Effects of EMDR Therapy in Patients With Severe Obesity

Study Overview
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Brief Summary
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The aims of the study are to perform psychological intervention using EMDR Therapy (Eye Movement Desensitization and Reprocessing Therapy) in the preoperative period, evaluate the personality of each patient through the PFB test (Personality Factor Battery Test) at different times, compare the results obtained in the PFB test at different times of application and verify the existence of changes in the five major Personality Factors: Neuroticism, Extroversion, Socialization, Realization and Openness.

Detailed Description
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Obesity is a multi-factorial disease requiring a multi-professional approach. Psychological causes also contribute to the development and maintenance of obesity. Traumatic experiences may be a risk factor for it as well. Emotional issues of obese patient often interfere with the results of bariatric surgery, where a large number of bariatric patients regain the weight or change symptoms. The aim of the Effects of EMDR therapy with Severe Obesity Bariatric Surgery Patients randomized controlled trial is to determine the effects of 11 sessions of EMDR therapy, prior to surgery as compared to a control group. The Big Five personality factors will be used to evaluate the results. Both groups of patients will complete the Factorial Personality Battery, before the surgery, and 6 months and 12 months following bariatric surgery. The initial hypothesis is that EMDR therapy will provide sufficient changes after surgery in the personality dynamics of obese patients, which will in turn favor emotional balance and weight maintenance as compared to the control group.

Official Title
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Effects of EMDR Therapy in Patients With Severe Obesity Submitted to Bariatric Surgery

Conditions
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Obesity, Emotional Trauma

Intervention / Treatment
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* Behavioral: Personality Factor Battery Test (PFB Test)
* Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both sexes BMI between 40 Kg/m2 and 50 Kg/m2 ages between 30 and 55 years, minimum level of Elementary School, previously evaluated psychologically by the Psychology Service - University of São Paulo Medical School Exclusion Criteria: history of severe personality disorders: psychotic symptoms or schizophrenia; bipolar disorder or dementia - groups A and B (DSM - IV); patients who present severe dissociative disorders (score above 25%), evaluated through the Dissociative Experiences Scale (DES); patients with heart problems and current pregnancy, with information obtained through the participants' reports.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Controlled Group<br>30 morbid obese patients, 30 to 55 years old, submitted to Personality Factor Battery Test (PFB Test) during the study with the same frequency and criteria of the group of EMDR . | Behavioral: Personality Factor Battery Test (PFB Test)<br>* Psychological instrument built for personality evaluation from the model of the Five Great Factors (FGF), that includes the following dimensions: Neuroticism, Extroversion, Socialization, Effort / Commitment), focusing on the component of the aspects of Neuroticism.<br>|
| Active Comparator: EMDR Group<br>30 morbid obese patients, 30 to 55 years old, submitted to Eye Movement Desensitization and Reprocessing Therapy (EMDR) during the study with the frequency of Twelve sessions, including: Three evaluation and preparation sessions, Eight EMDR sessions weekly with variable length of 60 minutes and One closing session. The total intervention time will be about 3 (three) months. After the end of the 12 sessions of EMDR therapy, the patient will be evaluated again individually to verify the existence of change in PFB test results about the 5 big factors. The instrument will also be reapplied three months, twelve months and thirty-six months after bariatric surgery. | Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR)<br>* It is a psychotherapeutic approach effective on treatment for trauma and post-traumatic stress disorder. It is an intervention that allows the desensitization of negative emotions from traumatic experiences.This therapy modifies memories that have been processed non-adaptively and become painful and dysfunctional memories. During the procedure, the patient is encouraged to move the eyes from side to side, associating these movements with a target situation, previously defined at the beginning of the session. The ocular movements can be replaced by tactile or sonorous stimuli. The series of stimuli must continue until the memory of the traumatic event can be reprocessed adaptively, that is, without the emotional, negative or painful process associated with that memory.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in emotional balance | This will be evaluated by the Factorial Personality Battery before and after surgery | Postoperative (3 months, 12 months and 36 months after bariatric surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Weight loss | weight loss measured in percentage of weight loss (%WL) | Postoperative (3 months, 12 months and 36 months after bariatric surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMDR Therapy, Bariatric Surgery, Obesity