Psychological Options for Wellness and Recovery (POWeR) Trial for Veterans With Chronic Back/Neck Pain
NCT ID: NCT07137715
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
360 participants
INTERVENTIONAL
2026-01-05
2028-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acceptability and Efficacy of Pain Reprocessing Therapy in Racially/ Ethnically Diverse Adults With Chronic Back Pain
NCT05820204
Single Session Pain Psychology Treatment: Comparative Efficacy & Mechanisms
NCT03167086
Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
NCT01794988
Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain
NCT01981798
Emotional Awareness and Expression Therapy (EAET) or Cognitive Behavior Therapy (CBT) for Older Veterans With Chronic Musculoskeletal Pain
NCT03844880
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Using advances in neuroscience and psychology, investigators recently developed a novel psychological treatment called 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 merely increase functioning.
In the first trial of PRT (N = 151), 66% of patients randomized to PRT were pain-free or nearly pain-free at post-treatment, compared to fewer than 20% of those in the placebo and usual care control groups. PRT has several critical conceptual distinctions from CBT including different approaches to pain subtyping, a different understanding of chronic pain etiology, differing treatment goals (recovery vs. improved functioning), and a different focus on non-pain psychosocial threats. Given the conceptual differences and early existing promising efficacy data of PRT, a critical next step to achieve practical improvements in Veteran health is a comparative effectiveness trial of PRT vs. CBT in a Veteran Affairs (VA) clinic, utilizing VA clinicians, VA treatment infrastructure, and Veteran participants.
Aim 1 of this study is to test the comparative effectiveness of PRT to CBT and usual care on pain severity (primary outcome) for veterans with CBNP at post-treatment (primary endpoint) and one year follow-up.
Aim 2 of this study is to test the comparative effectiveness of PRT to CBT and usual care on secondary patient-reported outcomes measuring core outcome domains, quality of life, and opioid medication use.
Aim 3 of this study is to identify key barriers and facilitators of PRT response in a Veteran population using qualitative methods in a subsample of participants (n = 40) and in clinicians learning PRT.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Pain reprocessing therapy (PRT)
A promising new psychotherapy for chronic pain
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.
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 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.
Usual Care
Participants will be asked to continue to do whatever they are currently doing to manage their pain.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Eastern Colorado Health Care System
FED
United States Department of Defense
FED
University of Colorado, Denver
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan K. Ashar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Joseph W. Frank, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
VA Eastern Colorado Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Eastern Colorado Health Care System
Aurora, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Charlotte Nolan, MPA
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HT9425-24-1-0915
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
24-2398
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.