Internet-based Cognitive Behavioral Therapy and Physiotherapy in Persons With Chronic Widespread … (NCT04624139) | Clinical Trial Compass
CompletedNot Applicable
Internet-based Cognitive Behavioral Therapy and Physiotherapy in Persons With Chronic Widespread Pain
Sweden129 participantsStarted 2020-11-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity
Timeframe: Change from baseline to 6 months, 12 months and 24 months.
2
Pain spread
Timeframe: Change from baseline to 6 months, 12 months and 24 months.