Anorexia NervosaANO-TERVNCT04107870
Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa
A study testing Virtual Reality Exposure Therapy sessions and Psychomotor therapy sessions in people with Anorexia Nervosa, run by CHU de Reims at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Virtual Reality Exposure Therapy sessions and Psychomotor therapy sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2021to 20 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Julien EUTROPE, 03 26 78 39 56 ext. 0033, jeutrope@chu-reims.fr
About this study
Official title: Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorder in Female Adolescents With Anorexia Nervosa: a Randomized, Controlled Superiority Study
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.
Read the detailed description
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
- Anorexia Nervosa
- Being tested
- Virtual Reality Exposure Therapy sessions, Psychomotor therapy sessions
- Keywords
- ANOREXIA NERVOSA, FEMALE ADOLESCENTS, BODY DYSMORPHIC DISORDER, VIRTUAL REALITY EXPOSURE THERAPY
- Medical subject headings
- Anorexia Nervosa, Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure Therapy sessionsBehavioural
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 sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | 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 Receives: Behavioral: Virtual Reality Exposure Therapy sessions |
| Psychomotor Therapy | Active comparator | 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. Receives: Behavioral: Psychomotor therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Shape Questionnaire
The Body Shape Questionnaire (BSQ) measures concerns about body shape. The BSQ can be divided into 4 sub scores: "avoidance and social shame of body exposure", "body dissatisfaction with lower body parts", "use of laxatives and vomiting to reduce body dissatisfaction" and "inappropriate cognitions and behaviours to control weight".
Measured: 12 months
Secondary outcomes (1)
Eating Disorder Inventory
Eating Disorder Inventory (EDI-2) is a self questionnaire to assess the severity of symptoms of eating disorders and to evaluate their changes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start20 Jun 2021
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107870
- Sponsor's protocol ID
- PR19054
- Acronym
- ANO-TERV
- Status last verified
- Mar 2023
- First submitted
- 26 Sep 2019
- Last updated
- 8 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kierbel Y, Manes A, Barbe C, Rolland AC, Stocker A, Lamourette M, Rolling J, Eutrope J. Effectiveness of virtual reality exposure therapy in improving body dissatisfaction and shape-related concerns in adolescent girls with anorexia nervosa: a controlled, randomized, superiority trial. Trials. 2026 Aug 6;27(1):642. doi: 10.1186/s13063-026-09929-4.
PubMed 42972396
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorder in Female Adolescents With Anorexia Nervosa: a Randomized, Controlled Superiority Study
- ClinicalTrials.gov ID
- NCT04107870
- Acronym / sponsor ID
- ANO-TERV / PR19054
- Conditions
- Anorexia Nervosa
- Keywords
- ANOREXIA NERVOSA, FEMALE ADOLESCENTS, BODY DYSMORPHIC DISORDER, VIRTUAL REALITY EXPOSURE THERAPY
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Sep 2028 (estimated)
- First posted
- 27 Sep 2019 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Exposure Therapy | Experimental | Behavioral: Virtual Reality Exposure Therapy sessionsFemale 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 | Active comparator | Behavioral: Psychomotor therapy sessionsPsychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (0 listed)
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 Reality Exposure Therapy sessionsFemale 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 | Behavioural | Virtual Reality Exposure Therapy |
| Psychomotor therapy sessionsPsychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations. | Behavioural | Psychomotor Therapy |
Primary outcome
Body Shape Questionnaire
Time frame: 12 months
The Body Shape Questionnaire (BSQ) measures concerns about body shape. The BSQ can be divided into 4 sub scores: "avoidance and social shame of body exposure", "body dissatisfaction with lower body parts", "use of laxatives and vomiting to reduce body dissatisfaction" and "inappropriate cognitions and behaviours to control weight".
1 secondary outcome
Eating Disorder Inventory
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 42972396Kierbel Y, Manes A, Barbe C, Rolland AC, Stocker A, Lamourette M, Rolling J, Eutrope J. Effectiveness of virtual reality exposure therapy in improving body dissatisfaction and shape-related concerns in adolescent girls with anorexia nervosa: a controlled, randomized, superiority trial. Trials. 2026 Aug 6;27(1):642. doi: 10.1186/s13063-026-09929-4.
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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.
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 Exposure Therapy sessions and Psychomotor therapy sessions in people with Anorexia Nervosa, run by CHU de Reims 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 23 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 8 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien EUTROPE (03 26 78 39 56 ext. 0033, jeutrope@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Shape Questionnaire (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04107870, which also lists 1 linked publication.
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 8 Mar 2023.