Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults Wi… (NCT05820204) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
United States150 participantsStarted 2023-04-12
Plain-language summary
The goal of this clinical trial is to learn which treatment works better for adults with chronic pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain).
The study's main questions are:
* Does PRT work well for adults with chronic pain?
* Which treatment works better for lowering pain: PRT, CBT, or usual care?
This study will compare PRT, CBT, and usual care to see which is most helpful for lowering pain and helping with other problems that people with chronic pain can have.
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:
* Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session)
* Back pain that is an ongoing problem for at least half the days of the last 6 months
* Back pain that is worse than leg pain.
Exclusion Criteria:
* Current litigation or compensation associated with pain or plans to apply for compensation or engage in litigation in the next 6 months
* Active suicidal ideation with intent, recent history of suicide attempt, or recent history of suicide attempts or self-harm behaviors within the past 5 years (including non-suicidal self-harm)
* Recent history of inpatient psychiatric hospitalization within the past 5 years
* Active, current psychosis or mania
* Active, current substance abuse, or problems with substance abuse within the past 2 years
* Instability in living conditions or major interfering life events:
* Major surgery or other major medical event planned in coming six months
* Unsure whether will reliably have suitable conditions for telehealth appointments over the next two months, including a computer or tablet, reliable fast internet, and a quiet comfortable room that is reliably available.
* Major, interfering changes in employment or housing anticipated over the next six months
* Failure to complete at least 85% (6 of 7) of EMA surveys in the first week of the study (post-consent, pre-randomization)
* Leg pain worse than back pain
* Back surgery within the la…
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: Primary time point is the day after post-treatment, 1.5 months on average
2
Session Attendance
Timeframe: This value will be calculated a day after post-treatment for the last participant, approximately 1 year from the start of enrollment
Trial details
NCT IDNCT05820204
SponsorWeill Medical College of Cornell University