Randomized, wait-list–controlled pilot study of app-delivered mindfulness for patients reporting chronic pain
Ontology highlight
ABSTRACT:
SUBMITTER: Mascaro J
PROVIDER: S-EPMC8546841 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
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:ImportanceVeterans often experience chronic insomnia, and professionals capable of delivering effective interventions to address this problem are lacking.ObjectiveTo evaluate the efficacy of the Restoring Effective Sleep Tranquility (REST) program, an occupational therapist-led cognitive-behavioral therapy for insomnia (CBT-I) intervention to treat sleep problems among post- 9/11 veterans.DesignWait-list controlled trial with 3-mo follow-up.SettingCommunity-based veteran support program in a Mountain West university.ParticipantsFifteen post-9/11 veterans with sleep disturbances who were assigned to either the REST intervention or a wait-list control group. Outcomes and Measures: Sleep-related, health-related, and participation-related patient-reported outcomes (PROs) and daily sleep diary variables.ResultsWait-list controlled trial benefits included improved sleep-related (e.g., sleep disturbance), health-related (e.g., depression), and participation-related (e.g., meaningful activity) PROs. Findings were confirmed after participants in both the intervention and the control groups (n = 13) received the REST intervention, including improved daily sleep diary outcomes (e.g., sleep efficiency). All gains were maintained at 3 mo.Conclusions and relevanceOccupational therapy practitioners with advanced training in CBT-I have the potential to safely deliver an effective CBT-I intervention to veterans with sleep disturbances in a community-based setting. What This Article Adds: Occupational therapy practitioners with sleep-related education and training can positively affect the well-being of their clients through improving sleep participation.
| S-EPMC9563081 | 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:BackgroundChronic 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.Aims of the studyThis 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.MethodsEighty-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.ResultsThe 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.ConclusionsExercise 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: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. 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-C₁₆) 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-C₁₆ and 17-item Hamilton Depression Rating Sale (HDRS₁₇) 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. 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 (F₁,₃₁ = 4.67, P = .039, η²p = 0.13) for QIDS-C₁₆ score, driven by a significant decrease in the MBCT group (t₁₈ = 5.15, P < .001, d = >1.6), but not in the control group (t₁₃ = 2.01, P = .066). The HDRS₁₇ 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. MBCT shows potential as a treatment for depression in individuals with chronic pain, but larger controlled trials are needed. 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:BackgroundContemplative trainings have been found to effectively improve social skills such as empathy and compassion. However, there is a lack of research on the efficacy of app-delivered mindfulness-based and dyadic practices in boosting socioaffective capacity.ObjectiveThe first aim of this study was to compare a novel app-delivered, partner-based socioemotional intervention (Affect Dyad) with mindfulness-based training to foster empathy and compassion for the self or others. The second aim of this study was to investigate the underlying mechanisms of these effects.MethodsThis randomized controlled trial included socioemotional and mindfulness-based interventions and a waitlist control group, which received socioemotional training after the postintervention assessment. We used linear mixed-effects models to test intervention effects on self-report measures and an ecologically valid computer task of empathy, compassion for the self and others, and theory of mind. Moderated mediation models were used to investigate whether changes in acceptance, empathic distress, empathic listening, interoceptive awareness, and mindfulness served as underlying psychological processes of intervention effects.ResultsIn 218 participants (mean age 44.12, SD 11.71 years; 160/218, 73.4% female), we found all interventions to have positive effects on composite scores for compassion toward the self (βsocioemotional=.44, P<.001; βwaitlist socioemotional=.30, P=.002; βmindfulness-based=.35, P<.001) and others (βsocioemotional=.24, P=.003; βwaitlist socioemotional=.35, P<.001; βmindfulness-based=.29, P<.001). Compassion measured with the computer task did not change significantly but showed a trend toward increase only in socioemotional dyadic practice (βsocioemotional=.08, P=.08; βwaitlist socioemotional=.11, P=.06). Similarly, on the empathic concern subscale of the Interpersonal Reactivity Index, a nonsignificant trend toward increase was found in the socioemotional intervention group (βsocioemotional=.17; P=.08). Empathy significantly increased in both socioemotional groups (βsocioemotional=.16, P=.03; βwaitlist socioemotional=.35, P<.001) and the mindfulness-based group (βmindfulness-based=.15; P=.04). The measures of theory of mind did not change over time. In the mindfulness-based group, the increase in self-compassion was mediated by a decrease in empathic distress (indirect effect abmindfulness-based=0.07, 95% CI 0.02-0.14). In the socioemotional group, an increase in self-compassion could be predicted by an increase in acceptance (βsocioemotional=6.63, 95% CI 0.52-12.38).ConclusionsUsing a multimethod approach, this study shows that app-delivered socioemotional and mindfulness-based trainings are effective in fostering compassion for the self and others in self-report. Both low-dose trainings could boost behavioral empathy markers; however, the effects on behavioral and dispositional markers of compassion only trended after dyadic practice, yet these effects did not reach statistical significance. Training-related increases in self-compassion rely on differential psychological processes, that is, on improved empathic distress regulation through mindfulness-based training and the activation of a human care- and acceptance-based system through socioemotional dyadic training.Trial registrationClinicalTrials.gov NCT04889508; https://clinicaltrials.gov/ct2/show/NCT04889508.
| S-EPMC10413229 | biostudies-literature
Project description:ObjectiveOpioid-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.DesignTwenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone.SettingOutpatient.ParticipantsThirty-five adults with opioid-treated CLBP (≥30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew.InterventionEight weekly therapist-led MM sessions and at-home practice.Outcome measuresCosts 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.ResultsParticipants (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.ConclusionsAdults 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