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ACTIVE NOT RECRUITING

NCT05820204

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

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-04-12

Completion Date

2026-09

Last Updated

2025-09-04

Healthy Volunteers

Conditions

Pain, Chronic Back Pain

Interventions

BEHAVIORAL

Pain reprocessing therapy (PRT)

A promising new psychotherapy for chronic pain

BEHAVIORAL

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

A psychotherapy for chronic pain that has 30+ years of research support.

OTHER

Usual care

Participants will be asked to continue to do whatever they are currently doing to manage their pain

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 last 2 years * Difficulty controlling bladder function (to screen out cauda equina syndrome) * Serious medical illness (e.g., current, or recent cancer diagnosis, severe cardiovascular disease) * Recent large unexplained, unintended weight loss (20lbs or more) * Recent vertebral fracture/ known spinal fractures or tumors * Known sensory/motor abnormalities in the trunk or legs. * Self-reported diagnosis of a specific inflammatory disorder: rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, or polymyositis

Locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States