Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial.
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SUBMITTER: Huberty JL
PROVIDER: S-EPMC7790277 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
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Testing a mindfulness meditation mobile app for the treatment of sleep-related symptoms in adults with sleep disturbance: A randomized controlled trial.
Huberty Jennifer L JL Green Jeni J Puzia Megan E ME Larkey Linda L Laird Breanne B Vranceanu Ana-Maria AM Vlisides-Henry Robert R Irwin Michael R MR
PloS one 20210107 1
The objective of this randomized controlled trial was to test whether a commercially available, mindfulness meditation mobile app, (i.e., Calm app), was effective in reducing fatigue (primary outcome), pre-sleep arousal, and daytime sleepiness (secondary outcomes) in adults with sleep disturbance (Insomnia Severity Index Score >10) as compared to a wait-list control group. Associations between the use of the Calm app (i.e., adherence to the intervention) and changes in sleep quality was also exp ...[more]
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Project description:BackgroundCollege students experience high levels of stress. Mindfulness meditation delivered via a mobile app may be an appealing, efficacious way to reduce stress in college students.ObjectiveWe aimed to test the initial efficacy and sustained effects of an 8-week mindfulness meditation mobile app-Calm-compared to a wait-list control on stress, mindfulness, and self-compassion in college students with elevated stress. We also explored the intervention's effect on health behaviors (ie, sleep disturbance, alcohol consumption [binge drinking], physical activity, and healthy eating [fruit and vegetable consumption]) and the feasibility and acceptability of the app.MethodsThis study was a randomized, wait-list, control trial with assessments at baseline, postintervention (8 weeks), and at follow-up (12 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored ≥14 points on the Perceived Stress Scale, (3) owned a smartphone, (4) were willing to download the Calm app, (5) were willing to be randomized, and (7) were able to read and understand English. Participants were asked to meditate using Calm at least 10 minutes per day. A P value ≤.05 was considered statistically significant.ResultsA total of 88 participants were included in the analysis. The mean age (SD) was 20.41 (2.31) years for the intervention group and 21.85 (6.3) years for the control group. There were significant differences in all outcomes (stress, mindfulness, and self-compassion) between the intervention and control groups after adjustment for covariates postintervention (all P<.04). These effects persisted at follow-up (all P<.03), except for the nonreacting subscale of mindfulness (P=.08). There was a significant interaction between group and time factors in perceived stress (P=.002), mindfulness (P<.001), and self-compassion (P<.001). Bonferroni posthoc tests showed significant within-group mean differences for perceived stress in the intervention group (P<.001), while there were no significant within-group mean differences in the control group (all P>.19). Similar results were found for mindfulness and self-compassion. Effect sizes ranged from moderate (0.59) to large (1.24) across all outcomes. A significant group×time interaction in models of sleep disturbance was found, but no significant effects were found for other health behaviors. The majority of students in the intervention group reported that Calm was helpful to reduce stress and stated they would use Calm in the future. The majority were satisfied using Calm and likely to recommend it to other college students. The intervention group participated in meditation for an average of 38 minutes/week during the intervention and 20 minutes/week during follow-up.ConclusionsCalm is an effective modality to deliver mindfulness meditation in order to reduce stress and improve mindfulness and self-compassion in stressed college students. Our findings provide important information that can be applied to the design of future studies or mental health resources in university programs.Trial registrationClinicalTrials.gov NCT03891810; https://clinicaltrials.gov/ct2/show/NCT03891810.
