Mindful Night-to-Day: A Pilot Feasibility Trial of a Mindfulness-Based Insomnia and Symptom Management Intervention for Patients with Hematologic Cancer.

OBJECTIVES: Patients with hematologic cancer experience severe symptoms (i.e. insomnia, fatigue, pain, distress). Few interventions addressing insomnia and other symptoms exist for this population. Mindfulness-Based Therapy for Insomnia (MBTI) may be appropriate but has only been tested in healthy outpatients. This study aimed to develop and test an adapted MBTI protocol for hematologic cancer patients. METHODS: Patient (n = 3) and clinician (n = 1) focus groups, and user-testing (N = 5) informed adaptation of Mindful Night-to-Day (MBTI+). A single-arm pilot trial (N = 32) evaluated feasibility (accrual, attrition, adherence), acceptability (intervention satisfaction), and changes to insomnia symptom severity (Insomnia Severity Index; primary outcome) and secondary outcomes (fatigue, pain, distress, pre-sleep arousal, mindfulness, symptom management self-efficacy) at baseline, post-intervention, and 1-month post-intervention. Descriptive statistics and paired sample t-tests were conducted. RESULTS: Qualitative feedback informed MBTI+ content, format, and delivery. Mindfulness was used to increase symptom awareness (sleepiness vs. fatigue). Meditations and behavioral skills were applied to inpatient treatment. MBTI+ met feasibility (N = 32/12 months; 8.1% attrition; 83.8% adherence) and acceptability (M = 3.52/4.00) benchmarks. Insomnia symptom severity decreased (d = 1.20) from baseline to post-intervention, as did most secondary outcomes. CONCLUSIONS: MBTI+ was feasible, acceptable, and showed promise for benefits throughout inpatient and outpatient treatment. Findings warrant further evaluation in a randomized trial.

Specific and shared mechanisms associated with treatment for chronic neck pain: study protocol for the SS-MECH trial.

BACKGROUND: Treatment mechanisms involve the steps or processes through which an intervention unfolds and produces change in an outcome variable. Treatment mechanisms can be specific to the intervention provided (i.e. pain modulation) or shared with other treatments (i.e. reduced fear of movement). Whether specific and shared treatment mechanisms are different across interventions and whether they lead to the outcomes seen in trials is largely unknown. The management of individuals with chronic neck pain routinely include manual therapy (MT) and resistance exercise (RE), as both approaches are included in clinical practice guidelines and both yield similar outcomes. OBJECTIVES: Our study plans to answer two research questions: 1) what are the specific mechanisms associated with MT versus interventions (and are these different), and 2) what are the shared mechanisms associated with these interventions, and do specific or shared mechanisms mediate clinical outcomes? METHODS: This study will involve a 2-group parallel (1:1) single-blinded randomized trial to compare the specific and potential shared treatment mechanisms between these two approaches. We will enroll individuals with a history of chronic neck pain and evaluate whether specific or shared mechanisms mediate clinical outcomes. RESULTS: We hypothesize that MT and RE approaches will both exhibit different specific treatment mechanisms, and that both approaches will exhibit shared treatment mechanisms, which will notably influence outcomes at both discharge and 6-months. CONCLUSIONS: This study is important because it will help identify what specific or shared treatment mechanisms are associated with different interventions and, how different treatment mechanisms influence clinical outcomes.

The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.

The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619.

Chronic Pain and Pain Management in Older Adults: Protocol and Pilot Results.

BACKGROUND: Chronic pain occurs in 30% of older adults. This prevalence rate is expected to increase, given the growth in the older adult population and the associated growth of chronic conditions contributing to pain. No population-based studies have provided detailed, longitudinal information on the experience of chronic pain in older adults; the pharmacological and nonpharmacological strategies that older adults use to manage their chronic pain; and the effect of chronic pain on patient-reported outcomes. OBJECTIVES: This article aims to describe the protocol for a population-based, longitudinal study focused on understanding the experience of chronic pain in older adults. The objectives are to determine the prevalence and characteristics of chronic pain; identify the pharmacological and nonpharmacological pain treatments used; evaluate for longitudinal differences in biopsychosocial factors; and examine how pain types and pain trajectories affect important patient-reported outcomes. Also included are the results of a pilot study. METHODS: A population-based sample of approximately 1,888 older adults will be recruited from the National Opinion Research Center at the University of Chicago's AmeriSpeak Panel to complete surveys at three waves: enrollment (Wave 1), 6 months (Wave 2), and 12 months (Wave 3). To determine the feasibility, a pilot test of the enrollment survey was conducted among 123 older adults. RESULTS: In the pilot study, older adults with chronic pain reported a range of pain conditions, with osteoarthritis being the most common. Participants reported an array of pharmacological and nonpharmacological pain strategies. Compared to participants without chronic pain, those with chronic pain reported lower physical and cognitive function and poorer quality of life. Data collection for the primary, longitudinal study is ongoing. DISCUSSION: This project will be the first longitudinal population-based study to examine the experience and overall effect of chronic pain in older adults. Pilot study results provide evidence of the feasibility of study methods. Ultimately, this work will inform the development of tailored interventions for older patients targeted to decrease pain and improve function and quality of life.

