Eating DisordersNCT05042869
Feasibility and Acceptability of a Body Dissatisfaction Program in Eating Disorders Patients
An observational study of Eating Disorders, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Eating Disorders
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 20 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eating Disorders patients participating in a body dissatisfaction management program
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Eating Disorders
- Keywords
- Psychiatry, Acceptance and Commitment Therapy, Body dissatisfaction
- Medical subject headings
- Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the body dissatisfaction program
Participation rate in group sessions
Measured: Day 1
Secondary outcomes (5)
Acceptability of the body dissatisfaction program
Satisfaction survey
Measured: day 1
Evolution of the eating disorder symptomatology
Eating disorder symptomatology assessed with the Eating Disorder Examination (EDE-Q). Higher scores on the global scale and
Measured: day 1
Evolution of the eating disorder symptomatology
Eating disorder symptomatology assessed with the Eating Disorder Inventory (EDI-2). Higher scores on the global scale and subscales indicate more severe disorder.
Measured: day 1
Evolution of the body dissatisfaction level
Level of body dissatisfaction assessed with EDE-Q body weight and shape concerns subscales. Higher scores indicate higher body dissatisfaction
Measured: day 1
Quality of life evolution
Quality of life assessed with Eating Disorders Quality Of Life
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Apr 2019
- Primary completion1 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Guillaume, MD.PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042869
- Sponsor's protocol ID
- RECHMPL21_0551
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study Evaluating Feasibility and Acceptability of a Psychological Management Program Focused on Body Dissatisfaction in Eating Disorders. SABG : Secondary Alveolar Bone Grafting
- ClinicalTrials.gov ID
- NCT05042869
- Acronym / sponsor ID
- RECHMPL21_0551
- Conditions
- Eating Disorders
- Keywords
- Psychiatry, Acceptance and Commitment Therapy, Body dissatisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 13 Sep 2021 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eating Disorders patients participating in a body dissatisfaction management program
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of the body dissatisfaction program
Time frame: Day 1
Participation rate in group sessions
5 secondary outcomes
Acceptability of the body dissatisfaction program
Time frame: day 1
Evolution of the eating disorder symptomatology
Time frame: day 1
Evolution of the eating disorder symptomatology
Time frame: day 1
Evolution of the body dissatisfaction level
Time frame: day 1
Quality of life evolution
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Sébastien Guillaume, MD.PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by University Hospital, Montpellier 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the body dissatisfaction program (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2021; AzTrials last refreshed its copy on 3 Nov 2026.