A synthesis of meta-analyses of mindfulness-based interventions in pain.

ABSTRACT: Mindfulness interventions have become popular in recent decades, with many trials, systematic reviews, and meta-analyses of the impact of mindfulness-based interventions (MBIs) on pain. Although many meta-analyses provide support for MBIs, the results are more mixed than they at first appear. The aim of this umbrella review was to determine the strength of evidence for MBIs by synthesizing available meta-analyses in pain. We conducted a systematic search in 5 databases and extracted data from published meta-analyses as the unit of analysis. For each outcome, we reported the range of effect sizes observed across studies and identified the largest meta-analysis as the "representative" study. We separately analysed effect sizes for different pain conditions, different types of MBIs, different control groups, and different outcomes. We identified 21 meta-analyses that included 127 unique studies. According to Assessment of Multiple Systematic Review ratings, the meta-analyses ranged from very strong to weak. Overall, there was an impact of MBIs on pain severity, anxiety, and depression but not pain interference or disability. When conditions were considered in isolation, only fibromyalgia and headache benefited significantly from MBIs. Mindfulness-based interventions were more efficacious for pain severity than passive control conditions but not active control conditions. Only pain severity and anxiety were affected by MBIs at follow-up. Overall, our results suggest that individual meta-analyses of MBIs may have overestimated the efficacy of MBIs in a range of conditions. Mindfulness-based interventions likely have a role in pain management but should not be considered a panacea.

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.

Randomised controlled trial of cognitive behaviour therapy versus mindfulness for people with rheumatoid arthritis with and without a history of recurrent depression: study protocol and design.

INTRODUCTION: Psychosocial treatments have been shown to benefit people with rheumatoid arthritis (RA) on various outcomes. Two evidence-based interventions are cognitive behavioural therapy (CBT) and mindfulness-based stress reduction (MBSR). However, these interventions have been compared only once. Results showed that CBT outperformed MBSR on some outcomes, but MBSR was more effective for people with RA with a history of recurrent depression, with efficacy being moderated by history of depressive episodes. However, this was a post-hoc finding based on a small subsample. We aim to examine whether a history of recurrent depression will moderate the relative efficacy of these treatments when delivered online. METHODS AND ANALYSIS: This study is a randomised controlled trial comparing CBT and MBSR delivered online with a waitlist control condition. History of recurrent depressive episodes will be assessed at baseline. The primary outcome will be pain interference. Secondary outcomes will include pain intensity, RA symptoms, depressive symptoms and anxiety symptoms. Outcome measures will be administered at baseline, post-treatment and at 6 months follow-up. We aim to recruit 300 participants, and an intention-to-treat analysis will be used. Linear mixed models will be used, with baseline levels of treatment outcomes as the covariate, and group and depressive status as fixed factors. The results will demonstrate whether online CBT and MBSR effectively improve outcomes among people with RA. Importantly, this trial will determine whether one intervention is more efficacious, and whether prior history of depression moderates this effect. ETHICS AND DISSEMINATION: The trial has been approved by the Human Research Ethics Committee of the University of Sydney (2021/516). The findings will be subject to publication irrespective of the final results of the study, and based on the outcomes presented in this protocol. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000997853p).

A randomized controlled trial of a web-based mindfulness programme for people with MS with and without a history of recurrent depression.

BACKGROUND: Evidence shows small positive effects associated with psychological treatments for people with multiple sclerosis (PwMS). In a recent meta-analysis, the treatment with the largest effect size was a mindfulness-based intervention (MBI). OBJECTIVES: We aimed to determine whether an Internet-delivered MBI was beneficial for PwMS. Furthermore, we aimed to investigate history of recurrent depression as a moderator of treatment outcome. METHODS: Participants (N = 132) were assessed based on whether they had a history of recurrent depression, then stratified and randomized to MBI or waitlist. Outcomes were assessed at baseline, post-intervention, and 3 and 6 months. RESULTS: The MBI group reported significantly improved depressive symptoms (primary outcome) compared with the waitlist (p = 0.046, Cohen's d = 0.39). Those with a history of recurrent depression benefitted significantly more than those without (p = 0.034, d = 0.66). There were benefits for health-related quality of life (HRQoL) in the MBI, irrespective of depression history (p = 0.009, d = 0.5). Pain interference was less overall in the MBI group (p < 0.001, d = 0.2), but change over time did not differ from waitlist. There were no treatment effects for anxiety, pain severity or fatigue. CONCLUSION: The Internet-delivered MBI significantly improved depressive symptoms and HRQoL in PwMS. For depression, the benefits were greater for those with a history of recurrent depression. TRIAL REGISTRATION: ACTRN12618001260213, available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375598.

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.

Development of a Web-Based Mindfulness Program for People With Multiple Sclerosis: Qualitative Co-Design Study.

