Dataset Information

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

ABSTRACT: Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.Randomized, 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).CBT (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.Coprimary 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.There 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.Among 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.clinicaltrials.gov Identifier: NCT01467843.

SUBMITTER: Cherkin DC

PROVIDER: S-EPMC4914381 | biostudies-literature | 2016 Mar 22-29

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Cherkin Daniel C DC Sherman Karen J KJ Balderson Benjamin H BH Cook Andrea J AJ Anderson Melissa L ML Hawkes Rene J RJ Hansen Kelly E KE Turner Judith A JA

JAMA 20160301 12

<h4>Importance</h4>Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.<h4>Objective</h4>To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.<h4>Design, setting, and participants</h4>Randomized, 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 enroll ...[more]

PMID: 27002445

Similar Datasets

Project description:BackgroundChronic back pain is prevalent in Brazil, leading to enormous healthcare costs and social burdens. It also disproportionately affects low-income and less-healthy people.ObjectivesThis study examines the associations of chronic back pain with biological, psychological, and social factors; how it limits usual activities; and how chronic back pain influences the use of treatment services.MethodsUsing Brazil's National Health Survey (PNS-2019), multivariate logistic regressions were conducted to examine how biological, psychological, and social factors correlate with chronic back pain, limitations on usual activities, and pain treatment.ResultsPNS-2019 data showed that 23.4% (95% CI 22.8-24.0) of Brazilian adults aged over 20 reported back pain. A higher prevalence of chronic back pain was associated with biological factors (older age, being female, overweight or obese, current smoking, and having more chronic conditions), lower social conditions (low education, low per capita household income, non-married, and living in rural areas), and poor psychological health (more depressive symptoms). Chronic back pain is more likely to limit usual activities among those with low social conditions (lower education, lower income), poor physical and behavioral health (obese, current smokers, and those with a greater number of chronic conditions), and worse psychological health (more depressive symptoms). However, married people and those who do not consume alcohol were also more likely to report limited activities. Among those with back pain, 68% received at least one form of treatment. Those with intense limitations on their usual activities were 2.2 times as likely to report treatment. People with higher social conditions (higher income, college education, and private health insurance) were more likely to receive treatment.ConclusionThe results show significant biological, psychological, and social disparities in the prevalence of chronic back pain in Brazil. The findings point to the need for tailored policies and prevention programs with attention to vulnerable groups. Even though Brazil has universal health care, those with better socioeconomic conditions are more likely to receive treatment.

Project description:ImportanceChronic back pain (CBP) is a leading cause of disability, and treatment is often ineffective. Approximately 85% of cases are primary CBP, for which peripheral etiology cannot be identified, and maintenance factors include fear, avoidance, and beliefs that pain indicates injury.ObjectiveTo test whether a psychological treatment (pain reprocessing therapy [PRT]) aiming to shift patients' beliefs about the causes and threat value of pain provides substantial and durable pain relief from primary CBP and to investigate treatment mechanisms.Design, setting, and participantsThis randomized clinical trial with longitudinal functional magnetic resonance imaging (fMRI) and 1-year follow-up assessment was conducted in a university research setting from November 2017 to August 2018, with 1-year follow-up completed by November 2019. Clinical and fMRI data were analyzed from January 2019 to August 2020. The study compared PRT with an open-label placebo treatment and with usual care in a community sample.InterventionsParticipants randomized to PRT participated in 1 telehealth session with a physician and 8 psychological treatment sessions over 4 weeks. Treatment aimed to help patients reconceptualize their pain as due to nondangerous brain activity rather than peripheral tissue injury, using a combination of cognitive, somatic, and exposure-based techniques. Participants randomized to placebo received an open-label subcutaneous saline injection in the back; participants randomized to usual care continued their routine, ongoing care.Main outcomes and measuresOne-week mean back pain intensity score (0 to 10) at posttreatment, pain beliefs, and fMRI measures of evoked pain and resting connectivity.ResultsAt baseline, 151 adults (54% female; mean [SD] age, 41.1 [15.6] years) reported mean (SD) pain of low to moderate severity (mean [SD] pain intensity, 4.10 [1.26] of 10; mean [SD] disability, 23.34 [10.12] of 100) and mean (SD) pain duration of 10.0 (8.9) years. Large group differences in pain were observed at posttreatment, with a mean (SD) pain score of 1.18 (1.24) in the PRT group, 2.84 (1.64) in the placebo group, and 3.13 (1.45) in the usual care group. Hedges g was -1.14 for PRT vs placebo and -1.74 for PRT vs usual care (P < .001). Of 151 total participants, 33 of 50 participants (66%) randomized to PRT were pain-free or nearly pain-free at posttreatment (reporting a pain intensity score of 0 or 1 of 10), compared with 10 of 51 participants (20%) randomized to placebo and 5 of 50 participants (10%) randomized to usual care. Treatment effects were maintained at 1-year follow-up, with a mean (SD) pain score of 1.51 (1.59) in the PRT group, 2.79 (1.78) in the placebo group, and 3.00 (1.77) in the usual care group. Hedges g was -0.70 for PRT vs placebo (P = .001) and -1.05 for PRT vs usual care (P < .001) at 1-year follow-up. Longitudinal fMRI showed (1) reduced responses to evoked back pain in the anterior midcingulate and the anterior prefrontal cortex for PRT vs placebo; (2) reduced responses in the anterior insula for PRT vs usual care; (3) increased resting connectivity from the anterior prefrontal cortex and the anterior insula to the primary somatosensory cortex for PRT vs both control groups; and (4) increased connectivity from the anterior midcingulate to the precuneus for PRT vs usual care.Conclusions and relevancePsychological treatment centered on changing patients' beliefs about the causes and threat value of pain may provide substantial and durable pain relief for people with CBP.Trial registrationClinicalTrials.gov Identifier: NCT03294148.