| S-EPMC6614998 | biostudies-literature
Project description:BackgroundMental health and sleep problems are prevalent in the workforce, corresponding to costly impairment in productivity and increased health care use. Digital mindfulness interventions are efficacious in improving sleep and mental health in the workplace; however, evidence supporting their pragmatic utility, potential for improving productivity, and ability to reduce employer costs is limited.ObjectiveThis pragmatic, cluster randomized controlled trial aimed to evaluate the experimental effects of implementing a commercially available mindfulness app-Calm-in employees of a large, multisite employer in the United States. Outcomes included mental health (depression, anxiety, and stress), sleep (insomnia and daytime sleepiness), resilience, productivity impairment (absenteeism, presenteeism, overall work impairment, and non-work activity impairment), and health care use (medical visit frequency).MethodsEmployees were randomized at the work site to receive either the Calm app intervention or waitlist control. Participants in the Calm intervention group were instructed to use the Calm app for 10 minutes per day for 8 weeks; individuals with elevated baseline insomnia symptoms could opt-in to 6 weeks of sleep coaching. All outcomes were assessed every 2 weeks, with the exception of medical visits (weeks 4 and 8 only). Effects of the Calm intervention on outcomes were evaluated via mixed effects modeling, controlling for relevant baseline characteristics, with fixed effects of the intervention on outcomes assessed at weeks 2, 4, 6, and 8. Models were analyzed via complete-case and intent-to-treat analyses.ResultsA total of 1029 employees enrolled (n=585 in the Calm intervention group, including 101 who opted-in to sleep coaching, and n=444 in waitlist control). Of them, 192 (n=88 for the Calm intervention group and n=104 for waitlist) completed all 5 assessments. In the complete-case analysis at week 8, employees at sites randomized to the Calm intervention group experienced significant improvements in depression (P=.02), anxiety (P=.01), stress (P<.001), insomnia (P<.001), sleepiness (P<.001), resilience (P=.02), presenteeism (P=.01), overall work impairment (P=.004), and nonwork impairment (P<.001), and reduced medical care visit frequency (P<.001) and productivity impairment costs (P=.01), relative to the waitlist control. In the intent-to-treat analysis at week 8, significant benefits of the intervention were observed for depression (P=.046), anxiety (P=.01), insomnia (P<.001), sleepiness (P<.001), nonwork impairment (P=.04), and medical visit frequency (P<.001).ConclusionsThe results suggest that the Calm app is an effective workplace intervention for improving mental health, sleep, resilience, and productivity and for reducing medical visits and costs owing to work impairment. Future studies should identify optimal implementation strategies that maximize employee uptake and large-scale implementation success across diverse, geographically dispersed employers.Trial registrationClinicalTrials.gov NCT05120310; https://clinicaltrials.gov/ct2/show/NCT05120310.
| S-EPMC9557765 | biostudies-literature
Project description:ObjectivesTo assess the benefits of training in mindfulness-based stress reduction (MBSR) or moderate intensity exercise (EX) for improving sleep quality.DesignRandomized controlled trial.SettingOutpatient, community-based.ParticipantsHealthy adults (n = 413) aged 30-69 who did not regularly exercise or practice meditation, and who had no known prior sleep problems.Interventions1) 8-weeks of MBSR training; 2) matched EX training; or 3) wait-list control.MeasurementsThe Pittsburgh Sleep Quality Index (PSQI) was administered at baseline and at 1, 3, 5, and 7-month follow-up visits.AnalysisTotal PSQI scores and three PSQI factors (perceived sleep quality; daily disturbance, sleep efficiency) were assessed using linear mixed effects regression models for longitudinal data.ResultsCompared to controls, PSQI global scores improved significantly for EX (mean change -0.98 points [95% CI -1.56, -0.41] p = 0.001) and marginally for MBSR (-0.53 [-1.10, 0.04] p = 0.07). The perceived sleep quality factor improved for both EX (-0.18 [-0.30, -0.07] p = 0.002) and MBSR (-0.12 [-0.24, -0.01] p = 0.035). The daily disturbance factor improved slightly more for MBSR (-0.13 [-0.22, -0.033] p = 0.008) than EX (-0.09 [-0.19, 0.004] p = 0.06). The sleep efficiency factor did not improve after MBSR (0.08 [-0.045, 0.21] p = 0.2) or EX (-0.07 [-0.20, 0.06] p = 0.3). Improvements in the sleep quality were sustained over 7 months for both groups.ConclusionsTraining in MBSR and EX produced small but statistically significant and sustained improvements in sleep quality. For EX participants, this improvement was due primarily to improvements in perceived sleep quality. For MBSR, the decrease in daily disturbance was more important.
