NCT03555110

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2020

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

May 9, 2018

Last Update Submit

October 9, 2019

Conditions

ObesityEmotional Trauma

Keywords

EMDR TherapyBariatric SurgeryObesity

Outcome Measures

Primary Outcomes (1)

  • change in emotional balance

    This will be evaluated by the Factorial Personality Battery before and after surgery

    Postoperative (3 months, 12 months and 36 months after bariatric surgery)

Secondary Outcomes (1)

  • Total Weight loss

    Postoperative (3 months, 12 months and 36 months after bariatric surgery)

Study Arms (2)

Controlled Group

ACTIVE COMPARATOR

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)

EMDR Group

ACTIVE COMPARATOR

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)

Interventions

Personality Factor Battery Test (PFB Test)BEHAVIORAL

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.

Controlled Group
Eye Movement Desensitization and Reprocessing Therapy (EMDR)BEHAVIORAL

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.

EMDR Group

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da USP

São Paulo, 05403900, Brazil

RECRUITING

Related Publications (5)

  • 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.

    PMID: 17572308BACKGROUND

  • 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.

    PMID: 15761522BACKGROUND

  • 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.

    PMID: 9635069BACKGROUND

  • 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.

    PMID: 18976880BACKGROUND

  • Shapiro, F. Dessensibilização e Reprocessamento Através de Movimentos Oculares: Princípios Básicos, Protocolos e Procedimentos. (2a. ed.) - Brasília: Nova Temática, 2007

    BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roberto De Cleva

    Hospital das Clinicas da Faculdade de Medicina da USP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto de Cleva

CONTACT

55 11 999774502roberto.cleva@hc.fm.usp.br

Vivian Stipp

CONTACT

55 11 986206060vivistipp@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 13, 2018

Study Start

February 1, 2018

Primary Completion

June 2, 2018

Study Completion

June 2, 2020

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

The plan is to publish the complete data after the end of the study

Locations

BR(1)