ACTIVE_NOT_RECRUITING

Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility and Acceptability of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain

Quick Facts

Study Start:2023-04-12
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05820204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Last-week average back pain of at least 4 of 10 at the two pretreatment timepoints (online pre-screening and informed consent session)
  2. * Back pain that is an ongoing problem for at least half the days of the last 6 months
  3. * Back pain that is worse than leg pain.
  1. * Current litigation or compensation associated with pain or plans to apply for compensation or engage in litigation in the next 6 months
  2. * 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)
  3. * Recent history of inpatient psychiatric hospitalization within the past 5 years
  4. * Active, current psychosis or mania
  5. * Active, current substance abuse, or problems with substance abuse within the past 2 years
  6. * Instability in living conditions or major interfering life events:
  7. * Major surgery or other major medical event planned in coming six months
  8. * 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.
  9. * Major, interfering changes in employment or housing anticipated over the next six months
  10. * Failure to complete at least 85% (6 of 7) of EMA surveys in the first week of the study (post-consent, pre-randomization)
  11. * Leg pain worse than back pain
  12. * Back surgery within the last 2 years
  13. * Difficulty controlling bladder function (to screen out cauda equina syndrome)
  14. * Serious medical illness (e.g., current, or recent cancer diagnosis, severe cardiovascular disease)
  15. * Recent large unexplained, unintended weight loss (20lbs or more)
  16. * Recent vertebral fracture/ known spinal fractures or tumors
  17. * Known sensory/motor abnormalities in the trunk or legs.
  18. * Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis

Contacts and Locations

Principal Investigator

Jonathan K. Ashar, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Jonathan K. Ashar, Ph.D., PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-12
Study Completion Date2025-07

Study Record Updates

Study Start Date2023-04-12
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • chronic pain
  • Pain Reprocessing Therapy
  • Cognitive Behavioral Therapy for Chronic Pain

Additional Relevant MeSH Terms

  • Pain, Chronic
  • Back Pain