Cognitive Therapy, Mindfulness-Based Stress Reduction, and Behavior Therapy for the Treatment of Chronic Pain: Predictors and Moderators of Treatment Response.

Psychosocial interventions for people with chronic pain produce significant improvements in outcomes, but these effects on average are modest with much variability in the benefits conferred on individuals. To enhance the magnitude of treatment effects, characteristics of people that might predict the degree to which they respond more or less well could be identified. People with chronic low back pain (N = 521) participated in a randomized controlled trial which compared cognitive therapy, mindfulness-based stress reduction, behavior therapy and treatment as usual. Hypotheses regarding predictors and/or moderators were based on the Limit, Activate, and Enhance model; developed to predict and explain moderators/predictors of psychosocial pain treatments. Results were: 1) low levels of cognitive/behavioral function at pre-treatment predicted favorable pre- to post-treatment outcomes; 2) favorable expectations of benefit from treatment and sound working alliances predicted favorable pre- to post-treatment outcomes; 3) women benefited more than men. These effects emerged without regard to treatment condition. Of note, high levels of cognitive/behavioral function at pre-treatment predicted favorable outcomes only for people in the treatment as usual condition. Analyses identified a set of psychosocial variables that may act as treatment predictors across cognitive therapy, mindfulness-based stress reduction and behavior therapy, as hypothesized by the Limit, Activate, and Enhance model if these 3 treatments operate via similar mechanisms. Findings point toward people who may and who may not benefit fully from the 3 psychosocial treatments studied here, and so may guide future research on matching people to these kinds of psychosocial approaches or to other (eg, forced-based interventions) non-psychosocial approaches. TRIAL REGISTRATION: The ClinicalTrials.gov Identifier is NCT02133976. PERSPECTIVE: This article examines potential predictors/moderators of response to psychosocial treatments for chronic pain. Results could guide efforts to match people to the most effective treatment type or kind.

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 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.

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.

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.

Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for people with chronic low back pain: A comparative mechanisms study.

OBJECTIVE: Cognitive therapy (CT), mindfulness-based stress reduction (MBSR), and behavior therapy (BT) for chronic pain treatment produce outcome improvements. Evidence also suggests that changes in putative therapeutic mechanisms are associated with changes in outcomes. Nonetheless, methodological limitations preclude clear understanding of how psychosocial chronic pain treatments work. In this comparative mechanism study, we examined evidence for specific and shared mechanism effects across the three treatments. METHOD: CT, MBSR, BT, and treatment as usual (TAU) were compared in people with chronic low back pain (N = 521). Eight individual sessions were administered with weekly assessments of "specific" mechanisms (pain catastrophizing, mindfulness, behavior activation) and outcomes. RESULTS: CT, MBSR, and BT produced similar pre- to posttreatment effects on all mechanism variables, and all three active treatments produced greater improvements than TAU. Participant ratings of expectations of benefit and working alliance were similar across treatments. Lagged and cross-lagged analyses revealed that prior week changes in both mechanism and outcome factors predicted next week changes in their counterparts. Analyses of variance contributions suggested that changes in pain catastrophizing and pain self-efficacy were consistent unique predictors of subsequent outcome changes. CONCLUSIONS: Findings support the operation of shared mechanisms over specific ones. Given significant lagged and cross-lagged effects, unidirectional conceptualizations-mechanism to outcome-need to be expanded to include reciprocal effects. Thus, prior week changes in pain-related cognitions could predict next week changes in pain interference which in turn could predict next week changes in pain-related cognitions, in what may be an upward spiral of improvement. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial.