| S-EPMC8157793 | biostudies-literature
Project description:ObjectiveLatino immigrants experience acculturative stress and increased depression risk. Mindfulness meditation improves depressive symptoms, yet the vast majority of research has focused on English speaking populations.MethodsIn this randomized clinical trial with 2 parallel treatment groups, adults with moderate levels of perceived stress (n = 76) were recruited from the Los Angeles community from October 2015 to March 2016, stratified into Spanish- (n = 36) and English speaking (n = 40) language groups, and randomized for 6 weeks of treatment with standardized mindful awareness practices (MAPs) or health education (HE). Main outcome measure was depressive symptoms, measured by the Beck Depression Inventory.ResultsUsing an intent-to-treat analysis, the primary outcome, depressive symptoms as indexed by the Beck Depression Inventory, showed greater improvement in MAPs vs. HE, with a between-group post-intervention mean difference of -2.2 (95% CI -4.4 - -0.07) and effect size of 0.28; similar effect sizes were found in the the Spanish- (0.29) and English speaking (0.30) groups. MAPs showed significant improvement relative to HE on secondary outcome of mindfulness with between group difference of 10.7 (95% CI4.5-16.9), but not perceived stress.ConclusionThe comparable efficacy of Spanish and English formats of mindfulness meditation in improving depressive symptoms suggests that this community based intervention may mitigate depression risk in Latino adults who are experiencing social adversity.Trial registrationClinicalTrials.gov NCT03545074.
| S-EPMC6611613 | biostudies-literature
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:BackgroundTo address the unmet need for a commercial cancer-specific meditation app, we leveraged a long-standing partnership with a consumer-based app (ie, Calm) to develop the first commercial meditation app prototype adapted specifically for the needs of patients with cancer. Input was obtained at both the individual user and clinic levels (ie, patients with and survivors of cancer and health care providers).ObjectiveThis study aimed to determine the feasibility of a cancer-specific meditation app prototype.MethodsPatients with and survivors of cancer who were recruited and enrolled in the feasibility randomized controlled trial were asked to use the prototype app daily (≥70 minutes per week) for 4 weeks. Participants completed web-based weekly questionnaires and a final poststudy questionnaire and were asked to participate in an optional web-based poststudy interview. The questionnaires and interviews covered the following feasibility categories: acceptability, demand, practicality, and adaptation.ResultsA total of 36 patients with and survivors of cancer completed the baseline questionnaire, 18 completed the final questionnaire, and 6 completed the optional interviews. Weekly and poststudy questionnaires indicated high overall enjoyment, ease of use, and satisfaction with the app content, aesthetics, and graphics. The objective use data indicated that the average total app use rate was 73.39 (SD 7.12) minutes per week. Interviews (N=6) revealed positive and mixed responses to the app prototype and informative differences related to preferences for narrators, emotional content, and meditation teaching but an overall appreciation for the variety of options.ConclusionsThe most likely candidates for moving from cancer-specific meditation apps to dissemination are through partnering with the industry, in which name recognition and market distribution are already established (even showing a base of users from the targeted population with cancer). This study established the feasibility of a cancer-specific mobile meditation app prototype for patients with and survivors of cancer, using a commercially available app. The quantitative and qualitative data demonstrated the acceptability, demand, practicality, and adaptation of the prototype. Improvements suggested by the participants will be considered in the final app design before testing the efficacy of the app in a future study.Trial registrationClinicaltrials.gov NCT05459168; https://clinicaltrials.gov/ct2/show/record/NCT05459168.
