EMDR vs. CBT in the Treatment of Inpatients With Obesity and Binge Eating Disorder: the EMDRDCA Study.

NCT06474689 | Recruiting

• 1 other identifier: AGU2024
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Binge-Eating Disorder

Keywords

Binge Eating disorder; Obesity; Trauma; Cognitive Behavioral Therapy; Eye Movement Desensitization and Reprocessing

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

EMDR

EXPERIMENTAL

The EMDR intervention is based on the standard protocol of EMDR, a therapeutic approach used for the treatment of trauma and stress-related disturbances. It focuses on the memory of traumatic experiences and is a comprehensive methodology that uses eye movements or other forms of dual attentional bilateral stimulation to treat disorders related directly to traumatic or particularly stressful experiences.

Other: EMDR

CBT

ACTIVE COMPARATOR

The CBT intervention is based on the core principles of both the Enhanced Cognitive Behavioral Therapy (CBT-E), an evidence-based treatment for eating disorders, and the Cognitive Behavioral Therapy for Obesity (CBT-OB). CBT-E is based on the transdiagnostic theory for eating disorders. CBT-OB combines the principal strategies of the traditional behavioral therapy for obesity (self-monitoring, goal setting, stimulus control) with more specific cognitive strategies and procedures helping patients to address the cognitive processes involved with treatment discontinuation, the amount of weight lost and long-term weight-loss maintenance.

Other: CBT

Interventions

EMDR OTHER

EMDR is based on the Adaptive Information Process (AIP) model, which posits that the traumatic event experienced by a subject is stored in memory along with the disturbing emotions, perceptions, cognitions, and physical sensations that characterized that moment. All this information is stored in a dysfunctional way within neural networks and unable to connect with other networks with useful information. The information enclosed in the neural networks, not being able to be processed, continue to cause discomfort in the subject, up to the onset of pathologies such as post-traumatic stress disorder (PTSD) and other psychological disorders. The goal of EMDR is to restore the adaptive processing of information in order to achieve the adaptive resolution by creating new and more functional connections.

EMDR

CBT OTHER

CBT-E is based on the transdiagnostic theory for eating disorders. According to this theory, there is an overvaluation of shape, weight, eating and their control that people use to judge themselves which represents the core feature of maintaining eating disorder symptoms including binge eating. The goals of CBT-E are to increase the understanding of eating disorders, reduce weight concerns, and establish a pattern of regular eating by addressing the mechanisms that have been maintaining the eating disorder psychopathology including body image disturbances and reactions to life events and emotions. The goals of CBT-OB are to help patients to reach, accept and maintain a healthy weight loss by adopting a healthy lifestyle.

CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• any physical or psychiatric disorder, or any other medical condition that could compromise participation in the RCT.

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

istituto Auxologico Italiano - Piancavallo

Piancavallo, Verbania, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Binge-Eating Disorder; Obesity; Wounds and Injuries

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 26, 2024
• Study Start: May 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)