AnorexiaREVAMNCT03118921
Body Image Disorder in Anorexia Nervosa and Virtual Reality
A study testing Virtual reality in people with Anorexia, run by University Hospital, Brest at 1 site in France.
Trial summary
Evaluation of the tolerance and acceptability of the virtual representation of its body image. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Anorexia
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2017to 31 Oct 2019
- 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 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women, aged between 16 and 40
- Post-puberty
- Pure restrictive anorexia nervosa, diagnosis by the DSM-V
- BMI <17.5
- Patient attending an outpatient clinic at the Bohars Psychiatric Hospital in France
- Having signed the Informed Consent Form
- For minor patients, signing the form of informed consent of both parents
Who cannot join
- Associated eating disorder (bulimia, or the binge eating / purging form of anorexia nervosa),
- Psychiatric disorders (characterized depressed, anxiety disorder)
- Neurological Disorders
- Mental retardation
- Abuse or addiction to alcohol
- Abuse or dependence on psychoactive substances in the previous year.
- Patient with a protective justice measure
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the tolerance and acceptability of the virtual representation of its body image.
- Conditions
- Anorexia
- Being tested
- Virtual reality
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-questionnaire assessing tolerance
Patients will have to respond to a self-administered questionnaire assessing tolerance
Measured: Day 15
Self-questionnaire assessing acceptability
Patients will have to respond to a self-administered questionnaire assessing acceptability
Measured: Day 15
Secondary outcomes (3)
Feeling of presence
Patients will respond to a self-questionnaire of feeling of presence
Measured: Day 15
Subjective experience by EDI-2 questionnaire
Pre- and post-test comparison of body dissatisfaction by EDI-2 questionnaire.
Measured: Day 15
Subjective experience by BSQ questionnaire
Pre- and post-test comparison of body dissatisfaction by BSQ questionnaire.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start20 Apr 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Why it stopped: suggestion of an accentuation of the bias of overestimating the silhouette in one of the avatar exposure modalities in virtual reality
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118921
- Sponsor's protocol ID
- REVAM
- Acronym
- REVAM
- Status last verified
- Dec 2021
- First submitted
- 3 Apr 2017
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Image Disorder in Anorexia Nervosa and Virtual Reality
- ClinicalTrials.gov ID
- NCT03118921
- Acronym / sponsor ID
- REVAM / REVAM
- Conditions
- Anorexia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: suggestion of an accentuation of the bias of overestimating the silhouette in one of the avatar exposure modalities in virtual reality
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
Evaluation of the tolerance and acceptability of the virtual representation of its body image.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual realityThe first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Women, aged between 16 and 40
- Post-puberty
- Pure restrictive anorexia nervosa, diagnosis by the DSM-V
- BMI <17.5
- Patient attending an outpatient clinic at the Bohars Psychiatric Hospital in France
Key exclusion criteria (7 listed)
- Associated eating disorder (bulimia, or the binge eating / purging form of anorexia nervosa),
- Psychiatric disorders (characterized depressed, anxiety disorder)
- Neurological Disorders
- Mental retardation
- Abuse or addiction to alcohol
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 |
|---|---|---|
| Virtual realityThe first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software. | Device | Virtual reality |
Primary outcome
Self-questionnaire assessing tolerance
Time frame: Day 15
Patients will have to respond to a self-administered questionnaire assessing tolerance
Self-questionnaire assessing acceptability
Time frame: Day 15
Patients will have to respond to a self-administered questionnaire assessing acceptability
3 secondary outcomes
Feeling of presence
Time frame: Day 15
Subjective experience by EDI-2 questionnaire
Time frame: Day 15
Subjective experience by BSQ questionnaire
Time frame: Day 15
Results and safety
The study was stopped early (reason given: suggestion of an accentuation of the bias of overestimating the silhouette in one of the avatar exposure modalities in virtual reality). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
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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 Virtual reality in people with Anorexia, run by University Hospital, Brest 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 28 Dec 2021. 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 was stopped early (reason given: suggestion of an accentuation of the bias of overestimating the silhouette in one of the avatar exposure modalities in virtual reality). Results are not available in the source record.
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?
Self-questionnaire assessing tolerance (time frame: Day 15). The study lists 2 primary outcomes in all. 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 28 Dec 2021.