Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Plus Broad Form of Enhanced Cognitive Behavioural Therapy (CBT-Eb) in Patients With Eating Disorders. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in Severity of the Eating Disorder
研究概览
简要总结
Enhanced CBT (CBT-E) is an effective treatment for the majority of outpatients with an eating disorder; however in about 30% of patients remission is made difficult. This may be due to the concomitant presence of trauma. Therefore we expect that a combination of CBT-E and EMDR, which is the evidence based treatment for PTSD disorder, would enhance the remission probability. This trial has a parallel group randomized controlled design. All patients who will enter in contact with the Regional Reference Centre for Eating Disorders in Verona and will satisfy inclusion criteria will be randomized to the broad form of CBT-E (CBT-Eb) plus EMDR or CBT-Eb alone. Patients will be evaluated before the treatment, at the end of treatment and after 6 months post-treatment with a set of standardized measure to assess eating disorder symptoms and other possible predisposing and moderating factors. The efficacy of CBT-E vs CBT-E + EMDR will be evaluated at the end of the treatment and after 6 months in terms of global score of the Eating Disorder Examination. Moreover the changes in other secondary outcomes will be considered. This explorative study may suggest new hypothesis for larger RCTs in order to increase the knowledge on ED.
详细描述
Background. The Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) distinguishes three broad categories of Eating Disorder (ED): anorexia nervosa (AN), bulimia nervosa (BN), and Other Specified Feeding or Eating Disorder (OSFED). The International Classification of Diseases tenth revision (ICD-10) also reports three categories: anorexia nervosa, bulimia nervosa, and atypical eating disorder.
Anorexia Nervosa (AN). Anorexia nervosa, which primarily affects adolescent girls and young women, is characterized by distorted body image and excessive dieting that lead to severe weight loss with a pathological fear of becoming fat. People affected by anorexia often go to great attempts to hide their behaviour from family and friends. Often people with anorexia have low confidence and poor self-esteem. They can see their weight loss as a positive achievement that can help increase their confidence. It can also contribute to a feeling of gaining control over body weight and shape. The illness can affect people's relationship with family and friends, causing them to withdraw; it can also have an impact on how they perform in education or at work. The seriousness of the physical and emotional consequences of the condition is often not acknowledged or recognised and people with anorexia often do not seek help.
Bulimia Nervosa (BN). Bulimia nervosa is a serious disorder that involves a recurring pattern of binge eating followed by dangerous compensatory behaviours in an effort to counteract or "undo" the calories consumed during the binge. Marked distress regarding binge eating is present. The binge eating occurs, on average, at least once a week for three months. People with bulimia often feel trapped in this cycle of dysregulated eating, and there is a risk for major medical consequences associated with bulimic behaviours.
Other Specified Feeding or Eating Disorder (OSFED). It is a feeding or eating disorder that causes significant distress or impairment, but does not meet the criteria for another feeding or eating disorder.
Treatment of Eating Disorders. Guidelines recommended that people with anorexia nervosa should first be offered outpatient treatment and that inpatient care be used for those who do not respond or who present with high risk and little psychosocial resources. Nevertheless the evidence base relating to the treatment of anorexia nervosa is meagre and no first line treatment is identified. Recommendations emphasise the importance of a multi-disciplinary approach including medical, nutritional, social, and psychological components. Among psychotherapies, CBT is one of the suggested treatment. For atypical eating disorders (eating disorders not otherwise specified), in the absence of evidence "it is recommended that the clinician considers following the guidance on the treatment of the eating problem that most closely resembles the individual patient's eating disorder". Regarding bulimia nervosa, CBT-BN is recommended as first-line treatment. CBT-BN has evolved over the past decade in response to a variety of challenges: its procedures have been refined, particularly those addressing patients over evaluation of shape and weight, and it has been adapted to make it suitable for all forms of eating disorder, thereby making it "transdiagnostic" in its scope. This implemented CBT treatment was defined Enhanced CBT. Several studies addressed the efficacy of CBT-E across several eating disorders. In detail, there are two possible CBT treatments for eating disorders, a simpler one, more focused on eating disorders features defined as focused form of Enhanced CBT (CBT-Ef) and another more complex, that addresses external psychopathological processes, named broad form of Enhanced CBT (CBT-Eb). This new version of the treatment also addresses psychopathological processes "external" to the eating disorder, such as clinical perfectionism, low self-esteem or interpersonal difficulties, which interact with the disorder itself.
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
- 14 Years 至 45 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 14 and 45 years
- •Diagnosis of Eating Disorder that meets DSM 5 diagnostic criteria for Anorexia Nervosa (AN), Bulimia Nervosa (BN) or Other Specified Feeding or Eating Disorder (OSFED)
- •A clinical severity which permits to treat the person at out-patient level
排除标准
- •Eating Disorder of high clinical severity, not treatable at out-patient level
- •Comorbidity with psychotic symptoms or any other DSM 5 disorder which might hinder eating disorder treatment
- •Medical conditions which might impede data interpretation (chemotherapy, pregnancy status)
- •Substances use and abuse
- •Having previously received an evidence-based CBT treatment for the same eating disorder and/or EMDR
结局指标
主要结局
Changes in Severity of the Eating Disorder
时间窗: From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1)
Global score of the Eating Disorder Examination (EDE)
次要结局
- Changes in Assertiveness(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Eating disorder risk factors(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Level of impulsiveness(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Brooding(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Maladaptive schemes(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Psychopathological conditions(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in the Number of patients "in remission" for general psychopathology(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Subjective impact of traumatic events(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Intensity of dissociative experiences(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Caregiver expressed emotions (from the patient point of view)(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Global functioning(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Alexithymia(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Psychosocial damage(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
- Changes in Hypomanic or manic symptoms(From t1 (at 9 months from BL if BMI>17.5 and 14 months from BL if BMI<=17.5) to t2 (after 6 months from t1))
研究者
Ruggeri, Mirella
Full Professor in Psychiatry
Universita di Verona
