Chronic PainPOWeRNCT07137715
Psychological Options for Wellness and Recovery (POWeR) Trial for Veterans With Chronic Back/Neck Pain
A study testing Pain reprocessing therapy (PRT) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) in people with Chronic Pain and Back Pain, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Back Pain, Back Pain Lower Back Chronic
- What is being tested?
- Pain reprocessing therapy (PRT) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Eastern Colorado Health Care System
Aurora, Colorado, 80045
Charlotte Nolan, MPA
Joseph W. Frank, MD, MPH
About this study
Official title: Pain Reprocessing Therapy for Veterans With Chronic Back Pain: Comparative Efficacy and Facilitators and Barriers to Implementation
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:
Read more
- Which treatment works better for lowering pain: PRT, CBT, or usual care?
- 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:
- Be randomly assigned to receive either PRT, CBT, or usual care.
- Complete questionnaires about their pain and health.
- If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.
Read the detailed description
The current leading psychotherapeutic treatment for chronic pain is cognitive behavioral therapy (CBT-CP), which has been found to be safe and modestly efficacious in the treatment of chronic back or neck pain (CBNP). The fundamental goal of CBT-CP is to encourage participants to adopt an active, problem-solving approach to managing the challenges associated with chronic pain. CBT-CP intervention follows a standard structure of 9 sessions with the following objectives: 1) reducing the negative impact of pain on daily life 2) improving physical and emotional functioning 3) increasing effective coping skills for managing pain 4) reducing pain intensity. Recent evidence shows CBT provides a 1-1.5 point reduction in pain intensity on an 11-point pain scale when compared to treatment as usual.
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
- Chronic Pain, Back Pain, Back Pain Lower Back Chronic, Neck Pain
- Being tested
- Pain reprocessing therapy (PRT), Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), Usual Care
- Keywords
- Pain Reprocessing Therapy (PRT), PRT, Chronic Pain, Veterans, Neck Pain, Back Pain, Cognitive Behavioral Therapy (CBT), CBT
- Medical subject headings
- Chronic Pain, Back Pain, Neck 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 (CBT)
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Secondary outcomes (8)
Pain Interference
Last-week average pain interference 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 5 pain interference items measure the impact of pain on General Activity, Mood, Walking Ability, Normal Work, Relations with other people, Sleep, and Enjoyment of Life. Each area is rated on a numerical rating scale from 0 (does not interfere) to 10 (completely interferes).
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Satisfaction with Life
Satisfaction with Life is assessed via the self-reported 5-Item Satisfaction with Life Scale (SWLS). The SWLS measures an individual's global life satisfaction. Each item is rated on a 7-point Likert scale (1=Strongly Disagree and 7=Strongly Agree). The ratings are summed to determine an overall score.
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Depression
Depression is assessed using the self-reported 4-item Patient-Reported Outcomes Measurement Information System Depression Short Form 4a (PROMIS-Depression-SF 4a). The individual items measure negative mood, loss of interest, helplessness, and hopelessness over the past 7 days. Each item is scored 1-5, and raw scores are then converted to a T-score using pre-determined cut-offs.
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Anxiety
Anxiety is assessed using the self-reported 4-item Patient-Reported Outcomes Measurement Information System Anxiety Short Form 4a (PROMIS-Anxiety-SF 4a). The form's items measure an individual's fear, worry, tension, and difficulty concentrating over the past 7 days. Each item is scored 1-5, and raw scores are then converted to a T-score using pre-determined cut-offs.
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Fatigue
Fatigue is assessed using the self-reported 4-item Patient-Reported Outcomes Measurement Information System Fatigue Short Form 4a (PROMIS-Fatigue-SF 4a). The form's items measure an individual's fatigue intensity, fatigue frequency, fatigue-related difficulty initiating actions, and feelings of energy depletion. Each item is scored 1-5, and raw scores are then converted to a T-score using pre-determined cut-offs.
