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.

Validation of the Brazilian Version of the Langer Mindfulness Scale.

Background and Purpose: The Langer Mindfulness Scale (LMS) is distinguished from other mindfulness scales by its dimensions, which are closely related to the awareness and experience of novelty, and by being a scale derived from a cognitive perspective of information processing. There are no mindfulness instruments of this type available in Brazil. Therefore, this study aimed to carry out a translation and cultural adaptation of the LMS into Brazilian Portuguese and to validate and assess the internal consistency and convergent construct validity of the translated instrument. Methods: The study had two distinct stages: (a) translation and cultural adaptation of the LMS into Brazilian Portuguese and (b) validation of the adapted instrument using a sample of 543 participants. Results: The Brazilian version of the LMS demonstrated acceptable internal consistency, with confirmatory factor analysis supporting the original four-factor model. Correlations between LMS, and the Five Facets of Mindfulness Questionnaire and the Mindfulness Attention Awareness Scale were statistically significant and in the expected directions. Conclusions: Our findings suggest that the Brazilian version of LMS, with its four dimensions, presents acceptable psychometric properties and seems to be a reliable and valid instrument for assessing the state of mindfulness in a Brazilian cultural context.

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 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.

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.

Chamomile Gel versus Urea Cream to Prevent Acute Radiation Dermatitis in Head and Neck Cancer Patients: Results from a Preliminary Clinical Trial.

We assessed safety and potential efficacy of a chamomile gel compared with urea cream to prevent acute radiation dermatitis in head and neck cancer patients. We assessed safety and potential efficacy of the chamomile gel in escalating concentrations of 2.50%, 5.00% and 8.35% of chamomile. Concentration of 8.35% was chosen for a randomized trial comparing chamomile gel (8.35%) with urea cream (n = 24 per group), for potential efficacy to delay or prevent radiation dermatitis in these patients. Preliminary results demonstrate a delayed onset of dermatitis, with onset of Grade 2 dermatitis at 5.1 (1.3) weeks in the chamomile group and 4.5 (1.3) weeks in the urea group (effect size of 0.46). Itching, burning and hyperpigmentation were more frequently reported in the urea group. Results indicates a potential efficacy of the chamomile gel. Further studies are needed to confirm the effect of the chamomile gel in reducing or delaying the occurrence of radiation dermatitis.

Effects of hypnosis, cognitive therapy, hypnotic cognitive therapy, and pain education in adults with chronic pain: a randomized clinical trial.

Chronic pain is a significant health problem worldwide with limited pharmacological treatment options. This study evaluated the relative efficacy of 4 treatment sessions each of 4 nonpharmacological treatments: (1) hypnotic cognitive therapy (using hypnosis to alter the meaning of pain); (2) standard cognitive therapy; (3) hypnosis focused on pain reduction, and (4) pain education. One hundred seventy-three individuals with chronic pain were randomly assigned to receive 4 sessions of 1 of the 4 treatments. Primary (pain intensity) and secondary outcome measures were administered by assessors unaware of treatment allocation at pretreatment, posttreatment, and 3-, 6-, and 12-month follow-up. Treatment effects were evaluated using analysis of variance, a generalized estimating equation approach, or a Fisher exact test, depending on the outcome domain examined. All 4 treatments were associated with medium to large effect size improvements in pain intensity that maintained up to 12 months posttreatment. Pretreatment to posttreatment improvements were observed across the 4 treatment conditions on the secondary outcomes of pain interference and depressive symptoms, with some return towards pretreatment levels at 12-month follow-up. No significant between-group differences emerged in omnibus analyses, and few statistically significant between-group differences emerged in the planned pairwise analyses, although the 2 significant effects that did emerge favored hypnotic cognitive therapy. Future research is needed to determine whether the significant differences that emerged are reliable.

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.

Quadriceps femoris performance after resistance training with and without photobiomodulation in elderly women: a randomized clinical trial.

