The effects of telehealth-delivered mindfulness meditation, cognitive therapy, and behavioral activation for chronic low back pain: a randomized clinical trial.

BACKGROUND: Chronic low back pain (CLBP) is a significant problem affecting millions of people worldwide. Three widely implemented psychological techniques used for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). This study aimed to evaluate the relative immediate (pre- to post-treatment) and longer term (pre-treatment to 3- and 6-month follow-ups) effects of group, videoconference-delivered CT, BA, and MM for CLBP. METHODS: This is a secondary analysis of a three-arm, randomized clinical trial comparing the effects of three active treatments-CT, BA, and MM-with no inert control condition. Participants were N = 302 adults with CLBP, who were randomized to condition. The primary outcome was pain interference, and other secondary outcomes were also examined. The primary study end-point was post-treatment. Intent-to-treat analyses were undertaken for each time point, with the means of the changes in outcomes compared among the three groups using an analysis of variance (ANOVA). Effect sizes and confidence intervals are also reported. RESULTS: Medium-to-large effect size reductions in pain interference were found within BA, CT, and MM (ds from - .71 to - 1.00), with gains maintained at both follow-up time points. Effect sizes were generally small to medium for secondary outcomes for all three conditions (ds from - .20 to - .71). No significant between-group differences in means or changes in outcomes were found at any time point, except for change in sleep disturbance from pre- to post-treatment, improving more in BA than MM (d = - .49). CONCLUSIONS: The findings from this trial, one of the largest telehealth trials of psychological treatments to date, critically determined that group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access. The pattern of results demonstrated similar improvements across treatments and outcome domains, with effect sizes consistent with those observed in prior research testing in-person delivered and multi-modal psychological pain treatments. Thus, internet treatment delivery represents a tool to scale up access to evidence-based chronic pain treatments and to overcome widespread disparities in healthcare. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03687762.

Evaluating the benefits of a second pain treatment following a clinical trial.

OBJECTIVE: To examine the value of including an open label phase after a clinical trial of pain treatments by examining participant characteristics and potential benefits. METHOD: Secondary data analysis. Veterans with chronic pain who completed a randomized controlled trial (RCT) comparing hypnosis, mindfulness meditation, and pain education were invited to participate in an open label phase. Average and worst pain intensities, pain interference, and depression were assessed pre- and postopen label phase; global impressions of change and treatment satisfaction were assessed at postopen label phase only. RESULTS: Of those who were offered the open label phase, 40% (n = 68) enrolled. Enrollees were likely to be older, to have attended more sessions in the RCT, to be satisfied with their first treatment, and to perceive improvement in their ability to manage pain after the RCT. In the open label phase, depression and worst pain decreased across all three treatment conditions. No other improvements were observed. However, most Veterans perceived improvements in pain intensity, ability to manage pain, and pain interference, and were satisfied with the second intervention. CONCLUSIONS: There appears to be some value to adding an open label phase to the end of a trial of pain treatments. A substantial portion of study participants elected to participate and reported it to be beneficial. Exploring data from an open label phase can illuminate important aspects of patient experience, barriers to and facilitators of care, as well as treatment preferences. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Placebo effects contribute to brief online mindfulness interventions for chronic pain: results from an online randomized sham-controlled trial.

ABSTRACT: Mindfulness apps are becoming popular treatments for chronic pain and mental health, despite mixed evidence supporting their efficacy. Furthermore, it is unclear whether improvements in pain are due to mindfulness-specific effects or placebo effects because no trials have compared mindfulness against a sham control. The objective of this study was to compare mindfulness against 2 sham conditions with differing proximity to mindfulness to characterize the relative contributions of mindfulness-specific and nonspecific processes on chronic pain. We assessed changes in pain intensity and unpleasantness and mindfulness-specific and nonspecific pain-related processes in 169 adults with chronic or recurrent pain randomized to receive a single 20-minute online session of mindfulness, specific sham mindfulness, general sham mindfulness, or audiobook control. Mindfulness was not superior to shams for reducing pain intensity or unpleasantness, and no differential engagement of theorized mindfulness-specific processes was observed. However, mindfulness and both shams reduced pain unpleasantness relative to audiobook control, with expectancy most strongly associated with this effect. Sham specificity had no influence on expectancy or credibility ratings, pain catastrophizing, or pain effects. These findings suggest that improvements in chronic pain unpleasantness following a single session of online-delivered mindfulness meditation may be driven by placebo effects. Nonspecific treatment effects including placebo expectancy and pain catastrophizing may drive immediate pain attenuation rather than theorized mindfulness-specific processes themselves. Further research is needed to understand whether mindfulness-specific effects emerge after longer durations of online training.

