Effects of EMDR Therapy in Patients With Severe Obesity

Not Applicable

• Conditions: Emotional Trauma; Obesity
• Interventions: Behavioral: Personality Factor Battery Test (PFB Test); Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR)

• Registration Number: NCT03555110
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-05-09
• Primary Completion: 2018-06-02
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-10
• Study Completion: 2020-06-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controlled Group	Personality Factor Battery Test (PFB Test)	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 .
EMDR Group	Eye Movement Desensitization and Reprocessing Therapy (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.

Primary Outcome Measures

Name	Time	Method
change in emotional balance	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

Name	Time	Method
Total Weight loss	Postoperative (3 months, 12 months and 36 months after bariatric surgery)	weight loss measured in percentage of weight loss (%WL)

Trial Locations

Locations (1)

Hospital das Clinicas da Faculdade de Medicina da USP; 🇧🇷 Sao Paulo, Brazil