EMDR vs. CBT in the Treatment of Inpatients With Obesity and Binge Eating Disorder: the EMDRDCA Study.
NCT Number: NCT06474689
Acronym: EMDRDCA
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Binge-Eating Disorder
Interventions: OTHER: EMDR|OTHER: CBT
Sponsor: Istituto Auxologico Italiano
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 8
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-12-01
Locations: istituto Auxologico Italiano - Piancavallo, Piancavallo, Verbania, 28824, Italy

Summary:
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.

Primary Outcome Measures: subjective distress caused by traumatic events, 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)., 4 weeks|binge eating, 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), 4 weeks|psychological distress, 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., 4 weeks|emotional eating, 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., 4 weeks|emotion dysregulation, 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., 4 weeks