Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa (TERV-TCA)
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| ClinicalTrials.gov Identifier: NCT03426930 |
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Recruitment Status : Unknown
Verified February 2018 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
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Anorexia nervosa is an eating disorder that begins frequently in adolescence between the ages of 13 and 19, which affects girls with a sex ratio of 10:1, and the prevalence for females varies from 0,3% to 0,9%.
The current therapeutic arsenal has a limited success in the treatment of anorexia nervosa with a long-term mortality rate and a 12-month relapse rate of up to 10% and 40%, respectively.
One of the most difficult symptoms to treat is a body dysmorphic disorder, also called dysmorphophobia, the persistence of this symptom is a major negative prognostic factor.
The main treatment of dysmorphophobia is currently cognitive behavioral therapy (CBT). In most protocols, the technique of progressive exposure face to the mirror is used with low efficiency. Adapted physical activity has recently been proposed in the literature as a tool to improve body perception.
Face of complex management of this major symptom that is dysmorphophobia, some offer to use virtual reality.
It is in this context that the study proposes to study the contribution of virtual reality in the treatment of the body dysmorphic disorder of adolescent patients hospitalized for anorexia nervosa in the department of Child and Adolescent Psychiatry Salvator Hospital in Marseille.
It will be compare the importance and the evolution of the dysmorphophobia between two groups of teenagers hospitalized in Space Arthur for anorexia nervosa: an experimental group receiving the treatment with the contribution of the virtual reality, and a control group receiving the reference treatment of dysmorphophobia used in our unit.
It will be recruit 30 adolescent females with anorexia nervosa according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5. The subjects will be divided into 2 groups of 15 teenagers, according to a randomization list, a group with a classic protocol, a group with virtual reality. The subjects with virtual reality will have 5 exposure sessions where they will be able to model their body in view in 1st person and 3rd person, via an Oculus Rift. It will be compare the following parameters: the different scores related to dysmorphophobia according to different questionnaires, the self-evaluation of the Body Mass Index (BMI), in order to observe the evolution of the symptom, then the anxiety relative to the exposure of a BMI higher in order to work the fear of getting fat, the choice of the most pleasant BMI, to evaluate skinny body addiction.
At the end of the study, we hope to highlight the effectiveness of virtual reality to fight against dysmorphophobia, in order to have a better estimate of its body aspect, and to impact the evolution towards the cure in anorexia nervosa in teenage girls. In addition to increasing our knowledge, this could allow to consider new strategies in the management of anorexia nervosa, and why not democratize more virtual reality with adolescents followed in child and adolescent psychiatry.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anorexia Nervosa | Other: self-evaluation of the Body Mass Index Other: Cognitive-behavioral psychotherapies | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa |
| Actual Study Start Date : | January 17, 2018 |
| Estimated Primary Completion Date : | January 17, 2020 |
| Estimated Study Completion Date : | January 17, 2021 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: The reference treatment of dysmorphophobia used |
Other: self-evaluation of the Body Mass Index
Evaluation of the Body Mass Index before and after the treatment Other: Cognitive-behavioral psychotherapies Cognitive-behavioral psychotherapies before and after the treatment |
| Experimental: The reference treatment with the virtual reality |
Other: self-evaluation of the Body Mass Index
Evaluation of the Body Mass Index before and after the treatment Other: Cognitive-behavioral psychotherapies Cognitive-behavioral psychotherapies before and after the treatment |
- Evaluation of non-self Body Mass Index [ Time Frame: 24 months ]the self-evaluation of BMI will allow to observe the evolution of the symptom of dysmorphophobia. Explicit and implicit assessment of lean body addiction.
- Eating Disorder Inventory 2 (EDI) [ Time Frame: 24 months ]The EDI is intended to assess attitudes and behaviors related to eating behavior in 11 sub-scales. the most pathological answer are rated 0
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| Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 13 et 18 years old
- Female subject
- Females with anorexia nervosa according to the diagnostic criteria of DSM-5
- The patient, the parents or the legal representative (s) have given written consent
- Possessing a social security scheme
Exclusion Criteria:
- Male subject
- Age under 13 years or over 18 years
- Subject presenting a contra-indication to virtual reality
- Subject, or parents who refused to sign informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426930
| Contact: Flora BAT, PH | 491745850 ext +33 | flora.bat@ap-hm.fr | |
| Contact: Isabelle CHARVIN, Clinical Study Assistant | 491745850 ext +33 | isabelle.charvin@ap-hm.fr |
| France | |
| Assistance Publique Hôpitaux de Marseille | Recruiting |
| Marseille, France, 13354 | |
| Contact: Flora BAT, PH 491745860 ext +33 flora.bat@ap-hm.fr | |
| Principal Investigator: Flora BAT, PH | |
| Study Director: | Jean-Olivier ARNAUD, General Director | ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE |
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT03426930 |
| Other Study ID Numbers: |
2017-40 2017-A02836-47 ( Registry Identifier: ID RCB ) |
| First Posted: | February 8, 2018 Key Record Dates |
| Last Update Posted: | February 8, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Anorexia Anorexia Nervosa Signs and Symptoms, Digestive Feeding and Eating Disorders Mental Disorders |