Randomized, wait-list–controlled pilot study of app-delivered mindfulness for patients reporting chronic pain
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SUBMITTER: Mascaro J
PROVIDER: S-EPMC8546841 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundHealth care provider and trainee burnout results in substantial national and institutional costs and profound social effects. Identifying effective solutions and interventions to cultivate resilience among health care trainees is critical. Although less is known about the mental health needs of physician assistants (PAs) or PA students, accumulating research indicates that they experience similarly alarming rates of burnout, depression, and emotional exhaustion. Mobile app-delivered mindfulness meditation may be an effective part of salubrious programming to bolster long-term resilience and health among PA students.ObjectiveThis study aims to examine the impact of app-delivered mindfulness meditation on self-reported mental health symptoms among PA students. A secondary aim is to investigate changes in brain connectivity to identify neurobiological changes related to changes in mental health symptoms.MethodsWe recruited PA students enrolled in their third semester of PA school and used a longitudinal, randomized, wait-list-controlled design. Participants randomized to the mindfulness group were provided 1-year subscriptions to the 10% Happier app, a consumer-based meditation app, and asked to practice every day for 8 weeks. Before randomization and again after completion of the 8-week program, all participants completed resting-state functional magnetic resonance imaging as well as self-report assessments of burnout, depression, anxiety, and sleep impairment. App use was acquired as a measure of mindfulness practice time.ResultsPA students randomized to the mindfulness group reported improvements in sleep impairment compared with those randomized to the wait-list control group (ηp2=0.42; P=.01). Sleep impairment decreased significantly in the mindfulness group (19% reduction; P=.006) but not in the control group (1% reduction; P=.71). There were no other significant changes in mental health for those randomized to app-delivered mindfulness. Across all students, changes in sleep impairment were associated with increased resting-state functional connectivity between the medial prefrontal cortex (a component of the default mode network) and the superior temporal gyrus, as well as between areas important for working memory. Changes in connectivity predicted categorical conversion from impaired to nonimpaired sleep in the mindfulness group.ConclusionsThis pilot study is the first to examine app-based mindfulness for PA students' mental health and investigate the impact of mindfulness on PA students' brain function. These findings suggest that app-delivered mindfulness may be an effective tool to improve sleep dysfunction and that it may be an important part of the programming necessary to reduce the epidemic of suffering among health profession trainees.
| S-EPMC8564666 | biostudies-literature
Project description:BackgroundShoulder pain is an uncomfortable feeling in the muscle around the shoulder. The cause of myalgia is the accumulation of lactic acid in muscles and impaired blood circulation, which is called blood stasis in traditional East Asian medicine. This study aimed to explore the therapeutic effect of Gyejibongnyeong-Hwan (GBH) for shoulder discomfort related to blood stasis before and after treatment.Methods/designThis study will be a double-centre, randomised, wait-list controlled pilot trial. Participants with shoulder pain and with a visual analogue scale score of 4 or higher out of 10, blood stasis score of 9 or higher, and triglyceride level of ≥150 mg/dl or total cholesterol level of ≥200 mg/dl will be recruited from two university hospitals. A total of 40 participants will be assigned to the immediate and waiting treatment groups. The immediate treatment group will receive GBH for 8 weeks on enrolment while the waiting treatment group will receive GBH for 8-16 weeks after 8 weeks of controlled waiting. The primary outcome is shoulder pain, and the secondary outcomes are the blood stasis score, blood pressure, ankle-brachial pressure index, brachial-ankle pulse wave velocity, body mass index, waist circumference, indexes of oximetry, and levels of blood lipid, blood sugar, resistin, C-reactive protein, serum amyloid P, and D-dimer.DiscussionThe results of this pilot trial will be the bases for a full-scale clinical trial of GBH.Trial registrationClinical Research Information Service, KCT0003837. Registered on 23 April 2019. https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=14258.
