Effectiveness of a Psychoeducation Program on Metabolic Syndrome, Cardiovascular Risk, Independency and Psychopatology in Patients With Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- weight
研究概览
简要总结
Patients with Severe Mental Disorder (SMD) show a life expectancy of 13 to 30 years lower than the general population. Among the factors that determine this expectancy are cardiovascular risk and the metabolic syndrome. The objective of the present study will be to evaluate the effectiveness of a rehabilitative intervention comprinsing a psychopharmacology and psychoeducation program on cardiovascular risk, metabolic syndrome, independency for activities of daily living and psychopathological symptoms.
详细描述
It will be selected sixty patients diagnosed with SMD from a community Mental Health Unit from Spain. It will be implemented a intervention program consisted of psychopharmacology + psychoeducation on healthy living habits during three months. The patients will be evaluated at the beginning, at three months and at six months follow-up for weight, waist circumference, waist-hip ratio, body mass index, cardiovascular risk, independency and psychopathology.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 40 years old,
- •A body mass index higher than 30
- •Psychopathologically stabilized
排除标准
- •Cognitive impairment
研究组 & 干预措施
Psychoeducation program
The intervention program consists of psychopharmacology (standard intervention in mental health services) + individual psychoeducation (individual treatment including learning of Healthy Lifestyle). This program is implemented for three months, allocated in several sessions.
干预措施: Psychoeducation program (Behavioral)
Habitual intervention
Intervention program consists of psychopharmacology (standard intervention in mental health services). This program is implemented for three months.
干预措施: Psychopharmacology intervention (Drug)
结局指标
主要结局
weight
时间窗: Change from Baseline in weight at 3 and 6 months
This measurement registers weight in Kg
次要结局
- PANNS(Change from Baseline in PANNS at 3 and 6 months)
- waist-hip ratio(Change from Baseline in waist-hip ratio at 3 and 6 months)
- waist circumference(Change from Baseline in waist circumference at 3 and 6 months)
- Global Assesment of funtioning Scale(Change from Baseline in Global Assesment of funtioning Scale at 3 and 6 months)
- Framingham scale(Change from Baseline in Framingham scale at 3 and 6 months)
研究者
José Manuel Pérez Mármol
Principal Investigator
Universidad de Granada