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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05042869
Other study ID # RECHMPL21_0551
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date February 20, 2020

Study information

Verified date September 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date February 20, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of the body dissatisfaction program Participation rate in group sessions Day 1
Secondary Acceptability of the body dissatisfaction program Satisfaction survey day 1
Secondary Evolution of the eating disorder symptomatology Eating disorder symptomatology assessed with the Eating Disorder Examination (EDE-Q). Higher scores on the global scale and day 1
Secondary 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. day 1
Secondary 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 day 1
Secondary Quality of life evolution Quality of life assessed with Eating Disorders Quality Of Life day 1
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