Effects of Stress-reducing Internet-based Cognitive Behavioral Therapy and Physiotherapy in Persons With Chronic Widespread Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 4
- 主要终点
- Pain spread
研究概览
简要总结
Objectives: To investigate the effect on pain of a stress reducing treatment that combine Internet based cognitive behavioral therapy (I-CBT) and physiotherapy in persons with chronic widespread pain (CWP) and to examine factors predicting potential improvement.
Methods: 200 persons with CWP will be recruited from different parts of Region Västra Götaland (VGR) in Sweden, and randomized into two groups.
Group 1: Combined intervention of stress reducing I-CBT and Physiotherapy. Group 2: Physiotherapy only.
The participants complete a battery of questionnaires of symptoms and health related aspects at baseline, 6, 12 and 24 months. Interventions will take place at local rehabilitation centers in VGR.
详细描述
The overall purpose of the study is to investigate the effect on pain of a stress-reducing treatment that combine Internet based cognitive behavioral therapy and physiotherapy, for persons with Chronic widespread pain.
Project description:
Design: A randomized controlled multicenter study, with two arms. Participants: 200 persons with CWP will be recruited to the randomized controlled study (RCT) in primary health care in VGR and by advertising social media and/or local newspapers.
Inclusion criteria:
- Women and men 18-65 years of age in VGR, fulfilling the criteria for CWP (ACR 1990).
- Sufficient knowledge of Swedish language
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men 18-70 years of age in VGR, fulfilling the criteria for CWP according to American College of Rheumatology 1990 criteria.
- •Sufficient knowledge of Swedish language
排除标准
- •Specific reasons for the pain, e g fracture or surgery in relation to the pain during the last 6 months.
- •Not having a smart phone or computer
- •Serious physical or psychological disease, such as Schizophrenia, stroke, ongoing cancer or other condition with restrictions of physical activity.
- •Score >15 on the subscale for anxiety or depression in the Hospital anxiety and depression scale (HADS): the participant will be advised to make an appointment with a psychologist.
研究组 & 干预措施
Intervention, group 1
Combined intervention of stress reducing I-CBT and physiotherapy.
干预措施: Internet-based cognitive behavioral therapy + physiotherapy (Behavioral)
Active control group, group 2
Physiotherapy only
干预措施: Physiotherapy only (Behavioral)
结局指标
主要结局
Pain spread
时间窗: Change from baseline to 6 months, 12 months and 24 months.
The participants will state their painful areas in a pain drawing with 18 predefined body areas. The score range from 0 to 18.
Pain intensity
时间窗: Change from baseline to 6 months, 12 months and 24 months.
The subscale for pain intensity included in the Fibromyalgia Impact Questionnaire (FIQ) is used. The subscale is a visual analogue scale (VAS) (0-100 mm) on which the participant rate their pain intensity during the previous week, ranging from 0 (No pain) to 100 (Very severe pain). The outcome is assessed both on group level as change in pain intensity over time between the groups and on an individual level as proportions of participants in each group who have achieved moderate (≥30%) and major (≥50%) change in pain intensity.
次要结局
- The Stress and Crisis Inventory (SCI-93)(Change from baseline to 6 months, 12 months and 24 months.)
- Fatigue(Change from baseline to 6 months, 12 months and 24 months.)
- The Leisure Time Physical Therapy Instrument (LTPAI)(Change from baseline to 6 months, 12 months and 24 months.)
- Research and development (RAND)-36(Change from baseline to 6 months, 12 months and 24 months.)
- The Hospital Anxiety and Depression Scale (HADS)(Change from baseline to 6 months, 12 months and 24 months.)
- Patient Global Impression of Change (PGIC)(Change from baseline to 6 months, 12 months and 24 months.)
研究者
Anna Bergenheim
Physiotherapist, PhD
Vastra Gotaland Region