The study assessed if quadriceps femoris muscle performance of older women can be improved by applying photobiomodulation therapy after a resistance training program. This study is a randomized, controlled trial with concealed allocation, intention-to-treat analysis, and blinded outcome evaluators. Forty-five healthy sedentary older women classified as active or insufficiently active were randomized to groups receiving 8 weeks of quadriceps femoris resistance training plus active group or placebo group, or a control group (no training or photobiomodulation). Surface electromyographic fatigue indexes of vastus medialis, rectus femoris, and vastus lateralis; one-maximum repetition (1-MR); and analysis of inflammatory biomarkers (IL-6, IL-8, and TNF-α cytokines, plus CK and LDH enzymes) were measured at baseline and twice in a 24 h-period after 8 weeks. No differences among the three groups were found in fatigue indexes for all three muscles, although in general, the active group presented improved fatigue indexes from baseline to 8-week outcome, while the other groups did not. Both training groups improved in 1-MR over the 8-week period. Inflammatory biomarkers were not different at long- or short-term among the three groups, except differences in groups for long-term IL-8 changes, differences in time for long-term LDH and short-term TNF-α changes, and interactions of time by group for short-term LDH changes. Quadriceps femoris performance of older women was not improved when photobiomodulation was associated to the proposed quadriceps femoris resistance training, when compared to training without photobiomodulation and a sedentary group.

Effects of Light-Emitting Diode Therapy on the Performance of Biceps Brachii Muscle of Young Healthy Males After 8 Weeks of Strength Training: A Randomized Controlled Clinical Trial.

Vieira, KVSG, Ciol, MA, Azevedo, PH, Pinfildi, CE, Renno, ACM, Colantonio, E, and Tucci, HT. Effects of light-emitting diode therapy on the performance of biceps brachii muscle of young healthy males after 8 weeks of strength training: a randomized controlled clinical trial. J Strength Cond Res 33(2): 433-442, 2019-We assessed the effect of adding light-emitting diode therapy (LEDT) to an 8-week strength training of biceps brachii in healthy young males. Forty-five participants were randomized into training plus LEDT, training plus sham LEDT, and control groups (n = 15 each). Individuals in the LEDT groups participated in strength training performed in a Scott machine at their maximum number of elbow flexion-extension repetitions. The LEDT was applied to biceps brachii of dominant limb at the end of training sessions (device "on" for LEDT and "off" for sham LEDT). Training loads were re-evaluated every 2 weeks. Controls did not receive training during 8 weeks. All groups were evaluated for 1 repetition maximum (1RM) and fatigue at baseline and 8 weeks. Additionally, the 2 LEDT groups were evaluated every 2 weeks for 1-RM and number of elbow flexion-extension repetitions. The groups were statistically different in mean difference and mean percent change of 1-RM from baseline to week 8 (p < 0.001). Analyzing the 2 LEDT groups, we found an interaction between group and time (p = 0.02), with a slightly faster increase in 1-RM for the LEDT than the sham LEDT. Over time, both groups decreased the number of repetitions of elbow flexion-extension (differences not statistically significant), possibly because of the increase of load over time. We found no difference in change of fatigue index among the 3 groups. Our study showed potential benefits to 1RM when LEDT is applied after a strength training session. Future studies might assess whether different doses of LEDT can reduce fatigue in strength training.

A longitudinal analysis of total 3-year healthcare costs for older adults who experience a fall requiring medical care.

OBJECTIVES: To compare longitudinal changes in healthcare costs between fallers admitted to the hospital at the time of the fall (admitted), those not admitted to the hospital (nonadmitted), and nonfaller controls; test hypotheses related to differences in mean costs between and within these groups over time; and estimate the costs attributable to falling. DESIGN: Longitudinal cohort. SETTING: Group Health Cooperative of Puget Sound. PARTICIPANTS: Seven thousand nine hundred ninety-three nonadmitted fallers, 976 admitted fallers, and 8,956 nonfallers aged 67 and older enrolled in an integrated healthcare delivery system. Fallers were identified according to fall-related E-Codes and International Classification of Diseases, Ninth Revision codes recorded between January 1, 2004, and December 31, 2006. Nonfallers were frequency matched on age group and sex. MEASUREMENTS: Quarterly costs during a 3-year period were modeled using generalized estimating equations. Covariates included index age, sex, RxRisk (a comorbidity adjuster), fall status, time, and interactions between fall status and time. RESULTS: Cost differences between the faller cohorts and nonfallers were greatest in quarters closest to the fall (all P<.01) and persisted throughout the entire year of follow-up. Although nonfaller costs increased with time, faller cohort costs increased more quickly (all P<.01). For admitted fallers, 92% of costs incurred in the quarter of the fall were estimated to be attributable to falling ($27,745 of $30,038, P<.001). CONCLUSION: Falls for which medical attention are sought resulted in higher costs than for nonfallers for up to 12 months after a fall, particularly for falls requiring hospitalization. Prevention efforts should focus on reducing fall-related injuries requiring hospitalization because they produce the highest excess costs and have a higher likelihood of 1-year mortality.

