search
Back to results

Effects of EMDR Therapy in Patients With Severe Obesity

Primary Purpose

Obesity, Emotional Trauma

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Personality Factor Battery Test (PFB Test)
Eye Movement Desensitization and Reprocessing Therapy (EMDR)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring EMDR Therapy, Bariatric Surgery, Obesity

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital das Clinicas da Faculdade de Medicina da USPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Controlled Group

EMDR Group

Arm Description

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 .

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.

Outcomes

Primary Outcome Measures

change in emotional balance
This will be evaluated by the Factorial Personality Battery before and after surgery

Secondary Outcome Measures

Total Weight loss
weight loss measured in percentage of weight loss (%WL)

Full Information

First Posted
May 9, 2018
Last Updated
October 9, 2019
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03555110
Brief Title
Effects of EMDR Therapy in Patients With Severe Obesity
Official Title
Effects of EMDR Therapy in Patients With Severe Obesity Submitted to Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 2, 2018 (Actual)
Study Completion Date
June 2, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Emotional Trauma
Keywords
EMDR Therapy, Bariatric Surgery, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Controlled Group
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
EMDR Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personality Factor Battery Test (PFB Test)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing Therapy (EMDR)
Intervention Description
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 Measure Information:
Title
change in emotional balance
Description
This will be evaluated by the Factorial Personality Battery before and after surgery
Time Frame
Postoperative (3 months, 12 months and 36 months after bariatric surgery)
Secondary Outcome Measure Information:
Title
Total Weight loss
Description
weight loss measured in percentage of weight loss (%WL)
Time Frame
Postoperative (3 months, 12 months and 36 months after bariatric surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto de Cleva
Phone
55 11 999774502
Email
roberto.cleva@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Stipp
Phone
55 11 986206060
Email
vivistipp@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto De Cleva
Organizational Affiliation
Hospital das Clinicas da Faculdade de Medicina da USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da Faculdade de Medicina da USP
City
Sao Paulo
ZIP/Postal Code
05403900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto de Cleva
Phone
55 11 999774502
Email
roberto.cleva@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Vivian Stipp
Phone
55 11 986206060
Email
vivistipp@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The plan is to publish the complete data after the end of the study
Citations:
PubMed Identifier
17572308
Citation
Alvarez J, Pavao J, Baumrind N, Kimerling R. The relationship between child abuse and adult obesity among california women. Am J Prev Med. 2007 Jul;33(1):28-33. doi: 10.1016/j.amepre.2007.02.036.
Results Reference
background
PubMed Identifier
15761522
Citation
Cordas TA, Lopes Filho AP, Segal A. [Eating disorder and bariatric surgery: a case report]. Arq Bras Endocrinol Metabol. 2004 Aug;48(4):564-71. doi: 10.1590/s0004-27302004000400019. Epub 2005 Mar 7. Portuguese.
Results Reference
background
PubMed Identifier
9635069
Citation
Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
Results Reference
background
PubMed Identifier
18976880
Citation
Perkonigg A, Owashi T, Stein MB, Kirschbaum C, Wittchen H-U. Posttraumatic stress disorder and obesity: evidence for a risk association. Am J Prev Med. 2009 Jan;36(1):1-8. doi: 10.1016/j.amepre.2008.09.026. Epub 2008 Oct 31.
Results Reference
background
Citation
Shapiro, F. Dessensibilização e Reprocessamento Através de Movimentos Oculares: Princípios Básicos, Protocolos e Procedimentos. (2a. ed.) - Brasília: Nova Temática, 2007
Results Reference
background

Learn more about this trial

Effects of EMDR Therapy in Patients With Severe Obesity

We'll reach out to this number within 24 hrs