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Mindfulness meditation training to reduce symptom distress in transplant patients: rationale, design, and experience with a recycled waitlist.

ABSTRACT: Solid organ transplant recipients must take immune suppressive medications that have side effects, cause complications, and lead to distressing symptoms that reduce health-related quality of life (QOL). Mindfulness meditation has been shown to reduce these symptoms in other patient populations, and it is unlikely to interfere with the immune suppressive medication regimen.This article describes the design and rationale of a clinical trial to determine whether training in mindfulness meditation can reduce depression, anxiety and insomnia after transplantation, and summarizes baseline characteristics of the participants.Transplant recipients were randomized in equal numbers to one of three arms: a Mindfulness-based Stress Reduction (MBSR) program consisting of 8 weeks of group instruction, home practice and telephone monitoring; a time and attention control Health Education program; or a waitlist arm. After serving 6 months as waitlist controls, these participants were re-randomized to MBSR or Health Education. Evaluations were obtained at baseline (prior to the active interventions), 8 weeks, 6 months, and 1 year (after randomization to MBSR or Health Education only). The primary analysis will compare composite symptom scores between MBSR and Health Education, initially or after serving in the waitlist. Subsequent analyses will compare these two groups on depression, anxiety, and insomnia symptom scales and secondary outcomes of health-related QOL, actigraphy, and health care utilization. A separate analysis, using only data collected before re-randomization, will compare short-term outcomes between the waitlist and active treatment arms.One hundred fifty recipients were randomized and 72% of waitlist participants (31/43) were recycled to an active intervention after 6 months. Patient characteristics were balanced across trial arms after initial and secondary randomizations.Transplant recipients are a very select population. Their adherence to the intervention and willingness to serve as waitlist controls prior to re-randomization may be atypical. Participants were not blinded to treatment and primary outcomes are self-reports.The innovative design used in the trial enabled the waitlist group to directly contribute to the number in the primary analysis of active arms, and to also serve as an internal validation test. The trial may be a useful model for trials involving very small target populations.

SUBMITTER: Gross CR

PROVIDER: S-EPMC2818773 | biostudies-literature | 2009 Feb

REPOSITORIES: biostudies-literature

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Mindfulness meditation training to reduce symptom distress in transplant patients: rationale, design, and experience with a recycled waitlist.

Gross Cynthia R CR Kreitzer Mary Jo MJ Reilly-Spong Maryanne M Winbush Nicole Y NY Schomaker E Katherine EK Thomas William W

Clinical trials (London, England) 20090201 1

<h4>Background</h4>Solid organ transplant recipients must take immune suppressive medications that have side effects, cause complications, and lead to distressing symptoms that reduce health-related quality of life (QOL). Mindfulness meditation has been shown to reduce these symptoms in other patient populations, and it is unlikely to interfere with the immune suppressive medication regimen.<h4>Purpose</h4>This article describes the design and rationale of a clinical trial to determine whether t ...[more]

PMID: 19254938

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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.

Project description:Among the various strategies for modulating the components of the emotional responses, the cognitive reappraisal and distraction are highlighted in current researches. As indicated in recent studies, the capacity for emotional regulation can be improved by mindfulness meditation practicing. This practice usually offers benefits to people's cognitive functioning and aims to improve a characteristic that is intrinsic to every human being: the ability to turn attention to the present moment. Importantly, positive emotions might also be effective on emotional regulation and several meditation practices make use of it. Thus, we aimed to compare two meditation modalities: one focused on attention only (mindfulness) and another focused-on attention toward positive emotions [Twin Hearts Meditation (THM)]. Ninety healthy subjects without any previous experience in meditation were enrolled in this experiment. Of these participants, 30 were submitted to the mindfulness practice with full attention on the observation of thoughts; 30 to the THM; and 30 to a control group (no meditation practice). After one session of meditation, all the participants completed emotional regulation task judging the valence and arousal of pictures with emotional content. In addition to the behavioral data, the participants' psychophysiological measures were recorded via electrocardiography (ECG). The results demonstrate a greater efficacy of THM in suppressing the negative valence of the negative pictures and amplifying the valence of the positive ones. No effect of meditation was observed for the ECG. Our findings indicate that contemplative meditation (THM) can positively influence the emotion regulation ability, even when performed by non-meditators and only once. However, in mindfulness meditation this same immediate effect was not found. Our findings reveal that faster effects of meditation practices can be obtained by practices that considers either the attentional processing and the positive emotions.

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:BackgroundPeople 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.ObjectiveThis 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.MethodsParticipants (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.ResultsRecruitment 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.ConclusionsTo 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 registrationClinicalTrials.gov NCT05027113; https://clinicaltrials.gov/ct2/show/NCT05027113.International registered report identifier (irrid)DERR1-10.2196/35196.

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Mindfulness meditation training to reduce symptom distress in transplant patients: rationale, design, and experience with a recycled waitlist.

Publications

Mindfulness meditation training to reduce symptom distress in transplant patients: rationale, design, and experience with a recycled waitlist.

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