Who Benefits the Most From Different Psychological Chronic Pain Treatments? An Exploratory Analysis of Treatment Moderators.

Different psychological chronic pain treatments benefit some individuals more than others. Understanding the factors that are associated with treatment response-especially when those factors differ between treatments-may inform more effective patient-treatment matching. This study aimed to identify variables that moderate treatment response to 4 psychological pain interventions in a sample of adults with low back pain or chronic pain associated with multiple sclerosis, spinal cord injury, acquired amputation, or muscular dystrophy (N = 173). The current study presents the results from secondary exploratory analyses using data from a randomized controlled clinical trial which compared the effects of 4 sessions of cognitive therapy (CT), hypnosis focused on pain reduction (HYP), hypnosis focused on changing pain-related cognitions and beliefs (HYP-CT), and a pain education control condition (ED). The analyses tested the effects of 7 potential treatment moderators. Measures of primary (pain intensity) and secondary (pain interference, depression severity) outcome domains were administered before and after the pain treatments, and potential moderators (catastrophizing, hypnotizability, and electroencephalogram (EEG)-assessed oscillation power across five bandwidths) were assessed at pre-treatment. Moderator effects were tested fitting regression analyses to pre- to post-treatment changes in the three outcome variables. The study findings, while preliminary, support the premise that pre-treatment measures of hypnotizability and EEG brain activity predict who is more (or less) likely to respond to different psychological pain treatments. If additional research replicates the findings, it may be possible to better match patients to their more individually suitable treatment, ultimately improving pain treatment outcomes. PERSPECTIVE: Pre-treatment measures of hypnotizability and EEG-assessed brain activity predicted who was more (or less) likely to respond to different psychological pain treatments. If these findings are replicated in future studies, they could inform the development of patient-treatment matching algorithms.

Effects of hypnosis, mindfulness meditation, and education for chronic pain on substance use in veterans: A supplementary analysis of a randomized clinical trial.

PURPOSE/OBJECTIVE: To examine the impact of three behavioral interventions for chronic pain on substance use. RESEARCH METHOD/DESIGN: Participants were 328 Veterans with chronic pain receiving care at one of two Veterans Affairs Medical Centers in the northwest United States. Participants were randomly assigned to one of three 8-week manualized in-person group treatments: (a) hypnosis (HYP), (b) mindfulness meditation (MM), or (c) active education control (ED). Substance use frequency was assessed using 10 individual items from the WHO-ASSIST, administered at baseline prior to randomization and at 3- and 6-month posttreatment. RESULTS: Baseline substance use (i.e., any use) in the past 3 months was reported by 22% (tobacco), 27% (cannabis), and 61% (alcohol) of participants. Use of all other substances assessed was reported by < 7% of participants. Results showed that MM, as compared to ED, significantly reduced risk of daily cannabis use by 85% and 81% at the 3- and 6-month posttreatment follow-ups, respectively, after adjusting for baseline use. HYP, as compared to ED, significantly reduced risk of daily cannabis use by 82% at the 6-month posttreatment follow-up after adjusting for baseline use. There was no intervention effect on tobacco or alcohol use at either posttreatment follow-up. CONCLUSIONS/IMPLICATIONS: HYP and MM for chronic pain may facilitate reductions in cannabis use, even when reducing such use is not a focus of treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Outcome Expectancies, Effects, and Mechanisms of Brief Training in Mindfulness Meditation vs. Loving-Kindness Meditation vs a Control Condition for Pain Management: A Randomized Pilot Study.