Effect of a Patient Engagement, Education, and Restructuring of Cognitions (PEERC) approach on conservative care in rotator cuff related shoulder pain treatment: a randomized control trial.

BACKGROUND: Despite similar outcomes for surgery and physical therapy (PT), the number of surgeries to treat rotator cuff related shoulder pain (RCRSP) is increasing. Interventions designed to enhance treatment expectations for PT have been shown to improve patient expectations, but no studies have explored whether such interventions influence patient reports of having had surgery, or being scheduled for surgery. The purpose of this randomized clinical trial was to examine the effect of a cognitive behavioral intervention aimed at changing expectations for PT on patient-report of having had or being scheduled for surgery and on the outcomes of PT. METHODS: The Patient Engagement, Education, and Restructuring of Cognitions (PEERC) intervention, was designed to change expectations regarding PT. PEERC was evaluated in a randomized, pragmatic "add-on" trial in by randomizing patients with RCRSP to receive either PT intervention alone (PT) or PT + PEERC. Fifty-four (54) individuals, recruited from an outpatient hospital-based orthopedic clinic, were enrolled in the trial (25 randomized to PT, 29 randomized to PT + PEERC). Outcomes assessed at enrollment, 6 weeks, discharge, and six months after discharge included the patient report of having had surgery, or being scheduled for surgery (primary) and satisfaction with PT outcome, pain, and function (secondary outcomes). RESULTS: The average age of the 54 participants was 51.81; SD = 12.54, and 63% were female. Chronicity of shoulder pain averaged 174.61 days; SD = 179.58. Study results showed that at the time of six months follow up, three (12%) of the participants in the PT alone group and one (3.4%) in the PT + PEERC group reported have had surgery or being scheduled for surgery (p = .32). There were no significant differences between groups on measures of satisfaction with the outcome of PT (p = .08), pain (p = .58) or function (p = .82). CONCLUSIONS: In patients with RCRSP, PT plus the cognitive behavioral intervention aimed at changing expectations for PT provided no additional benefit compared to PT alone with regard to patient report of having had surgery, or being scheduled to have surgery, patient reported treatment satisfaction with the outcome of PT, or improvements in pain, or function. TRIAL REGISTRATION: The trial is registered on ClinicalTrials.gov: NCT03353272 (27/11/2017).

The Mindful Reappraisal of Pain Scale (MRPS): Validation of a New Measure of Psychological Mechanisms of Mindfulness-Based Analgesia.

Objectives: Mindfulness is theorized to decrease the affective amplification of chronic pain by facilitating a shift from emotionally-laden, catastrophic pain appraisals of nociceptive input to reappraising chronic pain as an innocuous sensory signal that does not signify harm. Understanding of these hypothetical psychological mechanisms of mindfulness-based analgesia has been limited by a lack of direct measures. We conducted a series of psychometric and experimental studies to develop and validate the Mindful Reappraisal of Pain Sensations Scale (MPRS). Methods: After item generation, we conducted exploratory and confirmatory factor analyses of the MRPS in samples of opioid-treated chronic pain patients both before (n=450; n=90) and after (n=222) participating in Mindfulness-Oriented Recovery Enhancement (MORE). We then examined the convergent and divergent validity of the MRPS. Finally, in data from a randomized clinical trial (n=250), the MRPS was tested as a mediator of the effects of MORE on reducing chronic pain severity. Results: Exploratory and confirmatory factor analyses demonstrated the single-factor structure of the MRPS. The MRPS also evidenced convergent and divergent validity. Mindfulness training through MORE significantly increased MRPS scores relative to supportive psychotherapy (F4,425.03 = 16.15, p < .001). Changes in MRPS scores statistically mediated the effect of MORE on reducing chronic pain severity through 9-month follow-up. Conclusions: Taken together, these studies demonstrate that the MRPS is a psychometrically sound and valid measure of novel analgesic mechanisms of mindfulness including attentional disengagement from affective pain appraisals and interoceptive exposure to pain sensations.