ABSTRACT: Trials of cognitive therapy (CT), mindfulness-based stress reduction (MBSR), and behavior therapy (BT) suggest that all 3 treatments produce reductions in pain and improvements in physical function, mood, and sleep disturbance in people with chronic pain conditions. Fewer studies have compared the relative efficacies of these treatments. In this randomized controlled study, we compared CT, MBSR, BT, and treatment as usual (TAU) in a sample of people with chronic low back pain (N = 521). Eight individual sessions were administered with weekly assessments of outcomes. Consistent with the prior work, we found that CT, MBSR, and BT produced similar pretreatment to posttreatment effects on all outcomes and revealed similar levels of maintenance of treatment gains at 6-month follow-up. All 3 active treatments produced greater improvements than TAU. Weekly assessments allowed us to assess rates of change; ie, how quickly a given treatment produced significant differences, compared with TAU, on a given outcome. The 3 treatments differed significantly from TAU on average by session 6, and this rate of treatment effect was consistent across all treatments. Results suggest the possibility that the specific techniques included in CT, MBSR, and BT may be less important for producing benefits than people participating in any techniques rooted in these evidence-based psychosocial treatments for chronic pain.

A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial.

BACKGROUND: Chronic pain is common, disabling, and costly. Few clinical trials have examined cognitive behavioral therapy (CBT) interventions embedded in primary care settings to improve chronic pain among those receiving long-term opioid therapy. OBJECTIVE: To determine the effectiveness of a group-based CBT intervention for chronic pain. DESIGN: Pragmatic, cluster randomized controlled trial. (ClinicalTrials.gov: NCT02113592). SETTING: Kaiser Permanente health care systems in Georgia, Hawaii, and the Northwest. PARTICIPANTS: Adults (aged ≥18 years) with mixed chronic pain conditions receiving long-term opioid therapy. INTERVENTION: A CBT intervention teaching pain self-management skills in 12 weekly, 90-minute groups delivered by an interdisciplinary team (behaviorist, nurse, physical therapist, and pharmacist) versus usual care. MEASUREMENTS: Self-reported pain impact (primary outcome, as measured by the PEGS scale [pain intensity and interference with enjoyment of life, general activity, and sleep]) was assessed quarterly over 12 months. Pain-related disability, satisfaction with care, and opioid and benzodiazepine use based on electronic health care data were secondary outcomes. RESULTS: A total of 850 patients participated, representing 106 clusters of primary care providers (mean age, 60.3 years; 67.4% women); 816 (96.0%) completed follow-up assessments. Intervention patients sustained larger reductions on all self-reported outcomes from baseline to 12-month follow-up; the change in PEGS score was -0.434 point (95% CI, -0.690 to -0.178 point) for pain impact, and the change in pain-related disability was -0.060 point (CI, -0.084 to -0.035 point). At 6 months, intervention patients reported higher satisfaction with primary care (difference, 0.230 point [CI, 0.053 to 0.406 point]) and pain services (difference, 0.336 point [CI, 0.129 to 0.543 point]). Benzodiazepine use decreased more in the intervention group (absolute risk difference, -0.055 [CI, -0.099 to -0.011]), but opioid use did not differ significantly between groups. LIMITATION: The inclusion of only patients with insurance in large integrated health care systems limited generalizability, and the clinical effect of change in scores is unclear. CONCLUSION: Primary care-based CBT, using frontline clinicians, produced modest but sustained reductions in measures of pain and pain-related disability compared with usual care but did not reduce use of opioid medication. PRIMARY FUNDING SOURCE: National Institutes of Health.

Couple Communication in Cancer: Protocol for a Multi-Method Examination.

Cancer and its treatment pose challenges that affect not only patients but also their significant others, including intimate partners. Accumulating evidence suggests that couples' ability to communicate effectively plays a major role in the psychological adjustment of both individuals and the quality of their relationship. Two key conceptual models have been proposed to account for how couple communication impacts psychological and relationship adjustment: the social-cognitive processing (SCP) model and the relationship intimacy (RI) model. These models posit different mechanisms and outcomes, and thus have different implications for intervention. The purpose of this project is to test and compare the utility of these models using comprehensive and methodologically rigorous methods. Aims are: (1) to examine the overall fit of the SCP and RI models in explaining patient and partner psychological and relationship adjustment as they occur on a day-to-day basis and over the course of 1 year; (2) to examine the fit of the models for different subgroups (males vs. females, and patients vs. partners); and (3) to examine the utility of various methods of assessing communication by examining the degree to which baseline indices from different measurement strategies predict self-reported adjustment at 1-year follow up. The study employs a longitudinal, multi-method approach to examining communication processes including: standard self-report questionnaires assessing process and outcome variables collected quarterly over the course of 1 year; smartphone-based ecological momentary assessments to sample participant reports in real time; and laboratory-based couple conversations from which we derive observational measures of communicative behavior and affective expression, as well as vocal indices of emotional arousal. Participants are patients with stage II-IV breast, colon, rectal, or lung cancer and their spouses/partners, recruited from two NCI-designated comprehensive cancer centers. Results will be published in scientific journals, presented at scientific conferences, and conveyed to a larger audience through infographics and social media outlets. Findings will inform theory, measurement, and the design and implementation of efficacious interventions aimed at optimizing both patient and partner well-being.

