Randomized Study Assessing a Program of Body Dissatisfaction Psychological Care in Eating Disorders
- Conditions
- Eating Disorders
- Interventions
- Behavioral: body dissatisfaction management groupBehavioral: Relaxation Group
- Registration Number
- NCT05227625
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 128
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Body dissatisfaction management group body dissatisfaction management group ACT-inspired group for the management of body dissatisfaction relaxation group Relaxation Group standardized relaxation program
- Primary Outcome Measures
Name Time Method Body dissatisfaction immediate post intervention 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
Name Time Method Body dissatisfaction 3 months post intervention 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 disorder symptomatology 3 months post intervention 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.
cognitive flexibility 3 months post intervention Assessment of cognitive flexibility using the Acceptance and Action Questionnaire (AAQ).
the AAQ is 7-item self-questionnaire to assess psychological flexibility and psychological acceptanceGlobal functioning 3 months post intervention 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
eating behavior 3 months post intervention 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 symptomsQuality of life level 3 months post intervention 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 lifedepressive symptomatology 3 months post intervention 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.
mindfulness skills 3 months post intervention Assessment of mindfulness skills using Mindful Attention Awarness Scale (MAAS). 15-item self-questionnaire to assess spontaneous mindfulness skills.