NCT04107870

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
28mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jun 2021Sep 2028

First Submitted

Initial submission to the registry

September 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 20, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2028

Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

5.8 years

First QC Date

September 26, 2019

Last Update Submit

March 7, 2023

Conditions

Anorexia Nervosa

Keywords

ANOREXIA NERVOSAFEMALE ADOLESCENTSBODY DYSMORPHIC DISORDERVIRTUAL REALITY EXPOSURE THERAPY

Outcome Measures

Primary Outcomes (1)

  • 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".

    12 months

Secondary Outcomes (1)

  • Eating Disorder Inventory

    12 months

Study Arms (2)

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

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.

Behavioral: Psychomotor therapy sessions

Interventions

Virtual Reality Exposure Therapy sessionsBEHAVIORAL

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

Virtual Reality Exposure Therapy
Psychomotor therapy sessionsBEHAVIORAL

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.

Psychomotor Therapy

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaBody Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersSomatoform Disorders

Central Study Contacts

Julien EUTROPE

CONTACT

03 26 78 39 56jeutrope@chu-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 27, 2019

Study Start

June 20, 2021

Primary Completion (Estimated)

March 20, 2027

Study Completion (Estimated)

September 20, 2028

Last Updated

March 8, 2023

Record last verified: 2023-03

Locations

FR(1)