Yoga Practice Predicts Improvements in Day-to-Day Pain in Women With Metastatic Breast Cancer.

CONTEXT: Women with metastatic breast cancer (MBC) experience a significant symptom burden, including cancer pain. Yoga is a mind-body discipline that has shown promise for alleviating cancer pain, but few studies have included patients with metastatic disease or examined the acute effects of yoga practice. OBJECTIVES: To determine whether daily pain changed significantly during a randomized controlled trial of the Mindful Yoga program among women with MBC and whether time spent in yoga practice was related to daily pain. METHODS: On alternate weeks during the intervention period, we collected daily measures of pain from a subset of 48 women randomized to either yoga (n = 30) or a support group condition (n = 18). We also assessed daily duration of yoga practice among patients randomized to yoga. RESULTS: Pain levels were low for women in both conditions, and no differential treatment effects were found on daily pain. However, among women randomized to yoga, a dose/response relationship was found between yoga practice duration and daily pain. When patients had spent relatively more time practicing yoga across two consecutive days, they were more likely to experience lower pain on the next day. This finding is consistent with an earlier MBC study. Meditation practice showed the strongest association with lower daily pain. CONCLUSION: Findings suggest that yoga practice (meditation practice in particular) is associated with acute improvements in cancer pain, and that yoga interventions may be more impactful if tested in a sample of patients with advanced cancer in which pain is relatively elevated.

Enhancing meaning in the face of advanced cancer and pain: Qualitative evaluation of a meaning-centered psychosocial pain management intervention.

OBJECTIVES: The objectives of this study were to obtain patient evaluations of the content, structure, and delivery modality of Meaning-Centered Pain Coping Skills Training (MCPC), a novel psychosocial intervention for patients with advanced cancer and pain. MCPC aims to help patients connect with valued sources of meaning in their lives (e.g., family relationships), while providing training in evidence-based cognitive and behavioral skills (e.g., guided imagery) to reduce pain. METHODS: Semi-structured interviews were conducted with 12 patients with stage IV solid tumor cancers and persistent pain. Transcripts were analyzed using methods from applied thematic analysis. RESULTS: When evaluating MCPC's educational information and skills training descriptions, participants described ways in which this content resonated with their experience. Many coped with their pain and poor prognosis by relying on frameworks that provided them with a sense of meaning, often involving their personally held religious or spiritual beliefs. They also expressed a need for learning ways to cope with pain in addition to taking medication. A few participants offered helpful suggestions for refining MCPC's content, such as addressing common co-occurring symptoms of sleep disturbance and fatigue. Concerning MCPC's structure and delivery modality, most participants preferred that sessions include their family caregiver and described remote delivery (i.e., telephone or videoconference) as being more feasible than attending in-person sessions. SIGNIFICANCE OF RESULTS: Participants were interested in an intervention that concurrently focuses on learning pain coping skills and enhancing a sense of meaning. Using remote delivery modalities may reduce access barriers (e.g., travel) that would otherwise prevent many patients from utilizing psychosocial services.

Mind-Body Therapies for Opioid-Treated Pain: A Systematic Review and Meta-analysis.

