Psychological Options for Wellness and Recovery (POWeR) Trial for Veterans With Chronic Back/Neck Pain

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07137715
Status
Recruiting
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Conditions

  • Back Pain
  • Back Pain Lower Back Chronic
  • Chronic Pain
  • Neck Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pain reprocessing therapy (PRT) — BEHAVIORAL
    A promising new psychotherapy for chronic pain
  • Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) — BEHAVIORAL
    A psychotherapy for chronic pain that has 30+ years of research support.
  • Usual Care — OTHER
    Participants will be asked to continue to do whatever they are currently doing to manage their pain.

Study Details

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.

Key Dates

Start date
Mar 27, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Eastern Colorado Health Care SystemAuroraColorado80045
Charlotte Nolan, MPA
Joseph W. Frank, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
VA Eastern Colorado Health Care System· Aurora, CO

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