety Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation optimized virtual reality
Arm Type
Experimental
Arm Description
six relaxation sessions with virtual reality
Arm Title
Classical relaxation (without Virtual Reality).
Arm Type
Experimental
Arm Description
six relaxation sessions without virtual reality
Intervention Type
Behavioral
Intervention Name(s)
Relaxation optimized virtual reality
Intervention Type
Behavioral
Intervention Name(s)
Classical relaxation (without Virtual Reality)
Primary Outcome Measure Information:
Title
scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG)
Description
Penn State Worry Questionnaire
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Short self-completion questionnaire on the Generalized Anxiety Disorders (TAG)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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