Importance: Mind-body therapies (MBTs) are emerging as potential tools for addressing the opioid crisis. Knowing whether mind-body therapies may benefit patients treated with opioids for acute, procedural, and chronic pain conditions may be useful for prescribers, payers, policy makers, and patients. Objective: To evaluate the association of MBTs with pain and opioid dose reduction in a diverse adult population with clinical pain. Data Sources: For this systematic review and meta-analysis, the MEDLINE, Embase, Emcare, CINAHL, PsycINFO, and Cochrane Library databases were searched for English-language randomized clinical trials and systematic reviews from date of inception to March 2018. Search logic included (pain OR analgesia OR opioids) AND mind-body therapies. The gray literature, ClinicalTrials.gov, and relevant bibliographies were also searched. Study Selection: Randomized clinical trials that evaluated the use of MBTs for symptom management in adults also prescribed opioids for clinical pain. Data Extraction and Synthesis: Independent reviewers screened citations, extracted data, and assessed risk of bias. Meta-analyses were conducted using standardized mean differences in pain and opioid dose to obtain aggregate estimates of effect size with 95% CIs. Main Outcomes and Measures: The primary outcome was pain intensity. The secondary outcomes were opioid dose, opioid misuse, opioid craving, disability, or function. Results: Of 4212 citations reviewed, 60 reports with 6404 participants were included in the meta-analysis. Overall, MBTs were associated with pain reduction (Cohen d = -0.51; 95% CI, -0.76 to -0.26) and reduced opioid dose (Cohen d = -0.26; 95% CI, -0.44 to -0.08). Studies tested meditation (n = 5), hypnosis (n = 25), relaxation (n = 14), guided imagery (n = 7), therapeutic suggestion (n = 6), and cognitive behavioral therapy (n = 7) interventions. Moderate to large effect size improvements in pain outcomes were found for meditation (Cohen d = -0.70), hypnosis (Cohen d = -0.54), suggestion (Cohen d = -0.68), and cognitive behavioral therapy (Cohen d = -0.43) but not for other MBTs. Although most meditation (n = 4 [80%]), cognitive-behavioral therapy (n = 4 [57%]), and hypnosis (n = 12 [63%]) studies found improved opioid-related outcomes, fewer studies of suggestion, guided imagery, and relaxation reported such improvements. Most MBT studies used active or placebo controls and were judged to be at low risk of bias. Conclusions and Relevance: The findings suggest that MBTs are associated with moderate improvements in pain and small reductions in opioid dose and may be associated with therapeutic benefits for opioid-related problems, such as opioid craving and misuse. Future studies should carefully quantify opioid dosing variables to determine the association of mind-body therapies with opioid-related outcomes.

Greater mindfulness associated with lower pain, fatigue, and psychological distress in women with metastatic breast cancer.

OBJECTIVE: Women with metastatic breast cancer (MBC) report high levels of disease-related symptoms including pain, fatigue, psychological distress, and sleep disturbance. Mindfulness may be particularly relevant to women with MBC given the high symptom burden and psychological toll of this disease; however, the topic is understudied among this patient population. Therefore, we aimed to test the associations between mindfulness and patient-reported symptoms among a sample of women with MBC. METHODS: Sixty-four women with MBC completed baseline questionnaires of mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF]) and symptoms of pain severity and interference, fatigue, psychological distress, and sleep disturbance as part of a randomized controlled trial of a Mindful Yoga intervention. Correlational analyses of data collected at baseline tested associations between the five mindfulness facets (observing, describing, acting with awareness, nonjudging, and nonreactivity) and patient-reported measures of symptoms. RESULTS: Overall, higher mindfulness was associated with lower symptom levels including lower pain severity, pain interference, fatigue, anxiety, depression, and sleep disturbance. However, degree of association varied by mindfulness facet. Nonreactivity, nonjudging, and describing showed the most frequent associations and largest effect sizes across symptoms, while observing showed the least frequent associations and lowest effect sizes. CONCLUSIONS: Mindfulness-and in particular nonreactivity, nonjudging, and describing-may be a personal resource for women with MBC in coping with complex symptoms of this life-threatening illness. Findings are discussed relative to their implications for interventions aimed at increasing mindfulness in this vulnerable population.

Acceptability and Feasibility of a Mindfulness-Based Intervention for Pain Catastrophizing among Persons with Sickle Cell Disease.