| S-EPMC9730204 | biostudies-literature
Project description:BackgroundPhysical and mental health benefits can be attained from persistent, long-term performance of mindfulness meditation with a mobile meditation app, but in general, few mobile health app users persistently engage at a level necessary to attain the corresponding health benefits. Anchoring or pairing meditation with a mobile app to an existing daily routine can establish an unconsciously initiated meditation routine that may improve meditation persistence.ObjectiveThe purpose of this study was to test the use of either personalized anchors or fixed anchors for establishing a persistent meditation app routine with the mobile app, Calm.MethodsWe conducted a randomized controlled trial and randomly assigned participants to one of 3 study groups: (1) a personalized anchor (PA) group, (2) fixed anchor (FA) group, or (3) control group that did not use the anchoring strategy. All participants received app-delivered reminder messages to meditate for at least 10 minutes a day using the Calm app for an 8-week intervention period, and app usage data continued to be collected for an additional 8-week follow-up period to measure meditation persistence. Baseline, week 8, and week 16 surveys were administered to assess demographics, socioeconomic status, and changes in self-reported habit strength.ResultsA total of 101 participants across the 3 study groups were included in the final analysis: (1) PA (n=56), (2) FA (n=49), and (3) control group (n=62). Participants were predominantly White (83/101, 82.2%), female (77/101, 76.2%), and college educated (ie, bachelor's or graduate degree; 82/101, 81.2%). The FA group had a significantly higher average odds of daily meditation during the intervention (1.14 odds ratio [OR]; 95% CI 1.02-1.33; P=.04), and all participants experienced a linear decline in their odds of daily meditation during the 8-week intervention (0.96 OR; 95% CI 0.95-0.96; P<.001). Importantly, the FA group showed a significantly smaller decline in the linear trend of their odds of daily meditation during the 8-week follow-up (their daily trend increased by 1.04 OR from their trend during the intervention; 95% CI 1.01-1.06; P=.03). Additionally, those who more frequently adhered to their anchoring strategy during the intervention typically used anchors that occurred in the morning and showed a significantly smaller decline in their odds of daily meditation during the 8-week follow-up period (1.13 OR; 95% CI 1.02-1.35; P=.007).ConclusionsThe FA group had more persistent meditation with the app, but participants in the FA or PA groups who more frequently adhered to their anchoring strategy during the intervention had the most persistent meditation routines, and almost all of these high anchorers used morning anchors. These findings suggest that the anchoring strategy can create persistent meditation routines with a mobile app. However, future studies should combine anchoring with additional intervention tools (eg, incentives) to help more participants successfully establish an anchored meditation routine.Trial registrationClinicalTrials.gov NCT04378530; https://clinicaltrials.gov/ct2/show/NCT04378530.
| S-EPMC8734923 | biostudies-literature
Project description:ImportanceSleep disturbances are most prevalent among older adults and often go untreated. Treatment options for sleep disturbances remain limited, and there is a need for community-accessible programs that can improve sleep.ObjectiveTo determine the efficacy of a mind-body medicine intervention, called mindfulness meditation, to promote sleep quality in older adults with moderate sleep disturbances.Design, setting, and participantsRandomized clinical trial with 2 parallel groups conducted from January 1 to December 31, 2012, at a medical research center among an older adult sample (mean [SD] age, 66.3 [7.4] years) with moderate sleep disturbances (Pittsburgh Sleep Quality Index [PSQI] >5).InterventionsA standardized mindful awareness practices (MAPs) intervention (n = 24) or a sleep hygiene education (SHE) intervention (n = 25) was randomized to participants, who received a 6-week intervention (2 hours per week) with assigned homework.Main outcomes and measuresThe study was powered to detect between-group differences in moderate sleep disturbance measured via the PSQI at postintervention. Secondary outcomes pertained to sleep-related daytime impairment and included validated measures of insomnia symptoms, depression, anxiety, stress, and fatigue, as well as inflammatory signaling via nuclear factor (NF)-κB.ResultsUsing an intent-to-treat analysis, participants in the MAPs group showed significant improvement relative to those in the SHE group on the PSQI. With the MAPs intervention, the mean (SD) PSQIs were 10.2 (1.7) at baseline and 7.4 (1.9) at postintervention. With the SHE intervention, the mean (SD) PSQIs were 10.2 (1.8) at baseline and 9.1 (2.0) at postintervention. The between-group mean difference was 1.8 (95% CI, 0.6-2.9), with an effect size of 0.89. The MAPs group showed significant improvement relative to the SHE group on secondary health outcomes of insomnia symptoms, depression symptoms, fatigue interference, and fatigue severity (P < .05 for all). Between-group differences were not observed for anxiety, stress, or NF-κB, although NF-κB concentrations significantly declined over time in both groups (P < .05).Conclusions and relevanceThe use of a community-accessible MAPs intervention resulted in improvements in sleep quality at immediate postintervention, which was superior to a highly structured SHE intervention. Formalized mindfulness-based interventions have clinical importance by possibly serving to remediate sleep problems among older adults in the short term, and this effect appears to carry over into reducing sleep-related daytime impairment that has implications for quality of life.Trial registrationclinicaltrials.gov Identifier: NCT01534338.
