Pain Reprocessing Therapy for Veterans With Chronic Back Pain: Comparative Efficacy and Facilitators and Barriers to Implementation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessment will be completed via automated transmission of a REDCap link, and as such is inherently blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Usual Care (Other)
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.
干预措施: Pain reprocessing therapy (PRT) (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.
干预措施: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) (Behavioral)
结局指标
主要结局
Pain intensity
时间窗: 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).
次要结局
- Pain Interference(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Satisfaction with Life(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Depression(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Anxiety(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Fatigue(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Post-Traumatic Stress Disorder (PTSD) Symptoms(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Client satisfaction(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Medication Use(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Pain Interference(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Satisfaction with Life(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Depression(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Anxiety(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Fatigue(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Post-Traumatic Stress Disorder (PTSD) Symptoms(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Client satisfaction(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)
- Medication Use(Post-treatment (at an average of 10 weeks) and 26, 39, and 52 weeks post-randomization)