EFFects of EXPosure and Cognitive-behavioural Therapy for Chronic BACK Pain (NCT05294081) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
EFFects of EXPosure and Cognitive-behavioural Therapy for Chronic BACK Pain
Germany380 participantsStarted 2022-03-01
Plain-language summary
The overall aim of the present study is to compare two different psychological methods, Cognitive Behavioural Therapy (CBT) and Graduated Exposure in vivo (EXP) in the treatment of chronic back pain with regard to effectiveness and improvement of pain related disability.
Exploratory research will also be conducted to identify predictors of which patient groups benefit more from which method. This should optimise treatment options and create effective treatment offers for subgroups of pain patients.
Exposure therapy is an effective and economical treatment modality and was shown in a previous pilot study to be superior to CBT in reducing perceived movement limitation. CBT, on the other hand, appeared to be more effective in establishing coping strategies. With the help of the current study it should be possible to compare the effectiveness of both treatment methods and, in perspective, to identify those patient groups that benefit from exposure therapy and thus create a tailor-made treatment programme for subgroups of pain patients.
A total of 380 patients (age: ≥ 18) with chronic back pain and a sufficient degree of impairment will be included and analysed in the study.
Who can participate
Age range
18 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:
* Chronic low back pain (duration \> 6 months, pain on most days of the week)
* Sufficient level of disability, as defined by QBPDS ≥ 15 (Quebec Back Pain Disability Scale)
* Age 18 and above
* Agreeing to participate, verified by completion of informed consent
Exclusion Criteria:
* Back surgeries during the last six months or planned surgeries
* Red Flags
* inability to read or write in German
* pregnancy
* severe alcohol or drug addiction
* psychotic disorders
* another current psychological treatment
* physical inability to attend sessions
* parallel participation in another intervention study
Depression will be controlled for, medication will be required to stay stable until Follow-up and any changes will be controlled for, on-demand ("rescue") medication will be not allowed.
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
Change in pain related disability
Timeframe: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months after Posttest and 2 years after Posttest)