Dataset Information

App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

People of color (POC) who experience race-related stress are at risk of developing mental health problems, including high levels of stress, anxiety, and depression. Mindfulness meditation may be especially well suited to help POC cope, given its emphasis on gaining awareness and acceptance of emotions associated with discriminatory treatment. However, mindfulness meditation rarely reaches POC, and digital approaches could reduce this treatment gap by addressing traditional barriers to care.

Objective

This study will test the effectiveness of a self-directed app-based mindfulness meditation program among POC who experience elevated levels of race-related stress. Implementation outcomes such as treatment acceptability, adherence, and satisfaction will be examined.

Methods

Participants (n=80) will be recruited online by posting recruitment materials on social media and sending emails to relevant groups. In-person recruitment will consist of posting flyers in communities with significant POC representation. Eligible participants will be block randomized to either the intervention group (n=40) that will complete a self-directed 4-week mindfulness meditation program or a wait-list control condition (n=40) that will receive access to the app after study completion. All participants will complete measures at baseline, midtreatment, and posttreatment. Primary outcomes include changes in stress, anxiety, and depression, and secondary outcomes constitute changes in mindfulness, self-compassion, rumination, emotion suppression, and experiential avoidance. Exploratory analyses will examine whether changes in the secondary outcomes mediate changes in primary outcomes. Finally, treatment acceptability, adherence, and satisfaction will be examined descriptively.

Results

Recruitment began in October 2021. Data will be analyzed using multilevel modeling, a statistical methodology that accounts for the dependence among repeated observations. Considering attrition issues in self-directed digital interventions and their potential effects on statistical significance and treatment effect sizes, we will examine data using both intention-to-treat and per-protocol analyses.

Conclusions

To our knowledge, this will be the first study to provide data on the effectiveness of a self-directed app-based mindfulness meditation program for POC recruited based on elevated race-related stress, a high-risk population. Similarly, meaningful clinical targets for POC affected by stressors related to race will be examined. Findings will provide important information regarding whether this type of intervention is an acceptable treatment among these marginalized groups.

Trial registration

ClinicalTrials.gov NCT05027113; https://clinicaltrials.gov/ct2/show/NCT05027113.

International registered report identifier (irrid)

DERR1-10.2196/35196.

SUBMITTER: Ramos G

PROVIDER: S-EPMC9052031 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: Protocol for a Randomized Controlled Trial.

Ramos Giovanni G Aguilera Adrian A Montoya Amanda A Lau Anna A Wen Chu Yin CY Cruz Torres Victor V Chavira Denise D

JMIR research protocols 20220414 4

<h4>Background</h4>People of color (POC) who experience race-related stress are at risk of developing mental health problems, including high levels of stress, anxiety, and depression. Mindfulness meditation may be especially well suited to help POC cope, given its emphasis on gaining awareness and acceptance of emotions associated with discriminatory treatment. However, mindfulness meditation rarely reaches POC, and digital approaches could reduce this treatment gap by addressing traditional bar ...[more]

PMID: 35436228

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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).

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.

Project description:BACKGROUND:Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. OBJECTIVE:To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. METHODS:Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. RESULTS:Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. CONCLUSIONS:This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys).

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.

Project description:IntroductionInfertility and its treatment bring a considerable emotional burden. Increasing evidence demonstrates the effectiveness of smartphone-delivered mindfulness apps for reducing symptoms of emotional distress in both clinical and non-clinical populations. Evidence on this topic in women, men and couples experiencing infertility is currently under-represented. The aim of the MoMiFer study is, therefore, to investigate the efficacy of a stand-alone mobile mindfulness app on symptoms of emotional distress and fertility-related quality of life in people experiencing infertility.Methods and analysisThis study is an exploratory randomised controlled trial (RCT) with open enrollment. The primary outcomes are symptoms of emotional distress and fertility-related quality of life. Secondary outcomes are mindfulness skills, repetitive negative thinking, self-compassion, user-rated quality of the stand-alone mobile mindfulness app and use of the app. Experience sampling method and standardised self-report questionnaires are combined within a repeated measures design to measure the effects of the stand-alone mobile mindfulness app on the primary and secondary outcomes, apart from the use of the app. The latter will be evaluated through app tracking. People, including women, men and couples, experiencing infertility (n=60) will be randomised to an intervention group receiving the stand-alone mobile mindfulness app for 3 months or a wait-list control group. The app follows the format and content of Mindfulness-Based Stress Reduction. Data will be collected at baseline, at 1.5 months and 3 months after randomisation. Analysis will be according to intention to treat and based on general linear modelling and multilevel mixed-effects modelling.Ethics and disseminationThis study received approval from the Medical Ethical Committee of the Leuven University Hospital (Belgium). The findings of this exploratory RCT will be disseminated through presentations at public lectures, scientific institutions and meetings, and through peer-reviewed scientific articles.Trial registration numberNCT04143828.

Dataset Information

App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

App-Based Mindfulness Meditation for People of Color Who Experience Race-Related Stress: Protocol for a Randomized Controlled Trial.

Similar Datasets

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