This study investigated the analgesic effects of a single session of mindfulness meditation (MM) and loving-kindness meditation (LKM) relative to a control. A total of 100 adults with chronic or current problematic pain completed a survey and were randomized to a 20-minute MM, LKM, or audiobook control. Co-primary outcomes of pain intensity and unpleasantness and mediators of mindfulness and self-compassion were assessed pre- and posttraining. Expectancies were assessed pretraining. Pain type (chronic vs current problematic) was a covariate. Relative to the control, higher expectancies were reported for MM and LKM (P < .001). MM (d = 0.41, P = .032) and LKM (d = 0.38, P = .027) had medium effects on pain intensity, with greater decreases than control (d = 0.05, P = .768). All conditions had small effects on unpleasantness. Mindful observing increased more within MM (d = 0.52, P = .022) and the control (d = 0.50, P = .011) than LKM (d = 0.12, P = .50); self-compassion increased more in LKM (d = 0.36, P = .042) than MM (d = 0.27, P = .201) and the control (d = 0.22, P = .249). The mediation models were nonsignificant. Pain type was a nonsignificant covariate. Overall, MM and LKM were associated with positive expectancies and small-medium pain intensity reductions, which did not differ by pain type. Although MM and LKM were associated with changes in theorized mediators, these changes did not underlie improvement.

Immediate Effects of Hypnosis, Mindfulness Meditation, and Prayer on Cold Pressor Outcomes: A Four-Arm Parallel Experimental Study.

Purpose: Previous research supports the usefulness of hypnosis (HYP), mindfulness meditation (MM), and prayer as pain self-management strategies in adults with chronic pain. However, their effects on acute pain have been less researched, and no previous head-to-head study compared the immediate effects of these three approaches on pain-related outcomes. This study compared the immediate effects of HYP, MM, and Christian prayer (CP) on pain intensity, pain tolerance, and stress as assessed by heart rate variability (HRV). Participants and Methods: A total of 232 healthy adults were randomly assigned to, and completed, a single 20-minute session of MM, SH, CP, or an attention control (CN), and underwent two cycles (one pre- and one post-intervention) of Cold Pressor Arm Wrap (CPAW). Sessions were audio-delivered. Participants responded to pre- and post-intervention pain intensity measurements. Pain tolerance (sec) was assessed during the CPAW cycles. HRV was assessed at baseline, and at pre- and post-intervention CPAW cycles. The study protocol was pre-registered at the ClinicalTrials.gov registry (NCT04491630). Results: Small within-group decreases in pain intensity and small increases in pain tolerance were found for HYP and MM from the pre- to the post-intervention. Small within-group improvements in the LH/HF ratio were also found for HYP. The exploratory between-group pairwise comparisons revealed a medium effect size effects of HYP on pain tolerance relative to the control condition. The effects of CP were positive, but small and not statistically significant. Only small to medium, though non-significant, Time × Group interaction effects were found. Conclusion: Study results suggest that single short-term HYP and MM sessions, but not biblical-based CP, may be useful for acute pain self-management, with HYP being the slightly superior option. Future research should compare the effects of different types of prayer and examine the predictors and moderators of these pain approaches' effects on pain-related outcomes.

Effects of hypnosis vs mindfulness meditation vs education on chronic pain intensity and secondary outcomes in veterans: a randomized clinical trial.

ABSTRACT: Effective, rigorously evaluated nonpharmacological treatments for chronic pain are needed. This study compared the effectiveness of training in hypnosis (HYP) and mindfulness meditation (MM) with an active education control (ED). Veterans (N = 328) were randomly assigned to 8 manualized, group-based, in-person sessions of HYP (n = 110), MM (n = 108), or ED (n = 110). Primary (average pain intensity [API]) and secondary outcomes were assessed at pretreatment, posttreatment, and 3 and 6 months posttreatment. Treatment effects were evaluated using linear regression, a generalized estimating equation approach, or a Fisher exact test, depending on the variable. There were no significant omnibus between-group differences in pretreatment to posttreatment change in API; however, pretreatment to posttreatment improvements in API and several secondary variables were seen for participants in all 3 conditions. Participation in MM resulted in greater decreases in API and pain interference at 6 months posttreatment relative to ED. Participation in HYP resulted in greater decreases in API, pain interference, and depressive symptoms at 3 and 6 months posttreatment compared with ED. No significant differences on outcomes between HYP and MM were detected at any time point. This study suggests that all 3 interventions provide posttreatment benefits on a range of outcomes, but the benefits of HYP and MM continue beyond the end of treatment, while the improvements associated with ED dissipate over time. Future research is needed to determine whether the between-group differences that emerged posttreatment are reliable, whether there are benefits of combining treatments, and to explore moderating and mediating factors.