| S-EPMC4407465 | biostudies-literature
Project description:BackgroundMindfulness training (MT) includes a variety of contemplative practices aimed at promoting intentional awareness of experience, coupled with attitudes of nonjudgment and curiosity. Following the success of 8-week, manualized group interventions, MT has been implemented in a variety of modalities, including smartphone apps that seek to replicate the success of group interventions. However, although smartphone apps are scalable and accessible to a wider swath of population, their benefits remain largely untested.ObjectiveThis study aimed to investigate a newly developed MT app called Wildflowers, which was codeveloped with the laboratory for use in mindfulness research. It was hypothesized that 3 weeks of MT through this app would improve subjective well-being, attentional control, and interoceptive integration, albeit with weaker effects than those published in the 8 week, manualized group intervention literature.MethodsUndergraduate students completed 3 weeks of MT with Wildflowers (n=45) or 3 weeks of cognitive training with a game called 2048 (n=41). State training effects were assessed through pre- and postsession ratings of current mood, stress level, and heart rate. Trait training effects were assessed through pre- and postintervention questionnaires canvassing subjective well-being and behavioral task measures of attentional control and interoceptive integration. State and trait training data were analyzed in a multilevel model using emergent latent factors (acceptance, awareness, and openness) to summarize the trait questionnaire battery.ResultsAnalyses revealed both state and trait effects specific to MT; participants engaging in MT demonstrated improved mood (r=.14) and a reduction of stress (r=-.13) immediately after each training session compared with before the training session and decreased postsession stress over 3 weeks (r=-.08). In addition, MT relative to cognitive training resulted in greater improvements in attentional control (r=-.24). Interestingly, both groups demonstrated increased subjective ratings of awareness (r=.28) and acceptance (r=.23) from pre- to postintervention, with greater changes in acceptance for the MT group trending (r=.21).ConclusionsMT, using a smartphone app, may provide immediate effects on mood and stress while also providing long-term benefits for attentional control. Although further investigation is warranted, there is evidence that with continued usage, MT via a smartphone app may provide long-term benefits in changing how one relates to their inner and outer experiences.Trial registrationClinicalTrials.gov NCT03783793; https://clinicaltrials.gov/ct2/show/NCT03783793 (Archived by WebCite at http://www.webcitation.org/75EF2ehst).
| S-EPMC6329416 | biostudies-literature
Project description:ObjectivesAmidst the COVID-19 pandemic, healthcare workers (HCWs) may be at greater risk of suffering from psychological distress compared to the general population. This study aimed to investigate the effects of mindfulness practice as delivered using Headspace on psychological and cognitive outcomes among HCWs in Singapore.MethodsA total of 80 HCWs were recruited and randomly assigned to engage in either 3 weeks (10 min/day) of mindfulness practice using Headspace or an active control condition (Lumosity; involving playing cognitive games). Participants were administered several self-report measures and two working memory (digit span) tasks at pre- and post-intervention, and one-month follow-up.ResultsThere were no significant between-condition changes on any outcome variables from pre- to post-intervention. From pre-intervention to 1-month follow-up, there were significantly greater improvements among Headspace participants on fear of COVID-19 (p = .005), compassion satisfaction (p = .007), trait mindfulness (p = .002), self-compassion (p = .005), sleep quality (p = .002), and the forward digit span task (p < .001). Several outcomes were mediated by increases in trait mindfulness or self-compassion.ConclusionsUse of Headspace may lead to downstream benefits in reducing distress and improving psychological health outcomes among HCWs. The findings have implications for improving psychological support resources for HCWs amidst a pandemic.Trial registrationClinicalTrials.gov (Identifier: NCT04936893).
| S-EPMC9483434 | biostudies-literature