BACKGROUND: Mindfulness-based stress reduction is an efficacious treatment for people with chronic health problems; however, it is highly intensive and time-consuming, which is a barrier for service provision. OBJECTIVE: This study aims to develop an internet-delivered adapted version of mindfulness-based stress reduction for people with multiple sclerosis to make the intervention more accessible. METHODS: We co-designed a web-based mindfulness program with end users, that is, people with multiple sclerosis (N=19). Iterative feedback was also collected from a subsample of the initial group of end users (n=11), and the program was reviewed by experts (n=8). RESULTS: We identified three main themes common to people with multiple sclerosis: dealing with uncertainty and fears for the future, grief and loss, and social isolation. These themes were incorporated into narratives throughout the program. People with multiple sclerosis who reviewed the program gave feedback that the program was relatable, feasible, and acceptable. Experts agreed that the program appropriately represented the main tenets of mindfulness. Iterative feedback was used to further refine the program. CONCLUSIONS: The web-based mindfulness program that we developed was viewed positively by both experts and end users. The program reflects common concerns for people with multiple sclerosis and has the potential to meet important unmet psychological needs. A randomized controlled trial was planned to determine the efficacy of the program.

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).

The efficacy of mindfulness-based interventions in acute pain: a systematic review and meta-analysis.

Recent meta-analyses have shown mindfulness-based interventions (MBIs) to be effective for chronic pain, but no pooled estimates of the effect of MBIs on acute pain are available. This meta-analysis was conducted to fill that gap. A literature search was conducted in 4 databases. Articles were eligible if they reported on randomized controlled trials of MBIs for people with acute pain and one of the following outcomes: pain severity, pain threshold, pain tolerance, or pain-related distress. Two authors independently extracted the data, assessed risk of bias, and provided GRADE ratings. Twenty-two studies were included. There was no evidence of an effect of MBIs on the primary outcome of pain severity in clinical {Hedges' g = 0.52; (95% confidence interval [CI] -0.241 to 1.280)} or experimental settings (Hedges' g = 0.04; 95% CI [-0.161 to 0.247]). There was a beneficial effect of MBIs on pain tolerance (Hedges' g = 0.68; 95% CI [0.157-1.282]) and pain threshold (Hedges' g = 0.72; 95% CI [0.210-1.154]) in experimental studies. There was no evidence of an effect of MBIs compared to control for pain-related distress in clinical (Hedges' g = 0.16; 95% CI [-0.018 to 0.419]) or experimental settings (Hedges' g = 0.44; 95% CI [-0.164 to 0.419]). GRADE assessment indicated that except for pain tolerance, the data were of low or very low quality. There is moderate evidence that MBIs are efficacious in increasing pain tolerance and weak evidence for pain threshold. However, there is an absence of good-quality evidence for the efficacy of MBIs for reducing the pain severity or pain-related distress in either clinical or experimental settings.

Psychological intervention (ConquerFear) for treating fear of cancer recurrence: mediators and moderators of treatment efficacy.

PURPOSE: ConquerFear is an efficacious intervention for fear of cancer recurrence (FCR) that demonstrated greater improvements than an attention control (relaxation training) in a randomized controlled trial. This study aimed to determine mediators and moderators of the relative treatment efficacy of ConquerFear versus relaxation. METHODS: One hundred and fifty-two cancer survivors completed 5 therapy sessions and outcome measures before and after intervention and at 6 months' follow-up. We examined theoretically relevant variables as potential mediators and moderators of treatment outcome. We hypothesized that metacognitions and intrusions would moderate and mediate the relationship between treatment group and FCR level at follow-up. RESULTS: Only total FCR score at baseline moderated treatment outcome. Participants with higher levels of FCR benefited more from ConquerFear relative to relaxation on the primary outcome. Changes in metacognitions and intrusive thoughts about cancer during treatment partially mediated the relationship between treatment group and FCR. CONCLUSIONS: These results show that ConquerFear is relatively more effective than relaxation for those with overall higher levels of FCR. The mediation analyses confirmed that the most likely mechanism of treatment efficacy was the reduction in unhelpful metacognitions and intrusive thoughts during treatment, consistent with the theoretical framework underpinning ConquerFear. IMPLICATIONS FOR CANCER SURVIVORS: ConquerFear is a brief, effective treatment for FCR in cancer survivors with early-stage disease. The treatment works by reducing intrusive thoughts about cancer and changing beliefs about worry and is particularly helpful for people with moderate to severe FCR.

The evaluation of an online mindfulness program for people with multiple sclerosis: study protocol.

