Clinical trial NCT05227625: Randomized Study Assessing a Program of Body Dissatisfaction Psychological Care in Eating Disorders
Official title: Randomized Controlled Trial Assessing the Effectiveness of a Psychological Management Program for Body Dissatisfaction in Eating Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Keywords: eating disorders
anorexia
bulimia
body dissatisfaction
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 128
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eating disorders (ED) are a major public health problem for which current treatments are insufficiently effective. The transdiagnostic approach of eating disorders highlights body dissatisfaction (BD) as a major factor in the development and maintenance of the different types of eating disorders. Thus, we hypothesize that a group focused on the management of BDc would improve the prognosis of patients with eating disorders.

Detailed description: Main and secondary objectives: To evaluate the effectiveness of a BD management group on the level of body dissatisfaction in patients suffering from an ED (BSQ-34 total score immediately after intervention). Secondary: To assess the effectiveness of a BD management group in 1) reducing the desire for thinness, 2) improving quality of life, 3) improving ED symptoms, 4) improvement in depressive symptomatology, 5) increase in cognitive flexibility and acceptance of unpleasant psychological events, 6) improvement in overall functioning.

Methodology : Open randomized controlled trial with two intervention arms (management of BD versus relaxation). Main inclusion criteria: patients over 16 years of age suffering from an ED, presenting moderate to severe BD (BSQ-34≥111) and normal BMI

Main endpoint: evolution of the level of BD (BSQ-34) immediately after the intervention. Secondary judgment criteria: change in the level of BD (BSQ-34) at 1 and 3 months post-intervention \& change in eating symptomatology (EDI, EDE-Q), quality of life (EDQOL), level of depression (MADRS), cognitive flexibility ( AAQ), functioning (WSAS) immediately post-intervention, at 1 and 3 months post-intervention.

Procedure: The participation of each patient includes 4 evaluation visits: inclusion, just after the end of the intervention, at 1 and 3 months after the end of the intervention

Benefits / prospects: We hope that patients who have integrated the interventional group will show a significant improvement in their BD, their functioning and the overall prognosis of the disorder. Positive results would permit to consider a larger multicenter study evaluating the long-term effect of the group on different dimensions of the ED. Finally, it would then be possible to offer standardized care that can be generalized to other centers.

Eligibility criteria: Inclusion Criteria:

* ED according to DSM 5 criteria (all types of ED can be included: anorexia, bulimia, binge eating disorder, atypical ED, etc.)
* BMI between 18.5 kg/m2 and 24.9 kg/m2).
* woman over the age of 16
* moderate to severe body dissatisfaction (total BSQ score greater than or equal to 111)

Exclusion Criteria:

* current severe psychiatric pathology other than the TCA (severe depression, schizophrenia, etc.) which may alter the ability to follow the group in the opinion of the investigator
* Patient under legal protection measure (guardianship, curatorship, safeguard of justice, authorization family or future protection mandate activated
* Pregnant or breastfeeding women according
* Patient not affiliated to a social security scheme, or beneficiary of such a scheme
* Patient unable to understand the nature, purpose and methodology of the study
* Patient who did not sign the informed consent
* Patient whose legal guardian has not given consent to inclusion

Primary outcomes:
measure: Body dissatisfaction
timeFrame: immediate post intervention
Secondary outcomes:
measure: Body dissatisfaction
timeFrame: 1 month post intervention
measure: Body dissatisfaction
timeFrame: 3 months post intervention
measure: eating behavior
timeFrame: immediate post intervention
measure: eating behavior
timeFrame: 1 month post intervention
measure: eating behavior
timeFrame: 3 months post intervention
measure: Quality of life level
timeFrame: immediate post intervention
measure: Quality of life level
timeFrame: 1 month post intervention
measure: Quality of life level
timeFrame: 3 months post intervention
measure: Eating disorder symptomatology
timeFrame: immediate post intervention
measure: Eating disorder symptomatology
timeFrame: 1 month post intervention
measure: Eating disorder symptomatology
timeFrame: 3 months post intervention
measure: depressive symptomatology
timeFrame: immediate post intervention
measure: depressive symptomatology
timeFrame: 1 month post intervention
measure: depressive symptomatology
timeFrame: 3 months post intervention
measure: cognitive flexibility
timeFrame: immediate post intervention
measure: cognitive flexibility
timeFrame: 1 month post intervention
measure: cognitive flexibility
timeFrame: 3 months post intervention
measure: Global functioning
timeFrame: immediate post intervention
measure: Global functioning
timeFrame: 1 month post intervention
measure: Global functioning
timeFrame: 3 months post intervention
measure: mindfulness skills
timeFrame: immediate post intervention
measure: mindfulness skills
timeFrame: 1 month post intervention
measure: mindfulness skills
timeFrame: 3 months post intervention
Other outcomes:
Locations:
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