Clinical Trial: CBT-Eb Plus EMDR Versus CBT-Eb in Patients With Eating Disorders

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Plus Broad Form of Enhanced Cognitive Behavioural Therapy (CBT-Eb) in Patients With Eating Disorders. A Ra

Brief Summary: 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.

Detailed Summary:

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 wi
Sponsor: Ruggeri, Mirella

Current Primary Outcome:

• Changes in Severity of the Eating Disorder [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Global score of the Eating Disorder Examination (EDE)
• Changes in Severity of the Eating Disorder [ Time Frame: 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)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Changes in Psychopathological conditions [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Hopkins Symptom Checklist (SCL-90)
• Changes in Psychopathological conditions [ Time Frame: 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) ]
  Hopkins Symptom Checklist (SCL-90)
• Changes in the Number of patients "in remission" for general psychopathology [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Global SCL-90 score less than 1
• Changes in the Number of patients "in remission" for general psychopathology [ Time Frame: 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 SCL-90 score less than 1
• Changes in Eating disorder risk factors [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Eating Disorders Inventory (EDI.3)
• Changes in Eating disorder risk factors [ Time Frame: 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) ]
  Eating Disorders Inventory (EDI.3)
• Changes in Subjective impact of traumatic events [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Impact of Event Scale-Revised (IES-R)
• Changes in Subjective impact of traumatic events [ Time Frame: 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) ]
  Impact of Event Scale-Revised (IES-R)
• Changes in Intensity of dissociative experiences [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Dissociative Experience Scale (DIS-Q)
• Changes in Intensity of dissociative experiences [ Time Frame: 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) ]
  Dissociative Experience Scale (DIS-Q)
• Changes in Caregiver expressed emotions (from the patient point of view) [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Level of Expressed Emotions (LEE)
• Changes in Caregiver expressed emotions (from the patient point of view) [ Time Frame: 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) ]
  Level of Expressed Emotions (LEE)
• Changes in Global functioning [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Global Assessment of Functioning (GAF)
• Changes in Global functioning [ Time Frame: 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 Assessment of Functioning (GAF)
• Changes in Level of impulsiveness [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Barratt Impulsiveness Scale (BIS-11)
• Changes in Level of impulsiveness [ Time Frame: 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) ]
  Barratt Impulsiveness Scale (BIS-11)
• Changes in Alexithymia [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Toronto Alexithymia Scale (TAS-20)
• Changes in Alexithymia [ Time Frame: 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) ]
  Toronto Alexithymia Scale (TAS-20)
• Changes in Assertiveness [ Time Frame: From BL to t1 (at 9 months if BMI>17.5 and 14 months if BMI<=17.5) ]
  Rathus Assertiveness Scale (RAS)
• Changes in Assertiveness [ Time Frame: 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) ]
  Rathus Assertiveness Scale (RAS)
• Changes in Brooding [ Time Frame
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Universita di Verona
  

  Dates:
  Date Received: May 8, 2017
  Date Started: May 22, 2017
  Date Completion: December 31, 2022
  Last Updated: May 17, 2017
  Last Verified: May 2017