Recruiting

PRT, CBT, Usual Care

Sponsor:

University of Colorado, Denver

Code:

NCT07137715

Conditions

Chronic Pain

Back Pain

Back Pain Lower Back Chronic

Neck Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pain reprocessing therapy (PRT)

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Usual Care

Study Details

Brief summary:

The goal of this clinical trial is to learn which treatment works better for veterans with chronic neck or back 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 main questions the study aims to answer are:

1. Which treatment works better for lowering pain: PRT, CBT, or usual care?
2. How do the effects of PRT compare with CBT and usual care in terms of pain relief and other factors such as emotional functioning, quality of life, anxiety, and pain medication use?

Participants will:

1. Be randomly assigned to receive either PRT, CBT, or usual care.
2. Complete questionnaires about their pain and health.
3. If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.

Conditions

Chronic Pain

Back Pain

Back Pain Lower Back Chronic

Neck Pain

Study ID

NCT07137715

Start date

Mar 27, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (18 and older)
  • Be veterans
  • Have a history of chronic back or neck pain defined as pain at least half the days of the last 6 months.
  • Have moderate or greater pain, defined as pain intensity ≥4 in the past week

Exclusion Criteria:

Clinical presentation suggestive of back pain that is secondary or peripheral in nature, including self-reported leg pain that is worse than back pain (indicative of radiculopathy or sciatica), spine surgery within the past 6 months, fall, motor vehicle accident or other trauma related to back pain in the past 6 months, back pain due to an inflammatory disorder, infection, or malignant etiology as determined per medical provider review, known sensory abnormality in trunk or legs, recent large (>20 lbs) unexplained weight loss, difficulty controlling bowels (to screen out cauda equina syndrome), and self-reported diagnoses of specific inflammatory disorders (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, and polymyositis).

Additionally, patients who meet any of the following criteria are ineligible due to anticipated difficulties complying with study procedures:

  • Moderate or severe cognitive impairment
  • Unstable or severe untreated mental health condition, including active suicidal ideation
  • Unstable or end-stage medical disease including active cancer
  • Back surgery planned within the next 6 months
  • Inability to communicate by telephone or video, including inability due to housing instability
  • Current pain-related litigation outside the VA (service connection-related applications are not excluded)
  • Having engaged in CBT or PRT for chronic pain in the past 6 months
  • Participants may be excluded based on the discretion of PIs Ashar and Frank

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pain reprocessing therapy (PRT)

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 weekly for approximately 9 weeks. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.

active comparator: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

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 9 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.

active comparator: Usual Care

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 9 weeks, the expected completion time of the PRT and CBT arms.

Interventions

Pain reprocessing therapy (PRT)

A promising new psychotherapy for chronic pain

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

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

Usual Care

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

Primary outcome measure

  • Pain intensity [ Time Frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization ]

Central Contacts and Locations

Central contacts

Jonathan K Ashar, PhD

303.724.2536yoni.ashar.@cuanschutz.edu

Locations

VA Eastern Colorado Health Care System

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Joseph W. Frank, MD, MPH

More Information

Sponsor

University of Colorado, Denver

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • Pain Reprocessing Therapy (PRT)
  • PRT
  • Chronic Pain
  • Veterans
  • Neck Pain
  • Back Pain
  • Cognitive Behavioral Therapy (CBT)
  • CBT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-03-31.