Effects of EMDR Therapy in Patients With Severe Obesity
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|ClinicalTrials.gov Identifier: NCT03555110|
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Emotional Trauma||Behavioral: Personality Factor Battery Test (PFB Test) Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Effects of EMDR Therapy in Patients With Severe Obesity Submitted to Bariatric Surgery|
|Actual Study Start Date :||February 1, 2018|
|Actual Primary Completion Date :||June 2, 2018|
|Estimated Study Completion Date :||June 2, 2020|
Active Comparator: Controlled Group
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)
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.
Active Comparator: EMDR Group
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:
Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR)
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.
- change in emotional balance [ Time Frame: Postoperative (3 months, 12 months and 36 months after bariatric surgery) ]This will be evaluated by the Factorial Personality Battery before and after surgery
- Total Weight loss [ Time Frame: Postoperative (3 months, 12 months and 36 months after bariatric surgery) ]weight loss measured in percentage of weight loss (%WL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555110
|Contact: Roberto de Cleva||55 11 firstname.lastname@example.org|
|Contact: Vivian Stipp||55 11 email@example.com|
|Hospital das Clinicas da Faculdade de Medicina da USP||Recruiting|
|Sao Paulo, Brazil, 05403900|
|Contact: Roberto de Cleva 55 11 999774502 firstname.lastname@example.org|
|Contact: Vivian Stipp 55 11 986206060 email@example.com|
|Principal Investigator:||Roberto De Cleva||Hospital das Clinicas da Faculdade de Medicina da USP|