How do placebo effects contribute to mindfulness-based analgesia? Probing acute pain effects and interactions using a randomized balanced placebo design.

ABSTRACT: Recent sham-controlled studies suggest placebo effects contribute to acute pain relief after mindfulness interventions. However, the specific effects of mindfulness processes and their interaction with placebo effects remain unclear. This study aimed to characterize the role of mindfulness and placebo processes underlying mindfulness-based pain attenuation. Both treatment (focused attention mindfulness vs sham) and instruction (told mindfulness vs told sham) were manipulated in a balanced placebo design. Changes in acute heat pain were evaluated in 153 healthy adults randomized to receive 6 × 20 minutes of 1 of 4 treatment by instruction interventions or no treatment. Participants receiving any intervention demonstrated improved pain outcomes (unpleasantness, intensity, and tolerance) relative to those receiving no treatment. The instruction manipulation increased expectation for pain relief in those told mindfulness relative to those told sham, but there were no main effects or interactions of treatment or instruction on pain outcomes. However, irrespective of actual intervention received, the belief of receiving mindfulness predicted increased pain threshold and tolerance, with expectancy fully mediating the effect on pain tolerance. These findings suggest a lack of specific effects of mindfulness and instruction on acute pain. Nonetheless, participants' expectancies and beliefs about the treatment they received did predict pain relief. Together with the overall improvement after any intervention, these findings suggest that expectancy and belief may play a stronger role in attenuating acute pain in novices following brief mindfulness interventions than the actual mindfulness-specific processes or instructions delivered.

Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine.

OBJECTIVE: Evaluate whether the benefits of Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) on headache disability differs among people with episodic and chronic migraine (CM). METHODS: This is a planned secondary analysis of a randomized clinical trial. After a 30-day baseline, participants were stratified by episodic (6-14 d/mo) and CM (15-30 d/mo) and randomized to 8 weekly individual sessions of MBCT-M or wait list/treatment as usual (WL/TAU). Primary outcomes (Headache Disability Inventory; Severe Migraine Disability Assessment Scale [scores ≥ 21]) were assessed at months 0, 1, 2, and 4. Mixed models for repeated measures tested moderation with fixed effects of treatment, time, CM, and all interactions. Planned subgroup analyses evaluated treatment*time in episodic and CM. RESULTS: Of 60 participants (MBCT-M N = 31, WL/TAU N = 29), 52% had CM. CM moderated the effect of MBCT-M on Severe Migraine Disability Assessment Scale, F(3, 205) = 3.68, p = 0.013; MBCT-M vs WL/TAU reduced the proportion of people reporting severe disability to a greater extent among people with episodic migraine (-40.0% vs -14.3%) than CM (-16.4% vs +8.7%). Subgroup analysis revealed MBCT-M (vs WL/TAU) significantly reduced Headache Disability Inventory for episodic (p = 0.011) but not CM (p = 0.268). CONCLUSIONS: MBCT-M is a promising treatment for reducing headache-related disability, with greater benefits in episodic than CM. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT02443519. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that MBCT-M reduces headache disability to a greater extent in people with episodic than CM.

A qualitative comparison of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain.

