Generalized Anxiety DisordersRelax-TAGNCT02571790
Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
A study testing Relaxation optimized virtual reality and Classical relaxation (without Virtual Reality) in people with Generalized Anxiety Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorders
- What is being tested?
- Relaxation optimized virtual reality and Classical relaxation (without Virtual Reality)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2015to 25 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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):
Read more
- 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
- Conditions
- Generalized Anxiety Disorders
- Being tested
- Relaxation optimized virtual reality, Classical relaxation (without Virtual Reality)
- Keywords
- Patient with Generalized Anxiety Disorders
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation optimized virtual realityBehavioural
Classical relaxation (without Virtual Reality)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Relaxation optimized virtual reality | Experimental | six relaxation sessions with virtual reality Receives: Behavioral: Relaxation optimized virtual reality |
| Classical relaxation (without Virtual Reality). | Experimental | six relaxation sessions without virtual reality Receives: Behavioral: Classical relaxation (without Virtual Reality) |
What is being measured
The primary outcome is the main question the study is designed to answer.
scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG)
Penn State Worry Questionnaire
Measured: 24 months
Secondary outcomes (1)
Short self-completion questionnaire on the Generalized Anxiety Disorders (TAG)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study start13 Oct 2015
- Primary completion3 Oct 2017
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571790
- Sponsor's protocol ID
- 2015-23
- Acronym
- Relax-TAG
- Status last verified
- May 2023
- First submitted
- 7 Oct 2015
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation
- ClinicalTrials.gov ID
- NCT02571790
- Acronym / sponsor ID
- Relax-TAG / 2015-23
- Conditions
- Generalized Anxiety Disorders
- Keywords
- Patient with Generalized Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 13 Oct 2015 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relaxation optimized virtual reality | Experimental | Behavioral: Relaxation optimized virtual realitysix relaxation sessions with virtual reality |
| Classical relaxation (without Virtual Reality). | Experimental | Behavioral: Classical relaxation (without Virtual Reality)six relaxation sessions without virtual reality |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation optimized virtual reality | Behavioural | Relaxation optimized virtual reality |
| Classical relaxation (without Virtual Reality) | Behavioural | Classical relaxation (without Virtual Reality). |
Primary outcome
scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG)
Time frame: 24 months
Penn State Worry Questionnaire
1 secondary outcome
Short self-completion questionnaire on the Generalized Anxiety Disorders (TAG)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation optimized virtual reality and Classical relaxation (without Virtual Reality) in people with Generalized Anxiety Disorders, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scores on psychometric scales in connection with the Generalized Anxiety Disorders (TAG) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.