Disparities in outpatient and home health service utilization following stroke: results of a 9-year cohort study in Northern California.

OBJECTIVE: To examine whether there are disparities in utilization of outpatient and home care services after stroke. DESIGN: Retrospective cohort study. SETTING: The Kaiser Permanente of Northern California health care system, which provides health care for approximately 3.3 million members. PARTICIPANTS: A total of 11,119 patients hospitalized for a stroke between 1996 and 2003 and followed for 1 year. MAIN OUTCOME MEASURES: Receipt of outpatient rehabilitation (physical therapy, occupational therapy, speech pathology, or physical medicine and rehabilitation/physiatry visits), and/or home health care. RESULTS: There were significant differences in outpatient rehabilitation visits and home health enrollment during the year after acute care discharge for all the parameters under study. Older age and female gender were associated with less outpatient rehabilitation treatment, but these subpopulations were more likely to be enrolled in home health care. Non-whites, patients from urban areas, those with ischemic strokes, and those with longer acute care hospital stays had relatively more outpatient rehabilitation and were also more likely to be enrolled in the home health program. In addition, patients living in geographic areas with a median household income of $80,000 or more had significantly more outpatient rehabilitation visits than did patients living in lower income areas. CONCLUSIONS: Variations in outpatient rehabilitation visits and in home health care exist in this large integrated health system in terms of age, gender, race/ethnicity, residence area, type of stroke, and length of stay in an acute care hospital. The Kaiser Permanente integrated health care system seems to have outpatient stroke rehabilitation and home health programs that are providing care without disparities in relation to non-white populations, but other disparities appear to exist that may be related to socioeconomic factors, referral patterns, family support systems, or other cultural factors that have not been identified.

Disparities in stroke rehabilitation: results of a study in an integrated health system in northern California.

OBJECTIVE: To determine whether there are disparities in postacute stroke rehabilitation based on type of stroke, race/ethnicity, sex/gender, age, socioeconomic status, geographic region, or service area referral patterns in a large integrated health system with multiple levels of care. DESIGN: Cohort study tracking rehabilitation services for 365 days after acute hospitalization for a first stroke. SETTING: The Northern California Kaiser Permanente Health System (approximately 3.3 million membership population) PARTICIPANTS: A total of 11,119 patients hospitalized for acute stroke from 1996 to 2003. The cohort includes patients discharged from acute care after a stroke. Postacute care rehabilitation services were evaluated according to the level of care ever-received within the 365 days after discharge from acute care, including inpatient rehabilitation hospital (IRH), skilled nursing facility (SNF), home health and outpatient, or no rehabilitation services. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Service delivery. RESULTS: Patients discharged to an IRH had longer lengths of stay in acute care. Patients with hemorrhagic stroke were less likely to be treated in an IRH. Patients whose highest level of rehabilitation was SNF were older and more likely to be women. After adjusting for age and other covariates, women were less likely to go to an IRH than men. Asian and black patients were more likely than white patients to be treated in an IRH or SNF. Also more likely to go to an IRH were patients from higher socioeconomic groups, from urban areas, and from geographic areas close to the regional rehabilitation hospital. CONCLUSIONS: These results suggest variation in care delivery and extent of postacute care based on differences in patient demographics and geographic factors. Results also varied over time. Some minority populations in this cohort appeared to be more likely to receive IRH care, possibly because of disease severity, family support systems, cultural factors, or differences in referral patterns.