NCT07137715

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. 1.Which treatment works better for lowering pain: PRT, CBT, or usual care?
  2. 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?
  3. 3.Be randomly assigned to receive either PRT, CBT, or usual care.
  4. 4.Complete questionnaires about their pain and health.
  5. 5.If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
29mo left

Started Mar 2026

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

August 11, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

March 27, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

August 11, 2025

Last Update Submit

March 30, 2026

Conditions

Chronic PainBack PainBack Pain Lower Back ChronicNeck Pain

Keywords

Pain Reprocessing Therapy (PRT)PRTChronic PainVeteransNeck PainBack PainCognitive Behavioral Therapy (CBT)CBT

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Last-week average pain intensity is assessed via 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 intensity items and 5 pain interference items. The 4 pain intensity 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).

    Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization

Secondary Outcomes (8)

  • Pain Interference

    Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization

  • Satisfaction with Life

    Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization

  • Depression

    Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization

  • Anxiety

    Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization

  • Fatigue

    Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization

  • +3 more secondary outcomes

Study Arms (3)

Pain reprocessing therapy (PRT)

EXPERIMENTAL

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.

Behavioral: Pain reprocessing therapy (PRT)

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

ACTIVE COMPARATOR

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.

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

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care

Interventions

Pain reprocessing therapy (PRT)BEHAVIORAL

A promising new psychotherapy for chronic pain

Pain reprocessing therapy (PRT)
Usual CareOTHER

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

Also known as: Treatment as usual
Usual Care
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)BEHAVIORAL

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

Also known as: Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Colorado Health Care System

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Chronic PainBack PainNeck Pain

Interventions

Cognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jonathan K. Ashar, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Joseph W. Frank, MD, MPH

    VA Eastern Colorado Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan K Ashar, PhD

CONTACT

303.724.2536yoni.ashar.@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment will be completed via automated transmission of a REDCap link, and as such is inherently blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three-arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 22, 2025

Study Start

March 27, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data sharing procedures have not been finalized. At a minimum, a complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses of the study will be created and made available within one year after the completion of the study, pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Depending on feasibility and guidance from VA Office of Research Oversight, a Limited Dataset (LDS) may be created and shared. We have not yet determined how to operationalize data sharing for this study. In the interim, contact the PI for questions or requests.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

US(1)