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Post-Traumatic Stress Disorder (PTSD) Symptoms
PTSD symptoms are assessed using the self-reported 6-item Primary Care PTSD Screen for DSM-5 (PC-PTSD-5). All items are Yes/No questions. The first item screens whether the respondent has experienced a traumatic event, and the other five items assess how this trauma has affected them over the past month. The score is the number of Yes answers to the last five items. Respondents who answer No to the first item receive a score of 0 and do not answer the remaining items.
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Client satisfaction
Client Satisfaction is assessed the Patients' Global Impression of Change (PGIC). The PGIC is a three-item self-report scale that measures a patient's belief about the efficacy of treatment for their physical health, emotional health, and pain severity. Each item is rated on a 7-point scale of 1 (Very much worse) to 7 (Very much improved).
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Medication Use
Medication use is assessed in two ways: 1) electronic health record review and 2) patient self-report of past-week frequency of medication, drug, or supplement use to manage pain.
Measured: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start27 Mar 2026
- Primary completionJan 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- VA Eastern Colorado Health Care System, United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Jonathan K. Ashar, PhD, Principal investigator, University of Colorado, DenverJoseph W. Frank, MD, MPH, Principal investigator, VA Eastern Colorado Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137715
- Sponsor's protocol ID
- 24-2398
- Other IDs
- HT9425-24-1-0915
- Acronym
- POWeR
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reprocessing Therapy for Veterans With Chronic Back Pain: Comparative Efficacy and Facilitators and Barriers to Implementation
- ClinicalTrials.gov ID
- NCT07137715
- Acronym / sponsor ID
- POWeR / 24-2398
- Conditions
- Chronic Pain, Back Pain, Back Pain Lower Back Chronic, Neck Pain
- Keywords
- Pain Reprocessing Therapy (PRT), PRT, Chronic Pain, Veterans, Neck Pain, Back Pain, Cognitive Behavioral Therapy (CBT), CBT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- VA Eastern Colorado Health Care System, United States Department of Defense
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Which treatment works better for lowering pain: PRT, CBT, or usual care?
- 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:
- Be randomly assigned to receive either PRT, CBT, or usual care.
- Complete questionnaires about their pain and health.
- If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.
Detailed description
The current leading psychotherapeutic treatment for chronic pain is cognitive behavioral therapy (CBT-CP), which has been found to be safe and modestly efficacious in the treatment of chronic back or neck pain (CBNP). The fundamental goal of CBT-CP is to encourage participants to adopt an active, problem-solving approach to managing the challenges associated with chronic pain. CBT-CP intervention follows a standard structure of 9 sessions with the following objectives: 1) reducing the negative impact of pain on daily life 2) improving physical and emotional functioning 3) increasing effective coping skills for managing pain 4) reducing pain intensity. Recent evidence shows CBT provides a 1-1.5 point reduction in pain intensity on an 11-point pain scale when compared to treatment as usual.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pain reprocessing therapy (PRT) | Experimental | Behavioral: 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. |
| Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) | Active comparator | Behavioral: 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain reprocessing therapy (PRT)A promising new psychotherapy for chronic pain | Behavioural | Pain reprocessing therapy (PRT) |
| Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Also: Cognitive Behavioral Therapy (CBT)A psychotherapy for chronic pain that has 30+ years of research support. | Behavioural | Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) |
| Usual CareAlso: Treatment as usualParticipants will be asked to continue to do whatever they are currently doing to manage their pain. | Other | Usual Care |
Primary outcome
Pain intensity
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
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).
8 secondary outcomes
Pain Interference
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Satisfaction with Life
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Depression
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Anxiety
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Fatigue
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Post-Traumatic Stress Disorder (PTSD) Symptoms
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Client satisfaction
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Medication Use
Time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan K. Ashar, PhD principal investigator
University of Colorado, Denver
Joseph W. Frank, MD, MPH principal investigator
VA Eastern Colorado Health Care System
1 site in 1 country: see every site and its status.
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 Chronic Pain and Back Pain, run by University of Colorado, Denver 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 31 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan K Ashar, PhD (303.724.2536, yoni.ashar.@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization). 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 31 Mar 2026.