| S-EPMC7027269 | biostudies-literature
Project description:BACKGROUND:Physician burnout is on the rise, yet little is known about its relationship to anxiety. Mindfulness-based stress reduction has demonstrated decreases in anxiety, yet physicians have reported reluctance to engage in it due to significant time commitments. OBJECTIVE:The aims of this study are to assess whether app-based mindfulness training can reduce anxiety in physicians and to explore if anxiety and burnout are correlated, thus leading to a reduction in both anxiety and burnout. METHODS:This was a nonrandomized pilot study comprised of 34 physicians who worked in a large US health care network and reported having anxiety. The intervention was an app-based mindfulness program. The main outcome measure was anxiety, measured by the Generalized Anxiety Disorder-7 (GAD-7). The secondary outcome measures assessed burnout: cynicism and emotional exhaustion items from the Maslach Burnout Inventory. RESULTS:GAD-7 scores decreased significantly at posttreatment (1 month after treatment initiation, 48% reduction, P<.001) and at the 3-month follow-up (57% reduction, P<.001). There was a significant correlation between anxiety and burnout (cynicism: r=.43; P=.01; emotional exhaustion: r=.71; P<.001). There was also a significant decrease in cynicism (50% reduction, P=.003 at posttreatment; 50% reduction, P=.009 at follow-up) and emotional exhaustion at both time points (20% reduction, P<.001 at posttreatment; 20% reduction, P=.003 at follow-up). CONCLUSIONS:This pilot study is the first to test an app-based mindfulness training program targeted at reducing anxiety with physicians and to demonstrate that in physicians, anxiety is correlated with burnout. These findings suggest that this may be an effective tool to reduce anxiety and burnout in physicians. TRIAL REGISTRATION:ClinicalTrials.gov NCT04137081; https://www.clinicaltrials.gov/ct2/show/NCT04137081.
| S-EPMC7160707 | biostudies-literature
Project description:Chronic tennis elbow (lateral epicondylosis) is a common disorder. Like other chronic soft-tissue pain conditions it is often difficult to treat successfully. The effects of exercise have been discussed, but no convincing evidence has been put forward so far, and a simple protocol for exercise is lacking.This study is a randomized, controlled, clinical trial of the effect of exercise versus expectation (wait-list) on pain, muscle strength, function, and quality of life in patients with long-standing lateral epicondylosis.Eighty-one subjects with tennis elbow lasting for more than 3 months were randomly allocated to an exercise group (n = 40) or a reference group (n = 41). The exercise group performed daily exercise, with weekly load increase, for 3 months. The reference group was wait-listed, but otherwise followed in the same way. Outcome measures were pain during maximum voluntary muscle contraction (Cozen's test) and pain during maximum muscle elongation with a load (modified Empty-can-test); muscle strength was measured with a Chatillon MSE 100 hand-held dynamometer, and the Disability of the Arm, Shoulder and Hand (DASH) and the Gothenburg Quality of Life questionnaires.The exercise group had greater and faster regression of pain, both during muscle contraction and muscle elongation, than the reference group (p = 0.0005 and p = 0.0016, respectively). There was a non-significant muscle strength difference between the groups, but no differences regarding DASH scores or quality of life measures.Exercise appears to be superior to expectation in reducing pain in chronic lateral epicondylosis.
| S-EPMC3207303 | biostudies-literature
Project description:This study examines the impact of mindfulness-based stress reduction (MBSR) vs. wait list (WL) on the self-reference effect involving negative adjectives in individuals with social anxiety disorder (SAD). Eighty-five participants with SAD were randomly assigned to 12 weeks of MBSR or WL and completed an incidental SRE task that assessed treatment-related negative self-representations. Self-related negative adjectives were worse remembered in MBSR than in WL, and other-related negative adjectives were better remembered in MBSR than in WL. No differences emerged between the levels of self- and other-related processing for adjectives in MBSR. Moreover, the MBSR-related decreases in the difference in recognition memory performance between self and other conditions, that is, the treatment-related equilibrium, could predict the MBSR-related decreases in social anxiety symptoms. The selfless functioning and self-other control that can provide reasonable interpretations for these findings were discussed.
