Randomized Controlled Trial Assessing the Effectiveness of a Psychological Management Program for Body Dissatisfaction in Eating Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 主要终点
- Body dissatisfaction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Body dissatisfaction
时间窗: 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
次要结局
- Body dissatisfaction(3 months post intervention)
- Eating disorder symptomatology(3 months post intervention)
- cognitive flexibility(3 months post intervention)
- Global functioning(3 months post intervention)
- eating behavior(3 months post intervention)
- Quality of life level(3 months post intervention)
- depressive symptomatology(3 months post intervention)
- mindfulness skills(3 months post intervention)