Benefits of a Psychotherapy Group Program as Oppossed to the Standard Method in the Treatment of Obesity. A Randomized Controlled Trial.
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
Standard treatment at Hospital Infanta Leonor with Endocrinology and Psyquiatry
Completers
Randomized to treatment AND complete treatment 14 sessions are needed
干预措施: Psychotherapy group (Other)
Drop-out
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
Javier Quintero
Psychiatry Department Head
Hospital Universitario Infanta Leonor