Project description:BackgroundChronic low back pain is a common and sometimes disabling condition, and mindfulness-based stress reduction is recommended as a first line of therapy. This study tested whether different descriptions of mindfulness training altered based on influential intervention characteristics increased adoption intentions.MethodsPeople with chronic low back pain (n = 452) were randomized to review one of four mindfulness training descriptions in an online survey using a 2 × 2 factorial design. The first factor was evidence strength and quality with relative advantage (ER). The second factor was adaptability, trialability, complexity, and design quality and packaging (AD). Each factor had two levels: a description of standardized mindfulness training that described each intervention characteristic and a patient-centered description emphasizing flexibility and patient testimonials. The primary outcomes were intentions to try mindfulness training and practice mindfulness at home. Using structural equation modeling with a bootstrapped distribution, we tested six mediators, three of which are Theory of Planned Behavior predictors of intention-self-efficacy, norms, and attitudes- and the other three are predictors of adoption-feasibility, appropriateness, and acceptability.ResultsOverall, the mindfulness training descriptions were not associated with an increase in intentions compared to the classic vignette (11/12 p's > 0.05). Most descriptions were unrelated to mediators except the classic ER with patient-centered AD was associated with higher self-efficacy/control and feasibility (p's ≤ 0.05; standardized effect range: 0.111-0.125). Self-efficacy/control (training standardized coefficient: 0.531, home: 0.686), norms (training: 0.303, home: 0.256), and attitudes (training: 0.316, home: 0.293) were all positively associated with intentions to adopt mindfulness training and home practice. Feasibility (training: 0.185; home: 0.293) and acceptability (training: 0.639; home: 0.554) were positively related to intentions to adopt mindfulness training. Appropriateness was related to intentions to adopt home practice (0.187) but not mindfulness training (0.100). None of the indirect effects from experimental group to intentions was significant (all p's > 0.05).ConclusionsSelf-efficacy/control and acceptability may be key mediators for increasing patient adoption of mindfulness. Because experimental manipulation did not substantially change intentions to adopt mindfulness, the presentation and delivery of MBSR may need to be tailored to the individual patient's needs rather than a specific format for chronic low back pain.

Project description:Importance:Brief cognitive behavioral therapy (BCBT) is a clinically effective intervention for reducing risk of suicide attempts among suicidal US Army soldiers. However, because specialized treatments can be resource intensive, more information is needed on costs and benefits of BCBT compared with existing treatments. Objective:To evaluate the cost-effectiveness of BCBT compared with treatment as usual for suicidal soldiers in the US Army. Design, Setting, and Participants:A decision analytic model compared effects and costs of BCBT vs treatment as usual from a US Department of Defense (DoD) perspective. Model input data were drawn from epidemiologic data sets and a clinical trial among suicidal soldiers conducted from January 31, 2011, to April 3, 2014. Data were analyzed from July 3, 2018, to March 25, 2019. Interventions:The strategies compared were treatment as usual alone vs treatment as usual plus 12 individual BCBT sessions. Treatment as usual could include a range of pharmacologic and psychological treatment options. Main Outcomes and Measures:Costs in 2017 US dollars, suicide attempts averted (self-directed behavior with intent to die, but with nonfatal outcome), suicide deaths averted, and incremental cost-effectiveness ratios, assuming a 2-year time horizon for treatment differences but including lifetime costs. Results:In the base-case analysis, BCBT was expected to avert approximately 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients treated than treatment as usual. Sensitivity analyses assuming a range of treatment effects showed BCBT to be cost saving in most scenarios. Using the federal discount rate, the DoD was estimated to save from $15?000 to $16?630 per patient with BCBT vs treatment as usual. In a worst-case scenario (ie, assuming the weakest plausible BCBT effect sizes), BCBT cost an additional $1910 to $2250 per patient compared with treatment as usual. Conclusions and Relevance:Results suggest BCBT may be a cost-saving intervention for suicidal active-duty soldiers. The costs of ensuring treatment fidelity would also need to be considered when assessing the implications of disseminating BCBT across the entire DoD.

Dataset Information

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Publications

Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets