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Effects of EMDR Therapy in Patients With Severe Obesity

U

University of Sao Paulo General Hospital

Status

Unknown

Conditions

Obesity
Emotional Trauma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03555110
78695317.3.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

30 to 55 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Controlled Group
Active Comparator group
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 .
Treatment:
Behavioral: Personality Factor Battery Test (PFB Test)
EMDR Group
Active Comparator group
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.
Treatment:
Behavioral: Eye Movement Desensitization and Reprocessing Therapy (EMDR)

Trial contacts and locations

1

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Central trial contact

Vivian Stipp; Roberto de Cleva

Data sourced from clinicaltrials.gov

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