Meaning-centered pain coping skills training for patients with metastatic cancer: Protocol for a randomized controlled efficacy trial.

BACKGROUND: Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with daily activities and enjoyment of life. Psychosocial interventions can improve cancer-related pain but rarely address spiritual concerns (e.g., loss of meaning, peace), which can influence the pain experience for those facing life-threatening illness. To address these needs, we systematically developed and pilot tested a novel psychosocial intervention called Meaning-Centered Pain Coping Skills Training (MCPC). In this randomized controlled trial, we aim to determine MCPC's efficacy for reducing pain interference (primary outcome) and improving secondary outcomes. We will also estimate MCPC's cost-effectiveness. METHOD/DESIGN: Patients (target N = 210) with advanced solid tumor malignancies (Stage IV) and clinically-elevated pain interference will be enrolled and block randomized with equal allocation to MCPC + enhanced usual care or enhanced usual care alone. MCPC's four, videoconferenced, 45-60 min weekly sessions will be individually delivered by trained study therapists. Primary (pain interference) and secondary (pain severity, anxiety and depressive symptoms, pain self-efficacy, social support, spiritual well-being) patient-reported outcomes will be assessed at baseline, and 8-weeks (primary endpoint) and 12-weeks after baseline. CONCLUSION: Our MCPC intervention is the first to systematically address the biopsychosocial-spiritual aspects of pain in patients with advanced cancer. If MCPC demonstrates efficacy, next steps will involve hybrid efficacy-effectiveness and implementation work to broaden access to this brief, manualized, remotely-delivered intervention, with the goal of reducing suffering in patients with life-threatening illness.

Fifty years of pain research and clinical advances: highlights and key trends.

ABSTRACT: This article highlights advances in basic science preclinical pain research, clinical research, and psychological research occurring over the 50 years since the International Association for the Study of Pain was founded. It presents important findings and key trends in these 3 areas of pain science: basic science preclinical research, clinical research, and psychological research.

Pain is associated with exclusive use and co-use of tobacco and cannabis: Findings from Wave 5 (2018-2019) of the Population Assessment of Tobacco and Health Study.

INTRODUCTION: Rates of tobacco and cannabis use are disproportionately high among individuals with pain, and evidence suggests that pain may engender greater likelihood of substance co-use, yielding additive risk. This study examined national associations of pain with past-month tobacco use, cannabis use, and co-use of tobacco and cannabis. METHODS: Data came from a nationally representative US sample of adults in Wave 5 (2018-2019) of the Population Assessment of Tobacco and Health study (N = 32,014). The sample included civilian, non-institutionalized people who use tobacco and people who do not use tobacco. Past-week pain intensity (0-10) was dichotomized (0-4 no/low pain; 5-10 moderate/severe pain). Multinomial models adjusted for demographics examined substance use category membership (no tobacco or cannabis use, exclusive cannabis use, exclusive tobacco use, co-use) as a function of pain status. RESULTS: Moderate/severe pain was associated with increased relative risk of exclusive tobacco use (RRR [CI] 2.26 [2.05, 2.49], p <.001), exclusive cannabis use (1.49 [1.22, 1.82], p <.001), and co-use of tobacco and cannabis (2.79 [2.51, 3.10], p <.001), in comparison to no tobacco or cannabis use. Additionally, moderate/severe pain was associated with increased risk of co-use compared to exclusive tobacco use (1.23 [1.11, 1.37], p <.001) and exclusive cannabis use (1.88 [1.54, 2.29], p <.001). DISCUSSION: Findings suggest that not only is pain independently associated with greater risk of exclusively using tobacco or cannabis, but pain is also associated with heightened risk of co-using both products. Future work should examine the dynamic and potentially bidirectional relationships between pain and use of cannabis and tobacco.

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial.