BACKGROUND: Few investigators have developed and tested nonpharmacological interventions for helping persons with sickle cell disease (SCD) manage persistent pain. AIMS: The purpose of this pilot study was to examine the feasibility and acceptability of a mindfulness-based intervention (MBI) in adults with SCD and chronic pain and to gather preliminary data on its efficacy. DESIGN: Data on feasibility and acceptability, including recruitment, retention, and attendance rates, were collected during a single-site, randomized control trial. Participants were randomly assigned to either a 6-session group telephonic MBI or a wait-listed control. Pain catastrophizing was assessed at baseline and at weeks 1, 3, and 6. SETTING: Outpatient, comprehensive, interdisciplinary sickle cell disease center in the Southeast. PARTICIPANTS/SUBJECTS: Adults at least 18 years of age with a self-reported diagnosis of sickle cell disease who self-identified as having chronic, non-cancer pain that persisted on most days for at least 6 months and adversely affected function and/or well-being. METHODS: Seventy-eight adults were recruited; 18 (23%) declined to participate; 60 were randomly assigned to either the MBI (N = 40) or control (N = 20). Of those, 14 (35%) from the MBI and 12 (60%) from the control group withdrew immediately after random allocation, resulting in 34 evaluable cases (MBI: N = 26; control: N = 8). RESULTS: Among the 26 assigned to MBI, the median number of sessions attended per person was 4; 7 (27%) attended all six sessions. Qualitative findings indicated that MBI participants viewed the program as acceptable and liked the telephonic format, community, and content. Reductions in pain catastrophizing outcomes were identified after intervention. CONCLUSIONS: An MBI is feasible and acceptable for persons with SCD experiencing chronic pain. A larger randomized controlled trial to establish MBI efficacy on pain and related outcomes for SCD will provide nonpharmacologic, behavioral pain management options for nurses and other clinicians caring for persons with SCD and chronic pain.

Feasibility of a mindful yoga program for women with metastatic breast cancer: results of a randomized pilot study.

PURPOSE: Patients with metastatic breast cancer (MBC) experience high levels of symptoms. Yoga interventions have shown promise for improving cancer symptoms but have rarely been tested in patients with advanced disease. This study examined the acceptability of a comprehensive yoga program for MBC and the feasibility of conducting a randomized trial testing the intervention. METHODS: Sixty-three women with MBC were randomized with a 2:1 allocation to yoga or a support group comparison condition. Both interventions involved eight weekly group sessions. Feasibility was quantified using rates of accrual, attrition, and session attendance. Acceptability was assessed with a standardized self-report measure. Pain, fatigue, sleep quality, psychological distress, mindfulness, and functional capacity were assessed at baseline, post-intervention, and 3 and 6 months post-intervention. RESULTS: We met goals for accrual and retention, with 50% of eligible patients enrolled and 87% of randomized participants completing post-intervention surveys. Sixty-five percent of women in the yoga condition and 90% in the support group attended ≥ 4 sessions. Eighty percent of participants in the yoga condition and 65% in the support group indicated that they were highly satisfied with the intervention. Following treatment, women in the yoga intervention had modest improvements in some outcomes; however, overall symptom levels were low for women in both conditions. CONCLUSIONS: Findings suggest that the yoga intervention content was highly acceptable to patients with MBC, but that there are challenges to implementing an intervention involving eight group-based in-person sessions. Alternative modes of delivery may be necessary to reach patients most in need of intervention.

Preliminary efficacy of a lovingkindness meditation intervention for patients undergoing biopsy and breast cancer surgery: A randomized controlled pilot study.

