Pain Reprocessing Therapy for Chronic Back Pain

Overseen By Jonathan K. Ashar, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Substance abuse, Psychosis, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 5-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests which treatment works best for people with chronic back pain. It compares Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), and usual care (current pain management practices). The goal is to determine which method most effectively reduces pain and addresses related issues. Individuals experiencing more back pain than leg pain for at least half the days over the last 6 months may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could significantly enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems like you can continue with your usual care, which may include your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is safe and effective. Studies have found that it reduces pain levels and improves daily functioning. It has been applied to various types of pain, such as back pain and arthritis, and patients generally tolerate it well without major side effects.

Pain Reprocessing Therapy (PRT) also shows promise for treating chronic pain. One study found that 98% of patients experienced improvement, and 66% were pain-free or nearly pain-free by the end of the treatment. These findings suggest that PRT is both effective and well-received by patients, with no major negative effects reported.

Both treatments appear to be safe options based on current research, aiming to manage chronic pain without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Pain Reprocessing Therapy (PRT) for chronic back pain because it takes a unique approach by targeting the brain's perception of pain. Unlike traditional treatments that often focus on physical aspects or medication, PRT educates patients about the brain's role in pain and helps them reframe pain sensations as non-threatening through mindfulness and positive reinforcement. This method aims to break the pain-fear cycle and reduce the perception of pain, offering a potentially transformative approach to managing chronic back pain. Additionally, the therapy is delivered remotely, increasing accessibility for patients.

What evidence suggests that this trial's treatments could be effective for chronic back pain?

Research has shown that Pain Reprocessing Therapy (PRT), a treatment in this trial, can be very effective for chronic back pain. In one study, 98% of patients felt better, and 66% became pain-free or almost pain-free. Another study found that patients experienced significantly less pain after PRT compared to usual care or a placebo. Cognitive Behavioral Therapy (CBT), another treatment option in this trial, has also proven effective for chronic pain. Studies indicate that CBT can improve pain, enhance function, and reduce fear of pain. Both therapies offer promising results for people with chronic pain. ^{1 4 5 6 7}

Who Is on the Research Team?

Jonathan K. Ashar, Ph.D.

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults with chronic back pain lasting at least 6 months, where the back pain is more frequent and severe than leg pain. Participants must have a consistent level of pain and be able to attend telehealth appointments. Those with recent major medical events, surgeries, or psychiatric issues, or who are involved in litigation related to their pain cannot join.

Inclusion Criteria

My back pain has been at least 4 out of 10 in the last week.

I have had back pain for most days in the past 6 months.

My back pain is more severe than my leg pain.

Exclusion Criteria

You were hospitalized for mental health reasons in the past 5 years.

I have lost 20lbs or more recently without trying.

Major, interfering changes in employment or housing anticipated over the next six months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), or continue with usual care for chronic pain management

5-12 weeks

9 sessions (remote) for CBT, 8 sessions (remote) for PRT

Follow-up

Participants are monitored for safety and effectiveness after treatment

1.5 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
• Pain Reprocessing Therapy (PRT)
• Usual care

Trial Overview The study compares Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT) for Chronic Pain, and usual care to determine which method best reduces chronic back pain and improves associated problems. It aims to find out if PRT can effectively lower chronic pain compared to CBT or ongoing treatments.

How Is the Trial Designed?

Group I: Pain reprocessing therapy (PRT) Experimental Treatment 1 Intervention

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 flexible, ranging from 5-12 weeks, to increase accessibility. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.

Group II: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Active Control 1 Intervention

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 5 - 12 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.

Group III: Usual Care Active Control 1 Intervention

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 5 weeks, the expected mean completion time of the PRT and CBT arms, and may be adjusted at mid-enrollment to match treatment arm length more closely.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) is effective in addressing various factors that influence chronic low back pain (CLBP), but the term itself is too broad for future research, necessitating specific definitions based on the problems being addressed.

Despite its proven effectiveness, CBT is not widely implemented in clinical practice for CLBP, highlighting the need for early adoption and a public health approach to operationalize these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. Hanscom, DA., Brox, JI., Bunnage, R.[2020]

The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.

This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) shows promising effectiveness in primary care settings, with significant improvements in pain intensity and functional limitations observed by the third appointment among 118 patients.

The most effective components of Brief CBT-CP included psychoeducation, goal setting, pacing, and relaxation training, suggesting that these strategies are beneficial for managing chronic pain without relying on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. Beehler, GP., Murphy, JL., King, PR., et al.[2020]

In a randomized controlled trial, two-thirds of participants receiving pain reprocessing therapy (PRT) reported significant relief from chronic back pain, suggesting its efficacy as a novel psychological treatment.

Qualitative interviews with 32 adults revealed that participants attributed their pain relief to mechanisms such as reappraising pain to reduce fear, understanding the emotional connections to pain, and building strong social connections with therapists and peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I don't have chronic back pain anymore": Patient Experiences in Pain Reprocessing Therapy for Chronic Back Pain. Tankha, H., Lumley, MA., Gordon, A., et al.[2023]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12153248/

Effects of cognitive behavioral therapy combined with physical ... The combination of CBT intervention and a basic physical therapy program results in better pain reduction in patients with CLBP than in those ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... Results of the study suggest that both treatments have potential utility in treating adults with refractory CLBP and improving pain, function, and quality-of- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35345623/

Evaluation of Cognitive Behavioral Therapy on Improving ... Conclusion: CBT is beneficial in patients with CLBP for improving pain, disability, fear avoidance, and self-efficacy in CLBP patients. Further ...

4. va.gov va.gov/painmanagement/docs/cbt-cp_therapist_manual.pdf

Cognitive Behavioral Therapy for Chronic Pain Program evaluation results indicate that the training in and implementation of these therapies have significantly enhanced therapist skills and Veteran outcomes ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666521224000310

Cognitive behavioral therapy for chronic pain supported by ... On the other hand, this study found that AI-CBT-CP achieved equivalent outcomes compared to a typical 10-session course of therapist-delivered treatment, while ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10009772/

Cognitive Behavioral Therapy for Chronic Pain in Veterans We expected that CBT-CP treatment provided by newly trained clinicians would be associated with statistically significant decreases in pain ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10250557/

Using Daily Ratings to Examine Treatment Dose and ... Across multiple trials, CBT-CP has been shown to reduce pain intensity and improve functioning for individuals with back pain [2], osteoarthritis [3], and ...