- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05042869
Feasibility and Acceptability of a Body Dissatisfaction Program in Eating Disorders Patients
Preliminary Study Evaluating Feasibility and Acceptability of a Psychological Management Program Focused on Body Dissatisfaction in Eating Disorders. SABG : Secondary Alveolar Bone Grafting
The cognitive model of Eating Disorders (ED) highlights dysfunctional cognitive patterns common to the different subtypes. Body dissatisfaction, which can be defined as the negative and subjective evaluation of one's body shape, i.e., negative thoughts and emotions concerning one's body image and the origin of pathological behaviours with the aim of modifying one's weight and body shape, thus appears to be a central transdiagnostic concept in the ED. It is, moreover, described as a major factor in the development, maintenance and relapse of the various types of ED.
It is suggested that Acceptance and Commitment Therapy (ACT) may be beneficial in treating body dissatisfaction insofar as body image inflexibility appears to influence the relationship between body image appraisal and coping strategies. ACT, which aims to develop psychological flexibility, appeared to us as a promising tool to manage body dissatisfaction in ED.
The investigators therefore aim to evaluate the feasibility and acceptability of a psychological management group for body dissatisfaction (9 or 10 weekly group session), based on ACT therapy, in patients suffering from an ED.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Montpellier, France, 34295
- UHMontpellier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Women over 16 years
- Eating disorder, according to DSM-5 criteria (all types of eating disorder are included: anorexia, bulimia, binge eating disorder, …)
- Marked body dissatisfaction
- BMI > 17.5 kg/m2
Exclusion criteria:
- Refusal to participate
- Current severe psychiatric condition other than an ED that may impair patients' ability to attend the group
- Pregnant or breastfeeding women
- Protection measure or deprivation of liberty by administrative decision
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the body dissatisfaction program
Time Frame: Day 1
|
Participation rate in group sessions
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the body dissatisfaction program
Time Frame: day 1
|
Satisfaction survey
|
day 1
|
Evolution of the eating disorder symptomatology
Time Frame: day 1
|
Eating disorder symptomatology assessed with the Eating Disorder Examination (EDE-Q).
Higher scores on the global scale and
|
day 1
|
Evolution of the eating disorder symptomatology
Time Frame: day 1
|
Eating disorder symptomatology assessed with the Eating Disorder Inventory (EDI-2).
Higher scores on the global scale and subscales indicate more severe disorder.
|
day 1
|
Evolution of the body dissatisfaction level
Time Frame: day 1
|
Level of body dissatisfaction assessed with EDE-Q body weight and shape concerns subscales.
Higher scores indicate higher body dissatisfaction
|
day 1
|
Quality of life evolution
Time Frame: day 1
|
Quality of life assessed with Eating Disorders Quality Of Life
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sébastien Guillaume, MD.PhD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL21_0551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eating Disorders
-
Bezmialem Vakif UniversityMuğla Sıtkı Koçman University; The Scientific and Technological Research Council... and other collaboratorsActive, not recruitingEating Disorders | Eating Behavior | Orthodontic Appliance Complication | Eating HabitTurkey
-
University of North Carolina, Chapel HillThe Hilda & Preston Davis Foundation; Global Foundation for Eating DisordersCompletedEating Disorder | Binge-eating DisorderUnited States
-
Shalvata Mental Health CenterUniversity of Haifa; The Touro College and University SystemUnknownBinge-Eating Disorder | Bulimia Nervosa | Night-eating Syndrome
-
Sao Jose do Rio Preto Medical SchoolFundação de Amparo à Pesquisa do Estado de São PauloCompletedBinge-Eating Disorder | Eating Disorders | Eating Behavior | Eating Disorder | Binge Eating Disorder Associated With ObesityBrazil
-
ShireCompleted
-
Lindner Center of HOPEUniversity of CincinnatiCompleted
-
Stanford UniversityNational Institute of Mental Health (NIMH)RecruitingEating DisorderUnited States
-
Cornell CollegeNational Institute of Mental Health (NIMH)Completed
-
McMaster UniversityCompletedEating DisorderCanada
-
Washington University School of MedicineCompletedEating Disorder