Efectiveness of a Cognitive Behavioral Intervention in Patients With Symptoms Somatization, as Measure Quality of Life, Front the Clinical Practice Usual Action in Primary Health Care. A Controlled Clinical Trial With Parallel Groups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Perceived quality of life
研究概览
简要总结
The purpose of this study is to evaluate the efectiveness of a behavioral cognitive grupal intervention (BCI) in patients with somatization symptoms which has an effect on the perceived quality of life front conventional intervention.
详细描述
Aim: to determine whether a cognitive-behavioral group intervention in patients with unexplicated somatic symptoms, that have come to the primary care medical in Madrid, is more effective than normal practice in terms of improving life quality at one year.
Method:
Design:cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. unit of randomization are centres.Analysis unit: patients between 18 and 65 years old.
Intervention: The cognitive behavioral grupal Terapy in the internention group and the usual intervention in the control group.
Sample size adjusted for design effect=242 (121 in each arm). Main response variable: preceived quality of life (SF-12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Attending patients with 2 or more medically unexplained somatic symptoms during the last 6 months.
- •Having came to medical examination on primary care at least 10 times during the last year.
- •be able to follow the trial´s demands, not have plans for moving another place and understand the Spanish language.
- •Patients who consent to take part.
排除标准
- •Diagnostics on serious mental disorder.
- •Suicidal intentions at the moment of getting involved in the study.
- •Diagnostics on addiction to toxic substances.
- •Diagnostics on well-known body illness responsible for the symptoms.
- •Previous psychotherapy during the previous year.
研究组 & 干预措施
Experimental Group
Intervention group: Structured nursing intervention
干预措施: Cognitive Behavioral Therapy (Behavioral)
No intervention
Control group: conventional intervention or non_support
结局指标
主要结局
Perceived quality of life
时间窗: Change from baseline in quality of life at 12 months after the intervention
Perceived quality of life: Quality of life measured by SF-12 questionnare on Mental Healthcare Change from baseline in quality of life at 3, 6 and 12 months after the intervention.
次要结局
- Number of examinations(Number of examinations from baseline until 12 months after the intervention)
- Temporary labor disability (TLD)(Days on TLD from baseline until 12 months after the intervention)
- Questionnarie on Global Clinical Impression(Change from baseline in patient and doctor´s perception at 12 months afer the intervention)
- Prescribed medicine(Prescribed medicine from baseline until 12 months after the intervention)
研究者
Esperanza Escortell
Epidemiologist
Gerencia de Atención Primaria, Madrid