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临床试验/NCT03937167
NCT03937167已完成不适用

Benefits of a Psychotherapy Group Program as Oppossed to the Standard Method in the Treatment of Obesity. A Randomized Controlled Trial.

Hospital Universitario Infanta Leonor1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
180
试验地点
1
主要终点
weight difference

研究概览

简要总结

Obesity has reached pandemic proportions in recent years, affecting not only the physical health, but also the mental health, of obese people. According to Spain's National Health Survey 2011-12, the prevalence of obesity in the adult population of Spain was 17%, having increased by 2.5% since 2006. Therefore, a constant and worrying increase in the prevalence of obesity is being observed, which is having a great impact, both individually, in terms of health and quality of life, and socially, inter alia, by raising health expenditure due to increased morbidity.

In this context, the desirability of a comprehensive approach that includes psychological intervention in attending obese patients (Rev Cochrane, 2006), has been given greater prominence. Paying attention to the emotional and psychopathological aspects related to obesity has proven to be an action that could have positive impact on obesity intervention models.

The aim of this project is to measure, through a clinical trial, the efficacy of a psychotherapy group program for obesity patients who are attended by the consulting endocrinologist at the Infanta Leonor Hospital (Madrid). The impact of body mass index, psychological wellbeing, psychopathology and quality of life of two experimental study groups will be compared, one a control group of patients that follows the standard treatment, the other an experimental group that follows not only the standard treatment, but also the psychotherapy group intervention program.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age older than 18 and younger than
  • •Body mass index of 30 or higher.
  • •Candidate to a specific obesity treatment.
  • •Accept psychological attention.
  • •Able to understand and consent participation.
  • •Able to speak, write and read in Spanish.
  • •Committed to assist weekly for 6 months
  • •Non-inclusion Criteria:
  • •Obesity related to a non- stabilized hormonal disorder.
  • •Severe mental disorders requiring specific treatment resources.
  • •Cognitive or sensitive deficits.
  • •Having had bariatric surgery within last 2 years.

排除标准

  • •Pregnancy during treatment
  • •Bariatric surgery during treatment
  • •Addictive disorder as a principal diagnosis.

研究组 & 干预措施

Control

No Intervention

Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry

Completers

Experimental

Randomized to treatment AND complete treatment 14 sessions are needed

干预措施: Psychotherapy group (Other)

Drop-out

No Intervention

Randomized to treatment BUT do not assist or do not complete treatment Less than 14 sessions

结局指标

主要结局

weight difference

时间窗: 1 year

Difference between the initial and final weight in kilograms

次要结局

  • Eating disorder risk (EDRC)(1 Year)
  • Physical quality of life(1 year)
  • Motivation to change(1 year)
  • Positive Symptom Distress Index (PSDI)(1 year)
  • Positive Symptom Total (PST).(1 year)
  • Global Severity Index (GSI)(1 year)
  • Mental quality of life(1 year)
  • Mediterranean Diet Adherence(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Quintero

Psychiatry Department Head

Hospital Universitario Infanta Leonor

研究点 (1)

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