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Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioral therapy for the treatment and management of chronic pain disorders: protocol for a systematic review and meta-analysis with indirect comparisons.

ABSTRACT: BACKGROUND: Chronic pain disorders impact the physical, psychological, social, and financial well-being of between 10%-30% of Canadians. The primary aims of psychological interventions targeting chronic pain disorders are to reduce patients' pain-related disability and to improve their quality of life. Cognitive behavioral therapy (CBT) is the prevailing treatment for chronic pain, however mindfulness-based stress reduction (MBSR) has displayed promise as an alternative treatment option. The objective of this systematic review and meta-analysis is to compare MBSR to CBT in their relative ability to reduce pain-related disability and intensity, to alleviate emotional distress, and to improve global functioning in chronic pain patients. METHODS/DESIGN: We will conduct a systematic review with meta-analyses to compare MBSR to CBT in the treatment of chronic pain disorders in adults. We will report our review according to the recommendations provided by the PRISMA statement. Randomized studies will be included and the literature search will comprise Ovid MEDLINE®, Ovid MEDLINE® In-Process & Other Non-Indexed Citations, Embase Classic+Embase, PsycINFO, the Cochrane Library on Wiley, including CENTRAL, Cochrane Database of Systematic Reviews, DARE, and HTA. Study selection and data extraction will be conducted by independent investigators and in duplicate. Outcomes of interest will include pain interference, pain intensity, emotional functioning, and patient global impression of change. The Cochrane risk of bias tool will be used to assess risk of bias of included studies. As we anticipate that scales used to measure participant responses will be related but varied from study to study, standardized mean differences will be used to compare effect sizes between treatment modalities. Given the possibility of little or no head-to-head evidence comparing MBSR with CBT, we will use indirect treatment comparison methodology to assess the relative effectiveness of these interventions. DISCUSSION: The findings from this study will assist patients and treatment providers to make informed decisions regarding evidence-based treatment selection for chronic pain disorders. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014009356.

SUBMITTER: Hatchard T

PROVIDER: S-EPMC4230908 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioral therapy for the treatment and management of chronic pain disorders: protocol for a systematic review and meta-analysis with indirect comparisons.

Hatchard Taylor T Lepage Chris C Hutton Brian B Skidmore Becky B Poulin Patricia A PA

Systematic reviews 20141110

<h4>Background</h4>Chronic pain disorders impact the physical, psychological, social, and financial well-being of between 10%-30% of Canadians. The primary aims of psychological interventions targeting chronic pain disorders are to reduce patients' pain-related disability and to improve their quality of life. Cognitive behavioral therapy (CBT) is the prevailing treatment for chronic pain, however mindfulness-based stress reduction (MBSR) has displayed promise as an alternative treatment option. ...[more]

PMID: 25387478

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Project description:BackgroundNonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated.ObjectiveIn response to these knowledge gaps, the Stanford Center for Low Back Pain-a collaborative, National Institutes of Health P01-funded, multidisciplinary research center-was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments.MethodsThe multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy.ResultsParticipant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021.ConclusionsThis center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments.Trial registrationClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475.International registered report identifier (irrid)PRR1-10.2196/37823.

Project description: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.

Project description:ImportanceMindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.ObjectiveTo evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.Design, setting, and participantsRandomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113).InterventionsCBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.Main outcomes and measuresCoprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.ResultsThere were 342 randomized participants, the mean (SD) [range] age was 49.3 (12.3) [20-70] years, 224 (65.7%) were women, mean duration of back pain was 7.3 years (range, 3 months-50 years), 123 (53.7%) attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks, and 290 (84.8%) completed the study at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%) (overall P = .04; relative risk [RR] for MBSR vs usual care, 1.37 [95% CI, 1.06-1.77]; RR for MBSR vs CBT, 0.95 [95% CI, 0.77-1.18]; and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group (overall P = .01; RR for MBSR vs usual care, 1.64 [95% CI, 1.15-2.34]; RR for MBSR vs CBT, 1.03 [95% CI, 0.78-1.36]; and RR for CBT vs usual care, 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.Conclusions and relevanceAmong adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.Trial registrationclinicaltrials.gov Identifier: NCT01467843.

Dataset Information

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioral therapy for the treatment and management of chronic pain disorders: protocol for a systematic review and meta-analysis with indirect comparisons.

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Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioral therapy for the treatment and management of chronic pain disorders: protocol for a systematic review and meta-analysis with indirect comparisons.

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