PURPOSE/OBJECTIVE: This study reports a qualitative analysis of patient experiences following cognitive therapy (CT), mindfulness meditation (MM), or mindfulness-based cognitive therapy (MBCT) for chronic low back pain (CLBP). It aimed to investigate the procedural elements reported by participants as important across these approaches, as well as the role of treatment-related change processes and common factors. Research Method/Design: A qualitative analysis of posttreatment semistructured interviews was conducted with participants who enrolled in a randomized controlled trial comparing MM, CT, and MBCT (N = 57 adults with CLBP). A thematic analysis of transcribed interviews was undertaken by two independent coders; emerging themes, subthemes, and direct quotes were collated, and thematic maps were created. RESULTS: Procedural elements that were both unique (e.g., "cognitive restructuring" in CT) and shared among the three treatments (e.g., "knowledge gained" on pain-related topics) were reported as important. Each treatment was associated with a small number of unique therapeutic processes that were consistent with theoretical tenets underlying the interventions (e.g., "staying in the present moment" in MM). A large number of shared processes and common factors also emerged as important across all three treatments. CONCLUSIONS/IMPLICATIONS: These first-person accounts provide insight into those participant-identified therapeutic procedures and change processes that were most valued by individuals completing cognitive and mindfulness-based interventions for CLBP. Early identification of treatment barriers and strategies to overcome these barriers is necessary. Further, therapeutic rapport and training participants in coping skills they themselves can use were critical, as was engendering changes in cognitive, emotional, and behavioral mechanisms. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Prayer as a pain intervention: protocol of a systematic review of randomised controlled trials.

BACKGROUND: Pain is a universal experience and the most common reason for seeking healthcare. Inadequate pain management negatively impacts numerous aspects of patient health. Multidisciplinary treatment programmes, including psychosocial interventions, are more useful for pain management than purely biomedical treatment alone. Recently, researchers showed increasing interest in understanding the role of spirituality/religiosity and spiritual/religious practices on pain experience, with engagement in religious practices, such as prayer, showing to positively impact pain experience in religious individuals. This systematic review will seek to summarise and integrate the existing findings from randomised controlled trials assessing the effects of prayer and prayer-based interventions on pain experience. METHODS: The systematic review procedures and its report will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement. Electronic searches in nine databases (Web of Science Core Collection, MEDLINE, SCIELO Citation Index, PubMed, Cochrane Central Register of Controlled Clinical Trial, PsycINFO, Scopus, LILACS and Open-SIGLE) will be performed to identify randomised controlled trials of prayer-based interventions. Two independent researchers will assess studies for inclusion and extract data from each paper. Risk of bias assessment will be assessed independently by two reviewers based on the Consolidated Standards of Reporting Trials statement. Qualitative synthesis of the body of research will be conducted using a narrative summary synthesis method. Meta-analysis will be limited to studies reporting on the same primary outcome. Formal searches are planned to start in June 2021. The final report is anticipated to be completed by September 2021. DISCUSSION: Findings will be useful to (1) understand the condition of our knowledge in this field and (2) provide evidence for prayer effectiveness in reducing pain intensity and pain-related stress and increasing pain tolerance in adults experiencing acute or chronic pain. PROSPERO REGISTRATION NUMBER: CRD42020221733.

Change in Brain Oscillations as a Mechanism of Mindfulness-Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain.

OBJECTIVE: Psychological treatments for chronic low back pain (CLBP) are effective. However, limited research has investigated their neurophysiological mechanisms. This study examined electroencephalography- (EEG-) assessed brain oscillation changes as potential mechanisms of cognitive therapy (CT), mindfulness-meditation (MM), and mindfulness-based cognitive therapy (MBCT) for CLBP. The a priori bandwidths of interest were changes in theta, alpha and beta power, measured at pre- and post-treatment. DESIGN: A secondary analysis of a clinical trial. SETTING: University of Queensland Psychology Clinic. SUBJECTS: Adults (N = 57) with CLBP who completed pre- and post-treatment EEG and pain outcome assessments. METHODS: EEG data were examined for five regions of interest (ROIs); the primary outcome was pain intensity. RESULTS: A significant reduction in theta (P=.015) and alpha (P=.006) power in the left frontal ROI across all treatments was found, although change in theta and alpha power in this region was not differentially associated with outcome across treatments. There were significant reductions in beta power in all five ROIs across all treatments (P≤.013). Beta power reduction in the central ROI showed a significant association with reduced pain intensity in MBCT only (P=.028). Changes in other regions were not statistically significant. CONCLUSIONS: These findings provide support for the capacity of psychological CLBP treatments to induce changes in brain activity. The reduced beta power in all five ROIs indicated that all three treatments engendered a state of lowered cortical arousal. The growing body of research in this area could potentially inform novel directions towards remedying central nervous system abnormalities associated with CLBP.

