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Randomized Study Assessing a Program of Body Dissatisfaction Psychological Care in Eating Disorders (INCCA)

Primary Purpose

Eating Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
body dissatisfaction management group
Relaxation Group
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring eating disorders, anorexia, bulimia, body dissatisfaction

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Body dissatisfaction management group

    relaxation group

    Arm Description

    ACT-inspired group for the management of body dissatisfaction

    standardized relaxation program

    Outcomes

    Primary Outcome Measures

    Body dissatisfaction
    Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction

    Secondary Outcome Measures

    Body dissatisfaction
    Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
    Body dissatisfaction
    Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
    eating behavior
    Assessment of eating behavior using Eating disorder Inventory (EDI-2). 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity. A high score reflects a higher intensity of symptoms
    eating behavior
    Assessment of eating behavior using Eating disorder Inventory (EDI-2). 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity. A high score reflects a higher intensity of symptoms
    eating behavior
    Assessment of eating behavior using Eating disorder Inventory (EDI-2) 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity. A high score reflects a higher intensity of symptoms
    Quality of life level
    Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL). EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
    Quality of life level
    Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL). EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
    Quality of life level
    Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL). EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
    Eating disorder symptomatology
    Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
    Eating disorder symptomatology
    Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
    Eating disorder symptomatology
    Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
    depressive symptomatology
    Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
    depressive symptomatology
    Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
    depressive symptomatology
    Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
    cognitive flexibility
    Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ). the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
    cognitive flexibility
    Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ). the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
    cognitive flexibility
    Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ). the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
    Global functioning
    Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
    Global functioning
    Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
    Global functioning
    Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
    mindfulness skills
    Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
    mindfulness skills
    Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
    mindfulness skills
    Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.

