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

150 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Pain Reprocessing Therapy for Chronic Back Pain?

Research shows that Pain Reprocessing Therapy (PRT) led to the elimination or near-elimination of chronic back pain in two-thirds of patients, focusing on changing how patients perceive and react to pain. Additionally, Cognitive Behavioral Therapy (CBT) is recognized as effective for chronic pain, suggesting that similar psychological approaches can be beneficial. ^{1 2 3 4 5}

Is Pain Reprocessing Therapy (PRT) safe for humans?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), which is similar to Pain Reprocessing Therapy, is considered a safe alternative to opioid pain medications. ^{1 3 4 6 7}

How is Pain Reprocessing Therapy (PRT) different from other treatments for chronic back pain?

Pain Reprocessing Therapy (PRT) is unique because it focuses on changing how patients perceive and react to pain by reducing fear and reinterpreting pain as a neutral sensation, rather than just managing symptoms. It also emphasizes the connection between pain, emotions, and stress, and the importance of social support, which is different from traditional treatments that may not address these psychological and social aspects. ^{1 2 4 8 9}

What is the purpose of this trial?

This trial compares three treatments for chronic pain: a new therapy (PRT), a well-known therapy (CBT), and usual care. It focuses on adults with chronic pain, especially those from diverse and lower-income backgrounds. PRT aims to change how patients perceive their pain, making it seem less threatening and more manageable.

Research Team

Jonathan K. Ashar, Ph.D.

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

"I don't have chronic back pain anymore": Patient Experiences in Pain Reprocessing Therapy for Chronic Back Pain. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Assessing the role of cognitive behavioral therapy in the management of chronic nonspecific back pain. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Examining what factors mediate treatment effect in chronic low back pain: A mediation analysis of a Cognitive Functional Therapy clinical trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive Functional Therapy for Disabling Nonspecific Chronic Low Back Pain: Multiple Case-Cohort Study. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: Protocol for a Randomized Study Funded by the US Department of Veterans Affairs Health Services Research and Development Program. [2023]