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

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:

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

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
• 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