BACKGROUND: Multiple sclerosis (MS) is a neurological disease of the central nervous system and is associated with many psychosocial symptoms that are difficult to manage including low mood, anxiety, fatigue and pain, as well as low health-related quality of life. Internet-based psychosocial interventions that use mindfulness-based approaches are gathering much attention in recent literature, particularly in the treatment of chronic illnesses. However, no large randomized controlled trials have been done examining the efficacy of such interventions for people with MS (PwMS). METHODS/DESIGN: This study is a randomised controlled trial of an online mindfulness-based intervention (MBI) for PwMS. Participants will be randomised to receive either the MBI or offered the intervention after a waiting period. All participants will be assessed to determine whether they have a history of recurrent depressive disorder. The primary outcome will be severity of depression, according to the Centre of Epidemiology Depression Scale. Secondary outcomes will be anxiety severity, fatigue, pain and quality of life. Assessments will be conducted pre, post-treatment, at three and six-month follow-up. The online mindfulness-based program was developed in collaboration with end-users (n = 19 PwMS) who gave feedback about what would be feasible and acceptable, and the draft program was reviewed by both experts and patients. DISCUSSION: Multiple sclerosis is the most common acquired chronic neurological disease amongst young adults and is associated with a range of symptoms that can be difficult to cope with. In face-to-face interventions, a MBI demonstrated the largest effect in a recent meta-analysis of psychological treatments for PwMS, but MBIs for PwMS have not been delivered online. Hence, this trial will confirm whether MBIs can be efficacious when delivered online. A range of symptoms are assessed as outcomes so that the nature of benefits associated with the online MBI can be ascertained. TRIAL REGISTRATION: ACTRN12618001260213 . Date of Registration: 25/07/2018.

The relative efficacy of mindfulness versus distraction: The moderating role of attentional bias.

BACKGROUND: This study investigated whether the ability to disengage quickly from pain-related stimuli moderated the relative efficacy of a mindfulness-based intervention versus distraction in response to an experimental pain task. METHODS: Participants (n = 100) completed a dot probe task with eye tracking and were then randomized (2:2:1) to receive a mindfulness-based interoceptive exposure task (MIET), distraction instructions or no instructions (control group) before engaging in the cold pressor test. RESULTS: Participants who were allocated to the MIET condition reported a significantly higher pain threshold and distress than the distraction group, although not significantly higher than the control group. Those in the MIET group had improved tolerance compared to both the distraction and control groups. Difficulty disengaging from pain-related stimuli, as measured by the duration of the first fixation on sensory words, was found to moderate the relative efficacy of mindfulness versus distraction in terms of pain threshold and distress, but not tolerance. Those with difficulty disengaging from sensory pain words benefited less from the MIET. Duration of first fixation on sensory and affective pain words were highly correlated, and duration of first fixation on affective pain words also moderated the relative efficacy of MIET and distraction on threshold, but not distress. CONCLUSIONS: These results show that a single brief session of a mindfulness task was sufficient to change an acute pain experience in comparison with a distraction task, and that those who disengaged quickly from pain words benefited most. SIGNIFICANCE: This study demonstrated the efficacy of a novel, exposure-based mindfulness technique for pain tolerance and showed that those who disengaged easily from pain stimuli benefited most. This brief task could be clinically useful, particularly for those who are not overly focused on their pain symptoms.

Cognitive behaviour therapy reduces dyspnoea ratings in patients with chronic obstructive pulmonary disease (COPD).

There is evidence that psychological factors contribute to the perception of increased difficulty of breathing in patients with chronic obstructive pulmonary disease (COPD), and increase morbidity. We tested the hypothesis that cognitive behaviour therapy (CBT) decreases ratings of perceived dyspnoea in response to resistive loading in patients with COPD. From 31 patients with COPD, 18 were randomised to four sessions of specifically targeted CBT and 13 to routine care. Prior to randomisation, participants were tested with an inspiratory external resistive load protocol (loads between 5 and 45cmH2O/L/s). Six months later, we re-measured perceived dyspnoea in response to the same inspiratory resistive loads and compared results to measurements prior to randomisation. There was a significant 17% reduction in dyspnoea ratings across the loads for the CBT group, and no reduction for the routine care group. The decrease in ratings of dyspnoea suggests that CBT to alleviate breathing discomfort may have a role in the routine treatment of people with COPD.

Effect of EMG biofeedback compared to applied relaxation training with chronic, upper extremity cumulative trauma disorders.

This study examined the relative effectiveness of EMG biofeedback, applied relaxation training and a combined procedure in the management of chronic, upper extremity cumulative trauma disorder. Forty-eight patients with a history of about 5-6 years of upper extremity pain were randomly assigned to 1 of 4 treatment conditions, namely applied relaxation training, EMG biofeedback, a combined approach or a wait-list control. Treatments were conducted on an individual basis, twice per week for 4 weeks. Patients in all 3 treatment conditions showed significant short-term reductions in pain and psychopathology in comparison to the wait-list group who showed minimal change. Six-month follow-up data were obtained for patients in the treatment conditions, but not the wait-list group. There was some evidence of relapse on measures of depression, anxiety and pain beliefs for treated patients during the 6-month follow-up period, although measures remained significantly below pre-treatment levels for most outcome indices. Self-monitored pain continued to decrease for the treatment groups through follow-up. Contrary to predictions, however, the strongest short-term treatment benefits were shown by patients receiving applied relaxation training on measures of pain, distress, interference in daily living, depression and anxiety. By 6-month follow-up, differences between treatment groups were no longer evident.