Clinical trial NCT03555110: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Emotional Trauma
Keywords: EMDR Therapy
Bariatric Surgery
Obesity
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in emotional balance
timeFrame: Postoperative (3 months, 12 months and 36 months after bariatric surgery)
Secondary outcomes:
measure: Total Weight loss
timeFrame: Postoperative (3 months, 12 months and 36 months after bariatric surgery)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da USP
Study officials:
affiliation: Hospital das Clinicas da Faculdade de Medicina da USP
name: Roberto De Cleva
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: Shapiro, F. Dessensibilização e Reprocessamento Através de Movimentos Oculares: Princípios Básicos, Protocolos e Procedimentos. (2a. ed.) - Brasília: Nova Temática, 2007