Effects of EMDR Therapy in Patients With Severe Obesity

Obesity Clinical Trial

Official title:

Effects of EMDR Therapy in Patients With Severe Obesity Submitted to Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03555110
• Other study ID #: 78695317.3.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: June 2, 2020

Study information

• Verified date: October 2019
• Source: University of Sao Paulo General Hospital
• Contact: Roberto de Cleva
• Phone: 55 11 999774502
• Email: roberto.cleva[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2, 2020
• Est. primary completion date: June 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Trauma
• Obesity
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da USP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Cordás TA, Lopes Filho AP, Segal A. [Eating disorder and bariatric surgery: a case report]. Arq Bras Endocrinol Metabol. 2004 Aug;48(4):564-71. Epub 2005 Mar 7. Review. Portuguese. — View 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. — View Citation

Perkonigg, A.; Owashi T.; Stein, M.; Kirschbaum, C.; Wittchen, H. Posttraumatic Stress Disorder and Obesity: Evidence for a Risk Association, v. 36, n. 1, p. 1-8, jan/ 2009. Disponível em: http://www.ajpmonline.org. Acesso em 15 maio 2015

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Weight loss	weight loss measured in percentage of weight loss (%WL)	Postoperative (3 months, 12 months and 36 months after bariatric surgery)