Effects of EMDR Therapy in Patients With Severe Obesity Submitted to Bariatric Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change in emotional balance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Controlled Group
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 .
干预措施: Personality Factor Battery Test (PFB Test) (Behavioral)
EMDR Group
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.
干预措施: Eye Movement Desensitization and Reprocessing Therapy (EMDR) (Behavioral)
结局指标
主要结局
change in emotional balance
时间窗: Postoperative (3 months, 12 months and 36 months after bariatric surgery)
This will be evaluated by the Factorial Personality Battery before and after surgery
次要结局
- Total Weight loss(Postoperative (3 months, 12 months and 36 months after bariatric surgery))
研究者
Roberto de Cleva
Principal Investigator
University of Sao Paulo