COPAHS Study: protocol of a randomised experimental study comparing the effects of hypnosis, mindfulness meditation, and spiritual practices on experimental pain in healthy adults.

BACKGROUND: There has been an increasing interest in studying the potential benefits of so-called complementary and alternative approaches for pain management, such as hypnosis and mindfulness-based interventions. More recently, researchers have been interested in studying the effects of spiritual practices on pain experience as well. These practices may increase pain tolerance, result in a positive re-appraisal of pain and influence other psychological variables that are known to be associated with pain experience. The purpose of this study is to evaluate and compare the immediate effects of self-hypnosis, mindfulness meditation, and a spiritual intervention relative to a control condition for increasing pain tolerance and reducing pain intensity and pain-related stress, in response to experimental painful stimulation. METHODS AND ANALYSIS: Recruitment is anticipated to start in November 2020. This is a randomised quantitative experimental mixed-design repeated-measures study with three assessment points: baseline (T0), pre-test (T1) and post-test (T2). Eligible healthy adults will be randomised to one of the four study conditions. Interventions will be a 20-minute audio-guided practice of either self-hypnosis, mindfulness meditation, or Christian prayer. Participants in the control group will not be instructed to use any specific strategy during the painful stimulation. Participants will be submitted to a first cycle of Cold Pressor Arm Wrap. They will then listen to a 20-minute audio recording inducing one of the three interventions, or, in the case of the control group, to a 20-minute audio recording of text from a natural history textbook. Primary outcomes are pain intensity and pain tolerance. Pain-related stress as measured by salivary cortisol level and heart rate variability are secondary outcomes. ETHICS AND DISSEMINATION: This study was approved by ISPA-University Institute's internal Ethics Committee for Research on 3rd December 2018 (reference I/010/12/2018). Findings will be published in peer-reviewed indexed journals and presented at conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT04491630). Stage: pre-results.

Pain-related beliefs, cognitive processes, and electroencephalography band power as predictors and mediators of the effects of psychological chronic pain interventions.

ABSTRACT: The current study used data from a clinical trial to identify variables that are associated with and/or mediate the beneficial effects of 4 psychological chronic pain treatments: one teaching patients self-hypnosis to reduce pain intensity (HYP), one teaching self-hypnosis to change thoughts about pain (hypnotic cognitive therapy [HYP-CT]), one teaching cognitive restructuring skills to change thoughts about pain (cognitive therapy [CT]), and one providing education about pain (ED; included as an active control condition). Of 17 possible mechanism variables examined, and with alpha not corrected for multiple comparisons, significant between-group differences were observed for 3. Two of these (changes in beliefs about control over pain and number of days of skill practice) were supported as mediators of the beneficial effects of HYP, CT, or HYP-CT, relative to ED. Six mechanism variables evidenced significant pretreatment to post-treatment changes in the sample as a whole, without showing significant between-group differences. Pretreatment to post-treatment changes in all 6 were associated with improvements in pain interference, pain intensity, or both. In addition, participant ratings of therapeutic alliance at post-treatment were associated significantly with improvements in both pain intensity and pain interference in the sample as a whole. Thus, of the 17 possible mediators examined, there were relatively few that served as mediators for the beneficial effects of specific treatments; a larger number of variables predicted treatment outcome overall. The extent to which these variables are treatment mediators (ie, are responsible for, rather than merely associated with, treatment-related improvements) will require further research.

Mindfulness-Based Analgesia or Placebo Effect? The Development and Evaluation of a Sham Mindfulness Intervention for Acute Experimental Pain.

