Preliminary Findings of a Randomized Controlled Clinical Trial of EMDR vs. Cognitive Behavioral Therapy in the Treatment of Inpatients With Obesity and Binge Eating Disorder: the EMDRDCA Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- subjective distress caused by traumatic events
研究概览
简要总结
Overweight and obesity are linked with Binge Eating Disorder (BED). Traditionally, Cognitive Behavioral Therapy (CBT) is the therapeutic approach indicated both for inpatient and outpatient treatment of BED. Eye Movement Desensitization and Reprocessing (EMDR) could be more effective for the treatment of BED, in particular with patients who lived one or more traumatic experiences.
A randomized controlled clinical trial is ongoing in order to test the hypothesis that a 4-week EMDR intervention is more effective than a parallel CBT intervention in the treatment of inpatients with obesity and BED who experienced a traumatic event and are referred to a residential rehabilitation program. Outcomes are the reduction of binge eating symptoms, emotional eating, psychological distress and trauma-related variables, and the improvement of emotion regulation from baseline to treatment completion.
详细描述
Feeding and Eating disorders (FEDs) have been claimed to represent major global health concerns. FEDs include different types of disorders such as Anorexia Nervosa (AN), Bulimia Nervosa (BN), and Binge Eating Disorder (BED), which are all generally characterized by excessive preoccupation with body shape, eating, and weight, and may include disordered eating and compensatory behaviors.
BED is a relatively new FED introduced in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). It is characterized by frequent episodes of eating a large amount of food in a short period of time and with a sense of lack of control over eating, followed by a sense of guilt, not associated with compensatory behaviors such as vomiting.
There are several medical comorbidities with FEDs which can range from cardiac to metabolic, gastrointestinal, and reproductive complications. BED is associated with severe medical conditions including, among others, obesity and obesity-related disorders such as type 2 diabetes, hypertension, and dyslipidemia.
FEDs often present with psychiatric comorbidities. The most common FEDs-related psychiatric conditions are anxiety disorders (particularly obsessive-compulsive disorder, generalized anxiety disorder, and social phobia), mood disturbances such as major depression, and alcohol and substance abuse.
Treating FEDs requires a multidisciplinary approach with medical, nutritional, psychological and physical interventions. As far as psychotherapy is concerned, Cognitive Behavioral Therapy (CBT), in particular the Enhanced Cognitive Behavioral Therapy (CBT-E), has been recognized as the treatment of choice for FEDs. Although CBT-E is the most used approach to treat FEDs, there is some evidence suggesting weak long-term outcomes such as high percentages of dropout and unsatisfactory remission rates. These findings have motivated researchers to investigate the role of psychopathological mechanisms not adequately addressed by CBT-E, which can have an impact on the onset and the maintenance of FEDs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •being a female Italian inpatient with obesity (Body Mass Index BMI: Kg/m2>30, WHO) and BED (according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, DSM-5), aged between 18 and 65 years, and with a self-reported history of one traumatic experience at least.
排除标准
- •any physical or psychiatric disorder, or any other medical condition that could compromise participation in the RCT.
结局指标
主要结局
subjective distress caused by traumatic events
时间窗: 4 weeks
subjective distress caused by traumatic events is assessed with the Italian-validated version of the Impact of Event Scale-Revised. It is a self-report questionnaire composed of 22 items rated on a 5-point Likert scale ranging from 0 to 4 used to assess subjective distress caused by traumatic events. The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales. All subscales of the Italian version had good internal consistency (hyper-arousal, α = 0.83; avoidance, α = 0.72; intrusion, α = 0.78).
psychological distress
时间窗: 4 weeks
psychological distress is assessed with the Italian-validated version of the Depression Anxiety and Stress Scale (DASS). It is a self-report questionnaire composed of 21 items rated on a 4-point Likert scale, ranging from 0 to 3 and composing three subscales: depression, anxiety, and stress. The validation of the italian version showed that Cronbach's alpha coefficients exceeded .70 both in the community and clinical samples, thus indicating good to excellent internal consistency. Test-retest reliability values computed on the undergraduate student sample were large for all the DASS-21 scale scores.
emotional eating
时间窗: 4 weeks
emotional eating is assessed with the Emotional Eating subscale of the Italian-validated version of the Dutch Eating Behavior Questionnaire. It is composed of 13 items, rated on a 5-step Likert scale ranging from 0 to 4. The validation of the Italian version showed that DEBQ subscales have a high test-retest reliability. Cronbach's alpha coefficient for the Emotional Eating scale indicated an adequate internal consistency.
emotion dysregulation
时间窗: 4 weeks
emotion dysregulation is assessed with the Italian-validated version of the Difficulties in Emotion Regulation Scale. It is a self-report questionnaire consisting of 36 items, rated on a 5-point Likert scale ranging from 1 to 5, which explores the following sub-scales: non-acceptance of negative emotions, inability to undertake purposeful behavior when experiencing negative emotions, difficulty in controlling impulsive behavior when experiencing negative emotions, limited access to emotion regulation strategies that are considered effective, lack of awareness of one's emotions, lack of understanding of the nature of one's emotional responses. Results from the Italian validation showed that the DERS has high internal consistency with a Cronbach's alpha of .92 for the DERS total score and alphas \> .80 for most sub-scales. The test-retest reliability was excellent for the DERS total score, fair for Clarity, and good for Nonacceptance, Goals, Impulse, Awareness, and Strategies.
binge eating
时间窗: 4 weeks
binge eating is assessed with the Italian-validated version of the Binge Eating Scale. It is a self-report questionnaire composed of 16 groups of items assessing the presence of binge eating episodes. Specifically, 8 items describe behavior manifestations and 8 items refer to feelings and cognitions surrounding a binge episode. The total score ranged from 0 to 46. The higher the score, the more severe the binge eating problems. In an Italian study evaluating the psychometric properties of the Italian version of BES results showed good internal consistency reliability (α = 0.89)
次要结局
未报告次要终点