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

NCT ID: NCT06474689

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-12-01

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.

Detailed Description

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.

History of trauma and early negative experiences in life such as neglect and abuse as well as stressful life events have been recognized as common risk factors for FEDs, and as predictors of worse treatment outcomes when not properly targeted. Since CBT-E does not specifically target trauma-related symptoms, it can be hypothesized that the treatment of FEDs could benefit from a trauma-focused therapy.

Eye Movement Desensitization and Reprocessing (EMDR) is a trauma-focused therapeutic approach developed by Shapiro in 1987 for the treatment of Post Traumatic Stress Disorder (PTSD) and traumatic psychopathological features as dissociation. To date, several systematic reviews and meta-analyses reported EMDR to be effective in the treatment of PTSD and trauma-related comorbidities.

Because trauma history is prominent in FEDs, and EMDR has proven efficacy in the treatment of trauma and trauma-related disorders, some authors have argued that EMDR could be a beneficial approach to be used for the treatment of FEDs. However, only a few studies addressing this hypothesis are available. For example, Zaccagnino and colleagues illustrated a clinical case in which a 17-year-old inpatient with unremitting AN followed an EMDR intervention for 6 months in hospital. From pre-to-post-treatment, the patient increased weight, and BMI, improved her attachment style, and increased self-confidence and social functioning, and results were maintained at 12 and 24 months follow-up. Ergüney-Okumuş described the positive effects of EMDR on a patient with BN, who received 20 sessions of CBT-E followed by 5 sessions of EMDR with a focus on body image. After the intervention, the patient reported important improvements in eating-related symptoms (binge eating, restricting, and preoccupation with weight, shape, and eating) as well as motivation, body satisfaction, and social relations.

To the best of the authors' knowledge, there is no evidence concerning the efficacy of EMDR in the treatment of subjects with BED. For this reason, a two-arm randomized controlled clinical trial (RCT) with a mixed between-within design was planned in order to test the superior efficacy of a 4-week EMDR intervention compared to a parallel CBT intervention in the treatment of inpatients with BED and comorbid obesity, and who experienced traumatic events in their lives.

The EMDR intervention was hypothesized to be more effective than the CBT intervention in reducing the impact of traumatic experiences, BED symptoms, emotional eating, and psychological distress, and in improving emotion regulation.

The RCT is ongoing at the IRCCS Istituto Auxologico Italiano, Piancavallo (VCO, Italy), a third-level, residential clinical center for the rehabilitation of obesity and eating disorders.

Patients attending the inpatient program described below are screened for inclusion into the RCT during the first hospitalization week. After a routine clinical interview conducted by an independent licensed psychologist, patients who meet the eligibility criteria are invited to participate in the RCT by a member of the research team, who informs them about the RCT objectives and procedures. Eligible patients who accept to participate and sign the informed consent forms for participation and data treatment are asked to complete a battery of self-report questionnaires to collect demographic data and measure outcome variables. The questionnaires completed by participants are stored in a locked cabinet, while data are stored in a password-protected Excel file.

Conditions

Binge-Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EMDR

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.

Group Type: EXPERIMENTAL

EMDR

Intervention Type: 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.

CBT

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.

Group Type: ACTIVE_COMPARATOR

CBT

Intervention Type: 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.

Interventions

EMDR

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.

Intervention Type: OTHER

CBT

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

istituto Auxologico Italiano - Piancavallo

Piancavallo, Verbania, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Gianluca Castelnuovo, Prof

Role: primary

gianluca.castelnuovo@auxologico.it

0039323514338

Other Identifiers

AGU2024

Identifier Type: -

Identifier Source: org_study_id