OBJECTIVE: Meta-analyses indicate that mindfulness meditation is efficacious for chronic and acute pain, but most available studies lack active control comparisons. This raises the possibility that placebo-related processes may account, at least in part, for mindfulness effects. The objective of this study was to develop a closely matched sham mindfulness condition to establish whether placebo effects contribute to mindfulness-based interventions for pain. METHODS: We developed and validated a closely matched sham mindfulness intervention then compared it with 6 × 20-minute sessions of focused-attention mindfulness and a no-treatment condition in 93 healthy volunteers undergoing acute experimental heat pain. RESULTS: The sham mindfulness intervention produced equivalent credibility ratings and expectations of improvement as the mindfulness intervention but did not influence mindfulness-related processes. In contrast, mindfulness increased "observing" relative to no treatment but not sham. Mindfulness (F(1,88) = 7.06, p = .009, ηp2 = 0.07) and sham (F(1,88) = 6.47, p = .012, ηp2 = 0.07) moderately increased pain tolerance relative to no treatment, with no difference between mindfulness and sham (F(1,88) = 0.01, p = .92, ηp2 < 0.001). No differences were found for pain threshold. Similarly, neither mindfulness nor sham reduced pain intensity or unpleasantness relative to no treatment, although mindfulness reduced pain unpleasantness relative to sham (F(1,88) = 5.03, p = .027, ηp2 = 0.05). CONCLUSIONS: These results suggest that placebo effects contribute to changes in pain tolerance after mindfulness training, with limited evidence of specific effects of mindfulness training on pain unpleasantness relative to sham, but not no treatment. To disentangle the specific analgesic effects of mindfulness from placebo-related processes, future research should prioritize developing and incorporating closely matched sham conditions.Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12618001175268).

Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-based Cognitive Therapy for Chronic Low Back Pain.

OBJECTIVES: This study evaluated theoretically derived mechanisms and common therapeutic factors to test their role in accounting for pain-related outcome change during group-delivered cognitive therapy, mindfulness meditation, and mindfulness-based cognitive therapy for chronic low back pain. METHODS: A secondary analysis of a pilot randomized controlled trial was used to explore the primary mechanisms of pretreatment to posttreatment changes in pain control beliefs, mindful observing, and pain catastrophizing, and the secondary common factor mechanisms of therapeutic alliance, group cohesion, and amount of at-home skill practice during treatment. The primary outcome was pain interference; pain intensity was a secondary outcome. RESULTS: Large effect size changes in the 3 primary mechanisms and the outcome variables were found across the conditions. Across all 3 treatment conditions, change in pain control beliefs and pain catastrophizing were significantly associated with improved pain interference, but not pain intensity. Therapeutic alliance was significantly associated with pain intensity improvement and change in the therapy-specific mechanisms across the 3 conditions. Mindful observing, group cohesion, and amount of at-home practice were not significantly associated with changes in the outcomes. DISCUSSION: Cognitive therapy, mindfulness meditation, and mindfulness-based cognitive therapy for chronic low back pain were all associated with significant changes in the primary mechanisms to a similar degree. Change in perceived pain control and pain catastrophizing emerged as potential "meta-mechanisms" that might be a shared pathway that contributes to improved pain-related outcomes across treatments. Further, strong working alliance may represent a critical therapeutic process that both promotes and interacts with therapeutic techniques to influence outcome.

Moderators of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain: A Test of the Limit, Activate, and Enhance Model.

