Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa

NCT ID: NCT04107870

Last Updated: 2023-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-20

Study Completion Date

2028-09-20

Brief Summary

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Anorexia nervosa is defined in DSM V as a quantitative and qualitative dietary restriction resulting in significant weight loss, intense fear of weight gain, altered weight and body shape perception (body dysmorphic disorder) and low self-esteem influenced by weight or body shape. Body dysmorphic disorder is the most difficult symptom to manage in anorexia nervosa and its persistence is a factor associated with relapse.

Virtual reality exposure therapy has proven its effectiveness in the management of post-traumatic stress disorder in the military and is a widely used therapy. The effectiveness of this treatment using new technologies has not yet been studied for the treatment of body dysmorphic disorder in anorexia nervosa and is not used routinely. It could represent an interesting alternative to the physical approach in psychomotor therapy, traditionally offered to patients suffering from anorexia nervosa. It is important to evaluate the effectiveness of virtual reality exposure therapy in the management of body dysmorphic disorder in patients with anorexia nervosa by comparing these two care techniques.

Detailed Description

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The aim of this study is to evaluate the effectiveness of Virtual Reality Exposure Therapy in the management of body dysmorphic disorder in patients with anorexia nervosa, compared to the traditionally proposed body approach in psychomotor therapy.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Virtual Reality Exposure Therapy

Female adolescents aged 13 to 18 are proposed virtual reality exposure therapy sessions, accompanied by a cognitive and behavioral therapy (CBT) therapist, to work on their body representations

Group Type EXPERIMENTAL

Virtual Reality Exposure Therapy sessions

Intervention Type BEHAVIORAL

Female adolescents aged 13 to 18 are proposed virtual reality exposure therapy sessions, accompanied by a cognitive and behavioral therapy (CBT) therapist, to work on their body representations

Psychomotor Therapy

Psychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations.

Group Type ACTIVE_COMPARATOR

Psychomotor therapy sessions

Intervention Type BEHAVIORAL

Psychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations.

Interventions

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Virtual Reality Exposure Therapy sessions

Female adolescents aged 13 to 18 are proposed virtual reality exposure therapy sessions, accompanied by a cognitive and behavioral therapy (CBT) therapist, to work on their body representations

Intervention Type BEHAVIORAL

Psychomotor therapy sessions

Psychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female adolescents aged 13 to 18
* with a diagnosis of anorexia nervosa of all types (including purgative and hyperphagic) according to the DSM-V
* French as first language
* agreed to participate in the study
* parental authority holders accepting her participation in the study
* affiliated to a social security system

Patients will not be included in the study:

* with a somatic severity criterion:

* Total aphagia
* Body mass index (BMI) \< 14kg/m² for those over 17 years of age, BMI \< 13.2kg/m² for those aged 15-16 and BMI \< 12.7kg/m² for those aged 13-14.
* Confusion
* Bradycardia \<40/min, Tachycardia
* Blood pressure \< 80/50mmHg
* Hypothermia \<35.5°C
* Severe metabolic disorders: hypokalemia \< 2.5 mmol/l, hyponatremia \< 125mmol/l or hypernatremia \> 150 mmol/l, hypophosphoremia \< 0.5 mmol/l
* Acetonuria, hypoglycemia \< 0.6g/l
* Creatinine elevation \> 100micromol/l
* Cytolysis \> 4N
* Leuconeutropenia \<1000/mm3
* Thrombocytopenia \<6000000/mm3
* Suicide attempt in the last month before inclusion
* Receiving benzodiazepine treatment outside the prescription limits.
* Psychotic patients or patients with psychoactive substance addiction according to MINI KID criteria (Sheehan DV et al. Reliability and validity of the Mini International Neuropsychiatric Interview for children and adolescents (MINI Kid). J Clin Psychiatry 2010;71(3):313-326).
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CHU de Reims

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damien JOLLY

Reims, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien EUTROPE

Role: CONTACT

03 26 78 39 56 ext. 0033

Facility Contacts

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Julien EUTROPE

Role: primary

03 26 78 39 56 ext. 0033

Other Identifiers

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PR19054

Identifier Type: -

Identifier Source: org_study_id

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