NCT05042869

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

April 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

September 1, 2021

Last Update Submit

September 6, 2021

Conditions

Keywords

PsychiatryAcceptance and Commitment TherapyBody dissatisfaction

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the body dissatisfaction program

    Participation rate in group sessions

    Day 1

Secondary Outcomes (5)

  • Acceptability of the body dissatisfaction program

    day 1

  • Evolution of the eating disorder symptomatology

    day 1

  • Evolution of the eating disorder symptomatology

    day 1

  • Evolution of the body dissatisfaction level

    day 1

  • Quality of life evolution

    day 1

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eating Disorders patients participating in a body dissatisfaction management program

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Sébastien Guillaume, MD.PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 13, 2021

Study Start

April 1, 2019

Primary Completion

February 1, 2020

Study Completion

February 20, 2020

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations