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Pain, ChronicNCT05820204

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

A study testing Pain reprocessing therapy (PRT) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in people with Pain, Chronic and Back Pain, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Chronic, Back Pain
What is being tested?
Pain reprocessing therapy (PRT) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteUnited States
Study dates
12 Apr 2023to 19 Aug 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Pain reprocessing therapy (PRT), Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), Usual care
Keywords
chronic pain, Pain Reprocessing Therapy, Cognitive Behavioral Therapy for Chronic Pain
Medical subject headings
Chronic Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain reprocessing therapy (PRT)Behavioural

    A promising new psychotherapy for chronic pain

  • Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Behavioural

    Also called Cognitive Behavioral Therapy

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

  • Usual careOther

    Also called Treatment as usual

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

Study groups in NCT05820204
Study groupRoleWhat they receive
Pain reprocessing therapy (PRT)ExperimentalPRT 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.
Receives: Behavioral: Pain reprocessing therapy (PRT)
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Active comparatorCBT-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.
Receives: Behavioral: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
Usual CareActive comparatorParticipants 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.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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). The reported score is the mean of the 4 pain items, yielding a total range of 0-10, with higher scores indicating greater pain severity.

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  2. Session Attendance

    Session attendance is a feasibility measure calculated as the percentage of people randomized to either PRT or CBT who attended at least 6 sessions.

    Measured: Assessed the day after post-treatment, an average of 1.5 months after randomization.

Secondary outcomes (8)
  1. Pain Interference

    Pain interference is assessed via the 5 pain interference items of the Brief Pain Inventory Short Form (BPI-SF). The BPI-SF assesses 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). The reported score is the mean of the 5 pain interference items, yielding a total range of 0-10, with higher scores indicating greater pain interference.

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  2. Depression

    Depression is assessed via the 8-item depression sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF), rated on a 5-point scale of 1 (never) to 5 (always). Raw scores (range 8-40) are converted to a T-score (mean 50, SD 10, U.S. general population norm); T-scores for this form range from 38.2 to 81.3, with higher scores indicating greater depressive symptoms.

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  3. Positive Affect

    Positive affect is assessed via the 5-item Positive Affect subscale (Attentive, Active, Alert, Inspired, Determined), asking respondents to indicate the extent to which each word describes how they felt in the past week. Each item is rated on a 5-point scale of 1 (very slightly or not at all) to 5 (extremely). Scores are summed across the 5 items, yielding a possible range of 5 to 25. A score of 5 indicates the lowest possible level of positive affect; a score of 25 indicates the highest possible level of positive affect.

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  4. Anxiety

    Anxiety is assessed via the 8-item anxiety sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF), rated on a 5-point scale of 1 (never) to 5 (always). Raw scores (range 8-40) are converted to a T-score (mean 50, SD 10, U.S. general population norm); T-scores for this form range from 37.1 to 83.1, with higher scores indicating greater anxiety.

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  5. Anger

    Anger is assessed via the 5-item anger sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF), rated on a 5-point scale of 1 (never) to 5 (always). Raw scores (range 5-25) are converted to a T-score (mean 50, SD 10, U.S. general population norm); T-scores for this form range from 32.9 to 82.9, with higher scores indicating greater anger.

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  6. Sleep Disturbance

    Sleep disturbance is assessed via the 8-item sleep disturbance sub-scale of the Patient Reported Outcome Measurement Information System Short Form (PROMIS-SF), rated on 5-point item-specific scales. Raw scores (range 8-40) are converted to a T-score (mean 50, SD 10, U.S. general population norm); T-scores for this form range from 30.5 to 77.5, with higher scores indicating greater sleep disturbance.

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  7. 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 0 (No change or condition has got worse) to 6 (a great deal better).

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

  8. Change in Pain 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. A blinded research assistant reviewed pre- and post-treatment responses and manually coded each participant as increasing, decreasing, or no change with regards to overall pain medication burden (number of pain medications, dose, frequency, and class: opioid > prescription > OTC). Cases with insufficient or unreliable data were excluded (e.g., a participant with multiple medications reported at baseline but none at post-treatment, suggestive of missing data).

    Measured: Primary time point is the day after post-treatment, 1.5 months on average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start12 Apr 2023
  3. Primary completion25 Aug 2025
  4. Study completion19 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three-arm randomized control trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820204
Sponsor's protocol ID
22-2162
Other IDs
P30AG022845
Status last verified
Oct 2026
First submitted
16 Mar 2023
Last updated
27 Oct 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Pain reprocessing therapy (PRT) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in people with Pain, Chronic and Back Pain, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: Primary time point is the day after post-treatment, 1.5 months on average). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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