Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474689
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-16
Brief Title:
EMDR vs CBT in the Treatment of Inpatients With Obesity and Binge Eating Disorder the EMDRDCA Study
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Preliminary Findings of a Randomized Controlled Clinical Trial of EMDR vs Cognitive Behavioral Therapy in the Treatment of Inpatients With Obesity and Binge Eating Disorder the EMDRDCA Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMDRDCA
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None