OBJECTIVE: For patients with advanced cancer, pain is a common and debilitating symptom that can negatively impact physical, emotional, and spiritual well-being. This trial examined the feasibility and initial effects of Meaning-Centered Pain Coping Skills Training (MCPC), a cognitive-behavioral pain management intervention with an emphasis on enhancing meaning (i.e., a personal sense of purpose, worth, and significance) and peace. METHODS: We enrolled 60 adults with stage IV solid tumor cancers and moderate-severe pain between February 2021 and February 2022. Participants were randomized 1:1 to MCPC + usual care or usual care alone. Meaning-Centered Pain Coping Skills Training consisted of four weekly 60-min individual sessions via videoconference or telephone, delivered by a trained therapist using a manualized protocol. Participants completed validated measures of pain severity, pain interference, pain self-efficacy, spiritual well-being (i.e., meaning, peace, and faith), and psychological distress at baseline and 5-week and 10-week follow-ups. RESULTS: All feasibility metrics exceeded prespecified benchmarks. Fifty-eight percent of screened patients were eligible, and 69% of eligible patients consented. Of those assigned to MCPC, 93% completed all sessions and 100% of those who completed follow-ups reported using coping skills weekly. Retention was strong at 5-week (85%) and 10-week (78%) follow-ups. Meaning-Centered Pain Coping Skills Training participants reported better scores than control participants across outcome measures, including moderate-to-large sized differences at 10-week follow-up in pain severity (Cohen's d = -0.75 [95% confidence interval: -1.36, -0.14]), pain interference (d = -0.82 [-1.45, -0.20]), and pain self-efficacy (d = 0.74 [0.13, 1.35]). CONCLUSIONS: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy testing is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04431830, registered 16 June 2020.

Cost-Effectiveness Analysis Evaluating Delivery Strategies for Pain Coping Skills Training in Women With Breast Cancer.

Pain coping skills training (PCST) is efficacious in patients with cancer, but clinical access is limited. To inform implementation, as a secondary outcome, we estimated the cost-effectiveness of 8 dosing strategies of PCST evaluated in a sequential multiple assignment randomized trial among women with breast cancer and pain (N = 327). Women were randomized to initial doses and re-randomized to subsequent doses based on their initial response (ie, ≥30% pain reduction). A decision-analytic model was designed to incorporate costs and benefits associated with 8 different PCST dosing strategies. In the primary analysis, costs were limited to resources required to deliver PCST. Quality-adjusted life-years (QALYs) were modeled based on utility weights measured with the EuroQol-5 dimension 5-level at 4 assessments over 10 months. A probabilistic sensitivity analysis was performed to account for parameter uncertainty. Implementation of PCST initiated with the 5-session protocol was more costly ($693-853) than strategies initiated with the 1-session protocol ($288-496). QALYs for strategies beginning with the 5-session protocol were greater than for strategies beginning with the 1-session protocol. With the goal of implementing PCST as part of comprehensive cancer treatment and with willingness-to-pay thresholds ranging beyond $20,000 per QALY, the strategy most likely to provide the greatest number of QALYs at an acceptable cost was a 1-session PCST protocol followed by either 5 maintenance telephone calls for responders or 5 sessions of PCST for nonresponders. A PCST program with 1 initial session and subsequent dosing based on response provides good value and improved outcomes. PERSPECTIVE: This article presents the results of a cost analysis of the delivery of PCST, a nonpharmacological intervention, to women with breast cancer and pain. Results could potentially provide important cost-related information to health care providers and systems on the use of an efficacious and accessible nonmedication strategy for pain management. TRIALS REGISTRATION: ClinicalTrials.gov: NCT02791646, registered 6/2/2016.

mHealth Coping Skills Training for Symptom Management (mCOPE) for colorectal cancer patients in early to mid-adulthood: Study protocol for a randomized controlled trial.