PURPOSE: Despite more women undergoing treatment for breast cancer and increased survival rates, many women suffer from anxiety and physical symptoms (e.g., pain, fatigue) surrounding diagnosis and surgery. Research investigating the efficacy of psychosocial interventions for breast cancer patients during this period is limited. This randomized controlled pilot study examined the effect of a brief lovingkindness meditation intervention on these key outcomes. METHODS: Participants were 60 women who underwent core needle breast biopsy, received an abnormal biopsy result, and underwent breast surgery (White = 73.6%; African American = 22.6%; Asian American = 3.8%; Age M = 56). Participants were randomly assigned to one of three treatment conditions at breast biopsy: (1) lovingkindness meditation, (2) music, and (3) usual care. Assessments of anxiety, pain, fatigue, physiologic reactivity, and self-compassion occurred prior to patients' biopsy, following biopsy, 1 week after receipt of biopsy results, and 1 week following breast surgery. RESULTS: Multilevel modeling analyses demonstrated that lovingkindness meditation significantly improved pain (p = 0.02), self-compassion (p = 0.004), and heart rate (p = 0.02) over time compared to control conditions. There was a trend for anxiety (p = 0.05). Music significantly improved pain (p = 0.04) compared to usual care. CONCLUSIONS: These findings provide preliminary evidence for the feasibility and efficacy of a lovingkindness meditation intervention for breast cancer patients during the diagnostic and surgical period. Improving psychological and physical well-being during this time frame has the potential to improve longer-term health outcomes during adjuvant treatment and survivorship. Interventions that cultivate positive adjustment during the diagnostic and surgical period of breast cancer are an important area of future research.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

BACKGROUND: Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. METHODS/DESIGN: This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. DISCUSSION: This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592.

The Role of Cognitive Content and Cognitive Processes in Chronic Pain: An Important Distinction?

OBJECTIVES: Pain-related cognitive content (what people think about pain) and cognitive processes (how people think about pain; what they do with their pain-related thoughts) and their interaction are hypothesized to play distinct roles in patient function. However, questions have been raised regarding whether it is possible or practical to assess cognitive content and cognitive process as distinct domains. The aim of this study was to determine the extent to which measures that seem to assess mostly pain-related cognitive content, cognitive processes, and content and process, are relatively independent from each other and contribute unique variance to the prediction of patient function. MATERIALS AND METHODS: Individuals with chronic low back pain (N=165) participating in an ongoing RCT were administered measures of cognitions, pain, and function (depressive symptoms and pain interference) pretreatment. RESULTS: Analyses provided support for the hypothesis that cognitive content and cognitive process, while related, can be assessed as distinct components. However, the measure assessing a cognitive process-mindfulness-evidenced relatively weak associations with function, especially compared with the stronger and more consistent findings for the measures of content (catastrophizing and self-efficacy). DISCUSSION: The results provide preliminary evidence for the possibility that mindfulness could have both benefits and costs. Research to evaluate this possibility is warranted.

Imaging-Guided Core-Needle Breast Biopsy: Impact of Meditation and Music Interventions on Patient Anxiety, Pain, and Fatigue.

PURPOSE: To evaluate the impact of guided meditation and music interventions on patient anxiety, pain, and fatigue during imaging-guided breast biopsy. METHODS: After giving informed consent, 121 women needing percutaneous imaging-guided breast biopsy were randomized into three groups: (1) guided meditation; (2) music; (3) standard-care control group. During biopsy, the meditation and music groups listened to an audio-recorded, guided, loving-kindness meditation and relaxing music, respectively; the standard-care control group received supportive dialogue from the biopsy team. Immediately before and after biopsy, participants completed questionnaires measuring anxiety (State-Trait Anxiety Inventory Scale), biopsy pain (Brief Pain Inventory), and fatigue (modified Functional Assessment of Chronic Illness Therapy-Fatigue). After biopsy, participants completed questionnaires assessing radiologist-patient communication (modified Questionnaire on the Quality of Physician-Patient Interaction), demographics, and medical history. RESULTS: The meditation and music groups reported significantly greater anxiety reduction (P values < .05) and reduced fatigue after biopsy than the standard-care control group; the standard-care control group reported increased fatigue after biopsy. The meditation group additionally showed significantly lower pain during biopsy, compared with the music group (P = .03). No significant difference in patient-perceived quality of radiologist-patient communication was noted among groups. CONCLUSIONS: Listening to guided meditation significantly lowered biopsy pain during imaging-guided breast biopsy; meditation and music reduced patient anxiety and fatigue without compromising radiologist-patient communication. These simple, inexpensive interventions could improve women's experiences during core-needle breast biopsy.