Multidisciplinary Group Based Treatment of Patients With Chronic Pain. A Randomized Controlled Trial Comparing Acceptance Commitment Therapy and Treatment in a Primary Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Group difference in health related quality of life
研究概览
简要总结
The purpose of this study is to determine whether group based Acceptance and Commitment Therapy (ACT) at a university hospital clinic is superior to treatment in a primary care setting among patients with chronic pain.
Hypothesis:
i) A group based ACT treatment leads to less pain and greater Health Related Quality of Life (HRQOL) in patients with chronic pain than treatment in a primary care setting.
ii) The improvement in pain and HRQOL is mediated through an increased degree of pain willingness and involvement in activities.
iii) Improvement of pain and HRQOL after the two treatments is associated with demographic, psychosocial and somatic characteristics.
详细描述
Background:
Chronic pain represents a substantial social problem. In Norway, the prevalence of chronic moderate pain is between 25 and 30%, and for severe pain it is at 2%. Multidisciplinary treatment is recommended for chronic pain, and during the last years Acceptance Commitment Therapy (ACT) has been implemented.
Research design, methods and analyses:
One hundred and twenty participants will be recruited from a list of patients referred to the Multidisciplinary Pain Department at the University Hospital of North Norway. Those who meet the defined criteria, are invited to participate. The study has a randomized, semi-crossover design. The participants are allocated to group based ACT or treatment in a primary care setting with a gender stratified, block randomization with a ratio of 1: 1. This means that half of the participants (intervention group, n: 60) get early group based ACT, while the other half (control group, n: 60) will be treated in a primary health care setting. Those of the control group who still meet the criteria, will be offered ACT afterwards.
Data collection will take place at a) start of the study, b) a few days prior to the onset of ACT and c) a few days after ended ACT, and 6 months after the onset of ACT. Data collection is carried out with the same time intervals in the control group. After having received ACT data is collected 12 months after the onset of ACT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long-term pain condition over 6 months.
- •Strongest pain ≥ 4 on a scale of 0 to
- •Consent competent and over 18 years
- •Motivated for group-based psychological (ACT) treatment.
排除标准
- •Psychiatric illness and behavioral problems, including substance abuse that prevents good group interaction
- •Severe progressive disease
结局指标
主要结局
Group difference in health related quality of life
时间窗: 6 months after baseline
Health related quality of life is measured by Short Form-36 and analyzed by Mixed Model
Group difference in pain intensity
时间窗: 6 months after baseline
Continuous variable (Numeric rating scale) analyzed by Mixed Model
次要结局
- Change from baseline in pain willingness and involvement in activities(12 months after baseline)
- Group difference in drug consumption(6 months after baseline)
- Change from baseline in pain intensity(12 months after baseline)
- Change from baseline in health related quality of life(12 months after baseline)
- Group difference in consumption of health services(6 months after baseline)