    Full Information

    First Posted
    January 26, 2022
    Last Updated
    January 26, 2022
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05227625
    Brief Title
    Randomized Study Assessing a Program of Body Dissatisfaction Psychological Care in Eating Disorders
    Acronym
    INCCA
    Official Title
    Randomized Controlled Trial Assessing the Effectiveness of a Psychological Management Program for Body Dissatisfaction in Eating Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2022 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders
    Keywords
    eating disorders, anorexia, bulimia, body dissatisfaction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Body dissatisfaction management group
    Arm Type
    Experimental
    Arm Description
    ACT-inspired group for the management of body dissatisfaction
    Arm Title
    relaxation group
    Arm Type
    Active Comparator
    Arm Description
    standardized relaxation program
    Intervention Type
    Behavioral
    Intervention Name(s)
    body dissatisfaction management group
    Intervention Description
    Our group is composed of 10 weekly session of 2 hours led by a psychologist trained in the management of ED and ACT therapy. Each group will be composed of 5 to 10 people. First of all, the group will lead the participants to better know and understand the impact of BD on the symptomatology of ED by teaching current scientific knowledge on the subject. In a second step, the group will guide the patients in the acquisition of psychological skills to deal with events related to BD and to engage in actions towards the values that give meaning to their existence.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Relaxation Group
    Intervention Description
    Participants will be included in a standardized relaxation program consisting of a weekly 2 hour session for 10 weeks. The group will be led by a psychologist trained in relaxation and in particular in abdominal and muscular relaxation techniques. Each group will be composed of 5 to 10 people. Initially, the therapy will lead the participants to recognize the signs of anxiety and to understand the physiological mechanisms involved. Classic techniques of anxiety management will then be introduced (cardiac coherence, abdominal and muscular relaxation, Jacobson technique, Schultz autogenic training). These techniques will be tested in session. Participants will be encouraged to practice these techniques at home.
    Primary Outcome Measure Information:
    Title
    Body dissatisfaction
    Description
    Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
    Time Frame
    immediate post intervention
    Secondary Outcome Measure Information:
    Title
    Body dissatisfaction
    Description
    Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
    Time Frame
    1 month post intervention
    Title
    Body dissatisfaction
    Description
    Assessment of body dissatisfaction using Body shape questionnaire (BSQ-34) 34-item self-administered questionnaire assessing body dissatisfaction across four dimensions: avoidance and social shame of body exposure, body dissatisfaction with lower parts of the body, use of laxatives and vomiting to reduce body dissatisfaction, cognitions and maladaptive behaviors to control weight. The total score ranges from 0 to 204. A score below 80 indicates no excessive body dissatisfaction, a score between 80 and 100 indicates mild body dissatisfaction, between 111 and 140 moderate body dissatisfaction and a score above 140 indicates severe body dissatisfaction
    Time Frame
    3 months post intervention
    Title
    eating behavior
    Description
    Assessment of eating behavior using Eating disorder Inventory (EDI-2). 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity. A high score reflects a higher intensity of symptoms
    Time Frame
    immediate post intervention
    Title
    eating behavior
    Description
    Assessment of eating behavior using Eating disorder Inventory (EDI-2). 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity. A high score reflects a higher intensity of symptoms
    Time Frame
    1 month post intervention
    Title
    eating behavior
    Description
    Assessment of eating behavior using Eating disorder Inventory (EDI-2) 91-item self-questionnaire aim to evaluate food-related attitudes and behaviors. 11 dimensions emerge : search for thinness, bulimia, dissatisfaction with the body, inefficiency, perfectionism, interpersonal mistrust, interoceptive awareness, fear of maturity, asceticism, impulse control, social insecurity. A high score reflects a higher intensity of symptoms
    Time Frame
    3 months post intervention
    Title
    Quality of life level
    Description
    Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL). EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
    Time Frame
    immediate post intervention
    Title
    Quality of life level
    Description
    Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL). EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
    Time Frame
    1 month post intervention
    Title
    Quality of life level
    Description
    Assessment of quality of life using the Eating Disorder Quality Of Life (EDQOL). EDQOL is a self-questionnaire assessing the quality of life, specific to eating disorders. 4 dimensions are assessed: Psychological, Physical/Cognitive, Financial, Work/School. The scale also produces an overall score. The higher the score, the more the eating disorder impacts the patient's quality of life
    Time Frame
    3 months post intervention
    Title
    Eating disorder symptomatology
    Description
    Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
    Time Frame
    immediate post intervention
    Title
    Eating disorder symptomatology
    Description
    Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
    Time Frame
    1 month post intervention
    Title
    Eating disorder symptomatology
    Description
    Assessment of Eating disorder symptomatology using the Eating disorder Examination (EDE-q). Self-administered questionnaire assessing the intensity of eating symptoms over the past 28 days. A total score as well as 4 sub-scores (restriction, diet, weight, shape) varying from 0 to 6. The higher the score, the more severe the symptoms.
    Time Frame
    3 months post intervention
    Title
    depressive symptomatology
    Description
    Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
    Time Frame
    immediate post intervention
    Title
    depressive symptomatology
    Description
    Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
    Time Frame
    1 month post intervention
    Title
    depressive symptomatology
    Description
    Assessment of depressive symptomatology using Montgomery Asberg Depression Scale (MADRS). This hetero-questionnaire assesses the intensity of the patient's depressive symptoms. The total score between 0 and 60 corresponds to the sum of the 10 items. The higher the score, the more severe the symptoms.
    Time Frame
    3 months post intervention
    Title
    cognitive flexibility
    Description
    Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ). the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
    Time Frame
    immediate post intervention
    Title
    cognitive flexibility
    Description
    Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ). the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
    Time Frame
    1 month post intervention
    Title
    cognitive flexibility
    Description
    Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ). the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptance
    Time Frame
    3 months post intervention
    Title
    Global functioning
    Description
    Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
    Time Frame
    immediate post intervention
    Title
    Global functioning
    Description
    Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
    Time Frame
    1 month post intervention
    Title
    Global functioning
    Description
    Assessment of Global functioning using the Work and Social Adjustment Scale . The WSAS is self-questionnaire of 5 items aimed at evaluating the consequences of the ED on the overall functioning of the patient. Each item is rated from 0 to 8. The score of the scale therefore varies from 0 (no functioning problem) to 40 (maximum problems). A score greater than 20 suggests a significant impairment in functioning. A score between 10 and 20 suggests moderate impairment. A score of less than 10 suggests no functioning problem
    Time Frame
    3 months post intervention
    Title
    mindfulness skills
    Description
    Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
    Time Frame
    immediate post intervention
    Title
    mindfulness skills
    Description
    Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
    Time Frame
    1 month post intervention
    Title
    mindfulness skills
    Description
    Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.
    Time Frame
    3 months post intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kathyne DUPUIS MAURIN
    Phone
    +33467335663
    Email
    k-dupuis@chu-montpellier.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    maude SENEQUE
    Phone
    +33467335663
    Email
    m-senequehaize@chu-montpellier.fr

    12. IPD Sharing Statement

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