This study examined psychosocial pain treatment moderation in a secondary analysis of a trial that compared cognitive therapy (CT), mindfulness-meditation (MM), and mindfulness-based cognitive therapy (MBCT) for chronic low back pain (CLBP). The Limit, Activate, and Enhance (LA&E) model of moderation provided a framework for testing a priori hypotheses. Adult participants (N = 69) with CLBP completed a pretreatment assessment of hypothesized moderators: pain catastrophizing, brain state as assessed by electroencephalogram, mindful observing, and nonreactivity. Outcomes were pain interference, characteristic pain intensity, physical function, and depression, assessed at pre- and post-treatment. Moderation analyses found significant interaction effects, specifically: 1) higher and lower baseline pain catastrophizing was associated with greater improvement in pain intensity in MM and MBCT, respectively; 2) higher baseline theta power was associated with greater improvement in depression in MBCT and interfered with response to CT; 3) lower baseline nonreactivity was associated with greater improvement in physical function in MM while higher nonreactivity was associated with greater improvement in MBCT. The findings support the possibility that different patients are more or less likely to benefit from various treatments. Theory-driven moderation research has the capacity to inform the development of patient-treatment matching algorithms to optimize outcome. PERSPECTIVE: This study presents preliminary findings from theory-driven tests of the moderators of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain. The results of such analyses may inform the understanding of for whom various evidence-based psychosocial pain treatments may engender the most meaningful benefits.

Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol.

BACKGROUND: Chronic pain is one of the most prevalent and disabling symptoms associated with multiple sclerosis (MS). Individuals with MS are interested in nonpharmacologic pain management approaches. Cognitive-behavioral therapy (CBT) is efficacious in improving MS-related pain outcomes. Mindfulness-based cognitive therapy (MBCT) is a promising, alternative approach. Little is known about moderators of these treatments' outcomes, however. This article describes the study protocol for the first randomized controlled trial comparing MBCT, CBT, and usual care and examining treatment effect moderators in individuals with chronic pain and MS. METHODS: We will conduct a single-center, randomized, single blind, parallel-group trial comparing MBCT, CBT, and usual care in adults with MS and chronic pain. Both interventions will be delivered via eight group sessions using videoconferencing technology. Primary (average pain intensity) and secondary outcomes (including pain interference, depressive symptoms, fatigue, and sleep) will be assessed pre-treatment, mid-treatment, post-treatment, and at 6-month follow up. Potential treatment moderators will be assessed pre-treatment. We hypothesize that participants randomly assigned to MBCT or CBT will report significantly greater reductions in average pain intensity than participants assigned to usual care at post-treatment (primary study endpoint) and 6-month follow up. We also hypothesize that mindfulness, pain catastrophizing, and behavioral activation pre-treatment will moderate response to both active treatments, but not response to usual care. DISCUSSION: Findings will provide important new information about the efficacy and moderators of two nonpharmacologic pain management approaches delivered using technology to overcome common barriers to treatment access. The knowledge gained may lead to better patient-treatment matching and, ultimately, better pain treatment outcomes in MS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03782246. Registered on 20 December 2018.

A Pilot Randomized Controlled Trial Comparing Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain.

OBJECTIVE: This pilot trial compared the feasibility, tolerability, acceptability, and effects of group-delivered mindfulness meditation (MM), cognitive therapy (CT), and mindfulness-based cognitive therapy (MBCT) for chronic low back pain (CLBP). SETTING: University of Queensland Psychology Clinic. SUBJECTS: Participants were N = 69 (intent-to-treat [ITT] sample) adults with CLBP. DESIGN: A pilot, assessor-blinded randomized controlled trial. METHODS: Participants were randomized to treatments. The primary outcome was pain interference; secondary outcomes were pain intensity, physical function, depression, and opioid medication use. The primary study end point was post-treatment; maintenance of gains was evaluated at three- and six-month follow-up. RESULTS: Ratings of acceptability, and ratios of dropout and attendance showed that MBCT was acceptable, feasible, and well tolerated, with similar results found across conditions. For the ITT sample, large improvements in post-treatment scores for pain interference, pain intensity, physical function, and depression were found (P < 0.001), with no significant between-group differences. Analysis of the follow-up data (N = 43), however, revealed that MBCT participants improved significantly more than MM participants on pain interference, physical function, and depression. The CT group improved more than MM in physical function. The MBCT and CT groups did not differ significantly on any measures. CONCLUSIONS: This is the first study to examine MBCT for CLBP management. The findings show that MBCT is a feasible, tolerable, acceptable, and potentially efficacious treatment option for CLBP. Further, MBCT, and possibly CT, could have sustained benefits that exceed MM on some important CLBP outcomes. A future definitive randomized controlled trial is needed to evaluate these treatments and their differences.