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Trial record 4 of 272 for:    personality AND therapy | Recruiting, Not yet recruiting, Available Studies

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
Sponsor:
Information provided by (Responsible Party):
Roberto de Cleva, University of Sao Paulo

Brief Summary:
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.

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:

  • 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)
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Roberto de Cleva 55 11 999774502 roberto.cleva@hc.fm.usp.br
Contact: Vivian Stipp 55 11 986206060 vivistipp@hotmail.com

Locations
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Brazil
Hospital das Clinicas da Faculdade de Medicina da USP Recruiting
Sao Paulo, Brazil, 05403900
Contact: Roberto de Cleva    55 11 999774502    roberto.cleva@hc.fm.usp.br   
Contact: Vivian Stipp    55 11 986206060    vivistipp@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Roberto De Cleva Hospital das Clinicas da Faculdade de Medicina da USP

Publications:
Perkonigg, A.; Owashi T.; Stein, M.; Kirschbaum, C.; Wittchen, H. Posttraumatic Stress Disorder and Obesity: Evidence for a Risk Association, v. 36, n. 1, p. 1-8, jan/ 2009. Disponível em: http://www.ajpmonline.org. Acesso em 15 maio 2015
Shapiro, F. Dessensibilização e Reprocessamento Através de Movimentos Oculares: Princípios Básicos, Protocolos e Procedimentos. (2a. ed.) - Brasília: Nova Temática, 2007

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Responsible Party: Roberto de Cleva, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03555110     History of Changes
Other Study ID Numbers: 78695317.3.0000.0068
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The plan is to publish the complete data after the end of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roberto de Cleva, University of Sao Paulo:
EMDR Therapy
Bariatric Surgery
Obesity

Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms