An interventional study of Pain reprocessing therapy (PRT) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in Pain, Chronic and Back Pain, sponsored by Weill Medical College of Cornell University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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:
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.
Investigators recently developed a novel psychological treatment, pain reprocessing therapy (PRT). Using a combination of cognitive, exposure-based, and somatic psychotherapy techniques, PRT aims to promote patients' reconceptualization of pain as due to reversible, non-dangerous brain activity rather than peripheral pathology. Critically, PRT aims to reduce or eliminate pain, rather than increasing functioning.
In the first trial of PRT (N = 151), 66% of patients randomized to PRT were pain-free or nearly so at post-treatment, as compared to fewer than 20% of placebo and usual care controls. This trial was conducted in a primarily White, highly-educated population with face-to-face treatment, and how PRT effects would generalize to a more diverse population or to telehealth treatment is not known.
PRT was developed to better address pain intensity and pain-related outcomes compared to leading psychological treatments for pain such as cognitive behavioral therapy (CBT). This study aims to yield preliminary findings on the comparative efficacy of PRT vs. CBT vs. usual care. Developing scalable effective, non-pharmacological chronic pain treatments and testing their efficacy in racial/ethnic minorities is an urgent societal need. Accordingly, this study also tests a remotely-delivered PRT intervention in a diverse patient population.
Aim 1 of this study is to test the feasibility (recruitment \& retention) of conducting a randomized clinical trial comparing remotely-delivered PRT with an active comparator, CBT, and usual care and to assess the acceptability (helpfulness, satisfaction, \& impact) of PRT in a diverse, lower socioeconomic status (SES) patient population.
Aim 2 of this study is to test the comparative efficacy of PRT vs. CBT and PRT vs. usual care on pain intensity and other pain-related outcomes.
Additional resources became available during the study, allowing an increase in sample size from N = 75 to N = 150 to provide greater statistical power aim 2 (comparative efficacy). No interim analyses were conducted at any point, and investigators remained blind to study outcomes. The decision to expand the sample size was made after careful deliberation with Columbia and Cornell Roybal Center Advisory Committees.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Instability in living conditions or major interfering life events:
PRT has 5 components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend 1 assessment and education telehealth session with a physician followed by 8, 50-minute, therapist-led sessions. Pacing will be flexible, ranging from 5-12 weeks, to increase accessibility. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.
Behavioral: Pain reprocessing therapy (PRT)
CBT-CP, considered the leading psychological treatment for chronic pain, is a structured, time-limited intervention that aims to teach patients how to better manage chronic pain and improve their quality of life. Participants will receive 9, 50-minute sessions of CBT-CP over 5 - 12 weeks. The VA CBT-CP protocol contains an initial orientation involving education and familiarization with the CBT-CP approach to chronic pain. The protocol then includes sessions that focus on topics such as exercise, relaxation, pleasant activities, cognitive coping, and sleep. All CBT-CP sessions will be remotely-delivered.
Behavioral: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Participants will be asked to continue whatever they are already doing to care for their back pain. Length of the usual care condition will be 5 weeks, the expected mean completion time of the PRT and CBT arms, and may be adjusted at mid-enrollment to match treatment arm length more closely.
Other: Usual care
A promising new psychotherapy for chronic pain
A psychotherapy for chronic pain that has 30+ years of research support.
Also known as: Cognitive Behavioral Therapy
Participants will be asked to continue to do whatever they are currently doing to manage their pain
Also known as: Treatment as usual
Pain intensity
Last-week average pain intensity is assessed via the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF assess pain severity and its impact on functioning. It consists of 9 total items including 4 pain items and 5 pain interference items. The 4 pain items measure pain in the last week on a numerical rating scale of 0 (no pain at all) to 10 (pain as bad as you can imagine).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Session Attendance
Session attendance is a feasibility measure calculated as the proportion or percentage of people randomized to either PRT or CBT who attended at least 6 sessions.
Time frame: This value will be calculated a day after post-treatment for the last participant, approximately 1 year from the start of enrollment
Pain interference
Pain interference is assessed via the pain interference items (5-items) of the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF assess pain severity and its impact on functioning. It consists of 9 total items including 4 pain items and 5 pain interference items. The 5 pain interference items measure pain interference in the last week on a numerical rating scale of 0 (does not interfere) to 10 (completely interferes).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Depression
Depression is assessed via the 8-item depression sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF). The PROMIS scale as a whole monitors the physical, mental, and social health of adults and children. Each item in the PROMIS-SF depression sub-scale is rated on a 5-point scale of 1 (never) to 5 (always).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Positive Affect
Assessed via the PANAS is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Anxiety
Anxiety is assessed via the 8-item anxiety sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF). The PROMIS scale as a whole monitors the physical, mental, and social health of adults and children. Each item in the PROMIS-SF anxiety sub-scale is rated on a 5-point scale of 1 (never) to 5 (always).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Anger
Anger is assessed via the 5-item anger sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF). The PROMIS scale as a whole monitors the physical, mental, and social health of adults and children. Each item in the PROMIS-SF anger sub-scale is rated on a 5-point scale of 1 (never) to 5 (always).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Sleep quality
Sleep quality is assessed via the 8-item sleep disturbance sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF). The PROMIS scale as a whole monitors the physical, mental, and social health of adults and children. 7 of the 8 items in the PROMIS-SF sleep disturbance sub-scale are rated on a 5-point scale of 1 (not at all) to 5 (very much) while 1 item is rated on a 5-point scale of 1 (very poor) to 5 (very good).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Client satisfaction
Client Satisfaction is assessed the Patients' Global Impression of Change (PGIC). The PGIC is a single-item self-report scale that measures a patient's belief about the efficacy of treatment. The single-item is rated on a 7-point scale of 1 (No change or condition has got worse) to 7 (a great deal better).
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Physical Activity Levels
Physical activity levels are assessed via the 7-item, self-reported International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF measures sitting times as well as physical activity and their intensities as performed by a participant during the last 7 days. Types of physical activities and their intensities are recorded in time (Hours per day: minutes per day)
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Medication Use
Medication use is assessed by asking participants to provide the names, dosages, and frequencies of the medications that they are currently taking for pain management only.
Time frame: Primary time point is the day after post-treatment, 1.5 months on average
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Investigators will share de-identified project data publicly under Data Use Agreements that safeguard individual participant confidentiality and privacy. The study will produce the following types of data. All data will be available for sharing, except where noted, upon the date of the online publication of the results of the primary study aims: * Patient-reported outcomes: All patient-reported outcomes will be de-identified and shared in raw form. * Measures of treatment engagement: Deidentified values (e.g. number of treatment sessions attended) will be shared in raw form. * Audio-video recordings of therapy sessions: These will be used in planned future research. Upon publication of a manuscript referencing these data, deidentified subject-level summary statistics (e.g., metrics of patient-provider vocal synchrony) will be shared.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University