Background: Colorectal cancer (CRC) patients in early to mid-adulthood (≤50 years) are challenged by high symptom burden (i.e., pain, fatigue, distress) and age-related stressors (e.g., managing family, work). Cognitive behavioral theory (CBT)-based coping skills training interventions reduce symptoms and improve quality of life in cancer patients. However, traditional CBT-based interventions are not accessible to these patients (e.g., in-person sessions, during work day), nor designed to address symptoms within the context of this stage of life. We developed a mobile health (mHealth) coping skills training program for pain, fatigue and distress (mCOPE) for CRC patients in early to mid-adulthood. We utilize a randomized controlled trial to test the extent to which mCOPE reduces pain, fatigue and distress (multiple primary outcomes) and improves quality of life and symptom self-efficacy (secondary outcomes). Methods/Design: Patients (N = 160) ≤50 years with CRC endorsing pain, fatigue and/or distress are randomized 1:1 to mCOPE or standard care. mCOPE is a five-session CBT-based coping skills training program (e.g., relaxation, activity pacing, cognitive restructuring) that was adapted for CRC patients in early to mid-adulthood. mCOPE utilizes mHealth technology (e.g., videoconference, mobile app) to deliver coping skills training, capture symptom and skills use data, and provide personalized support and feedback. Self-report assessments are completed at baseline, post-treatment (5-8 weeks post-baseline; primary endpoint), and 3- and 6-months later. Conclusions: mCOPE is innovative and potentially impactful for CRC patients in early to mid-adulthood. Hypothesis confirmation would demonstrate initial efficacy of a mHealth cognitive behavioral intervention to reduce symptom burden in younger CRC patients.

Behavioral cancer pain intervention dosing: results of a Sequential Multiple Assignment Randomized Trial.

ABSTRACT: Behavioral pain management interventions are efficacious for reducing pain in patients with cancer. However, optimal dosing of behavioral pain interventions for pain reduction is unknown, and this hinders routine clinical use. A Sequential Multiple Assignment Randomized Trial (SMART) was used to evaluate whether varying doses of Pain Coping Skills Training (PCST) and response-based dose adaptation can improve pain management in women with breast cancer. Participants (N = 327) had stage I-IIIC breast cancer and a worst pain score of > 5/10. Pain severity (a priori primary outcome) was assessed before initial randomization (1:1 allocation) to PCST-Full (5 sessions) or PCST-Brief (1 session) and 5 to 8 weeks later. Responders ( > 30% pain reduction) were rerandomized to a maintenance dose or no dose and nonresponders (<30% pain reduction) to an increased or maintenance dose. Pain severity was assessed again 5 to 8 weeks later (assessment 3) and 6 months later (assessment 4). As hypothesized, PCST-Full resulted in greater mean percent pain reduction than PCST-Brief (M [SD] = -28.5% [39.6%] vs M [SD]= -14.8% [71.8%]; P = 0.041). At assessment 3 after second dosing, all intervention sequences evidenced pain reduction from assessment 1 with no differences between sequences. At assessment 4, all sequences evidenced pain reduction from assessment 1 with differences between sequences ( P = 0.027). Participants initially receiving PCST-Full had greater pain reduction at assessment 4 ( P = 0.056). Varying PCST doses led to pain reduction over time. Intervention sequences demonstrating the most durable decreases in pain reduction included PCST-Full. Pain Coping Skills Training with intervention adjustment based on response can produce sustainable pain reduction.

A Novel Movement-Evoked Pain Provocation Test for Older Adults With Persistent Low Back Pain: Safety, Feasibility, and Associations With Self-reported Physical Function and Usual Gait Speed.

OBJECTIVES: Low back pain (LBP) is highly prevalent and disabling for older adults. Movement-evoked pain is an emerging measure that may help to predict disability; but is not currently a part of geriatric LBP clinical care. This study tested the safety and feasibility of a new Movement-Evoked Provocation Test for Low Back Pain in Older Adults (MEPLO). We also compared associations between movement-evoked pain via 2 different scoring methods and disability-associated outcomes. MATERIALS AND METHODS: Thirty-nine older adults with persistent LBP provided baseline recalled and resting pain ratings, self-reported physical function, and usual gait speed. Participants then completed MEPLO, involving 4 tasks essential for functional independence: chair rises, trunk rotation, reaching, and walking. Movement-evoked pain was then quantified using the traditional change score (delta) method of pain premovement to postmovement; and also, a new aggregate method that combines pain ratings after the 4 tasks. RESULTS: No safety or feasibility issues were identified. Compared with the delta score, the aggregate score was more strongly associated with self-reported physical function (beta: -0.495 vs. -0.090) and usual gait speed (beta: -0.450 vs. -0.053). Similarly, the aggregate score was more strongly associated with self-reported physical function than recalled and resting pain (beta: -0.470, -0.283, and 0.136, respectively). DISCUSSION: This study shows the safety and feasibility of testing movement-evoked pain in older adults with persistent LBP, and its potential superiority to traditional pain measures. Future studies must validate these findings and test the extent to which MEPLO is implementable to change with geriatric LBP standard of care.

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.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.