| S-EPMC8149603 | biostudies-literature
Project description:OBJECTIVE:Chronic pain is a disabling illness, often comorbid with depression. We performed a randomized controlled pilot study on mindfulness-based cognitive therapy (MBCT) targeting depression in a chronic pain population. METHOD:Participants with chronic pain lasting ? 3 months; DSM-IV major depressive disorder (MDD), dysthymic disorder, or depressive disorder not otherwise specified; and a 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C??) score ? 6 were randomly assigned to MBCT (n = 26) or waitlist (n = 14). We adapted the original MBCT intervention for depression relapse prevention by modifying the psychoeducation and cognitive-behavioral therapy elements to an actively depressed chronic pain population. We analyzed an intent-to-treat (ITT) and a per-protocol sample; the per-protocol sample included participants in the MBCT group who completed at least 4 of 8 sessions. Changes in scores on the QIDS-C?? and 17-item Hamilton Depression Rating Sale (HDRS??) were the primary outcome measures. Pain, quality of life, and anxiety were secondary outcome measures. Data collection took place between January 2012 and July 2013. RESULTS:Nineteen participants (73%) completed the MBCT program. No significant adverse events were reported in either treatment group. ITT analysis (n = 40) revealed no significant differences. Repeated-measures analyses of variance for the per-protocol sample (n = 33) revealed a significant treatment × time interaction (F?,?? = 4.67, P = .039, ?²p = 0.13) for QIDS-C?? score, driven by a significant decrease in the MBCT group (t?? = 5.15, P < .001, d = >1.6), but not in the control group (t?? = 2.01, P = .066). The HDRS?? scores did not differ significantly between groups. The study ended before the projected sample size was obtained, which might have prevented effect detection in some outcome measures. CONCLUSIONS:MBCT shows potential as a treatment for depression in individuals with chronic pain, but larger controlled trials are needed. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01473615.
| S-EPMC6020018 | biostudies-literature
Project description:BackgroundCardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined.ObjectiveThe aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery.MethodsA double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ≥18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ≥4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board.ResultsRecruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic.ConclusionsThis research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain.International registered report identifier (irrid)DERR1-10.2196/30951.
| S-EPMC8438614 | biostudies-literature
Project description:Opioid-treated chronic low back pain (CLBP) is debilitating, costly, and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP.Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone.Outpatient.Thirty-five adults with opioid-treated CLBP (?30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew.Eight weekly therapist-led MM sessions and at-home practice.Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct + indirect costs) were calculated for 6-month pre-enrollment and postenrollment periods and compared within and between the groups.Participants (21 MM; 14 control) were 20 percent men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/d, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat stimuli (p < 0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted.Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up.
| S-EPMC5836724 | biostudies-literature
Project description:The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators.This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety.Clinically stable outpatients were randomized to a mindfulness intervention (eight weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness, and multivariate linear regression to estimate the intervention effect on pre-post-intervention changes in these variables.We enrolled 45 patients (23 mindfulness and 22 control; age, 43-83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = 0.04) and anxiety (beta =?-1.15; p = 0.059) improved in the mindfulness group.Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients.
| S-EPMC3758416 | biostudies-literature
Project description:Objectives:Previous research indicates that mindfulness meditation reduces anxiety and depression and enhances well-being. We examined the impact of app-delivered mindfulness meditation on resting state functional MRI (fMRI) connectivity among physician assistant (PA) students and surgery residents. Methods:PA students and residents were randomized to receive a popular meditation app or to wait-list control group. Before and after the 8-week meditation period, we acquired fMRI scans of participants' resting state, and participants completed a self-report measure of mindfulness. We used a 2?×?2, within- and between-group factorial design and leveraged a whole-brain connectome approach to examine changes in within- and between-network connectivity across the entire brain, and to examine whether changes in connectivity were associated with app use or to changes in self-reported mindfulness. Results:Meditation practitioners exhibited significantly stronger connectivity between the frontoparietal network and the left and right nucleus accumbens and between the default mode (DMN) and salience networks, among other regions. Mindfulness practice time was correlated with increased connectivity between the lateral parietal cortex and the supramarginal gyrus, which were also positively correlated with increased scores on the "Describing" subscale of the Five Facet Mindfulness Questionnaire between baseline and post-meditation. These findings are consistent with previous research indicating that mindfulness-based interventions alter functional connectivity within the DMN and between the DMN and other networks both during meditation and at rest, as well as increased connectivity in systems important for emotion and reward. Conclusions:Recent commentaries call for healthcare provider and trainee wellness programs that are sustainable and preventive in nature rather than reactive; these data indicate that even brief sessions of app-delivered mindfulness practice are associated with functional connectivity changes in a dose-dependent manner.
| S-EPMC7543678 | biostudies-literature