Project description:BackgroundParents of babies admitted to the Newborn Intensive Care Unit (NICU) undergo considerable stress. There is evidence that mindfulness reduces stress in these parents. Kangaroo Care (KC) is practiced in NICUs across the world and is stress-relieving. Whether mindfulness practiced during KC in the NICU reduces parental distress has not yet been studied. The objective was to explore the feasibility and acceptability of teaching and practicing mindfulness during KC for mothers of premature babies. The objective was also to document preliminary outcomes of Mindful Kangaroo Care (MKC) on maternal stress, anxiety, depression, and mindful awareness.MethodsIn this pilot randomized controlled study, mothers of premature babies who were expected to stay in the NICU for at least four weeks were taught two mindfulness exercises to practice during KC and compared to mothers who received standard care with no mindfulness teaching. Mothers filled out stress, anxiety, depression and mindful awareness scales at recruitment and after four weeks. Acceptability and feasibility questionnaires were also completed.ResultsFifteen mothers per group completed the study. The MKC group demonstrated a significant within-group reduction in anxiety (p = 0.003), depression (p = 0.02) and stress (p = 0.002), and a significant increase in both the curiosity (p = 0.008) and decentering (p = 0.01) scores of the Toronto Mindfulness Scale, all of which had medium to large effect sizes. Only the increases in curiosity and decentering were significant between groups. Fourteen mothers found the intervention acceptable, one neutral.ConclusionMKC was acceptable, feasible and led to a reduction in stress, anxiety and depression in mothers who practiced mindfulness exercises during KC.
Project description:BACKGROUND:Mindfulness-based interventions, self-compassion training, and cognitive behavioral therapy have garnered much evidence in its salutary effects on mental health. With increasing application of smartphone and mobile technology on health promotion, this study investigated the efficacy and possible moderators of mindfulness, self-compassion, and cognitive behavioral psychoeducation training mobile apps in the improvement of mental health. OBJECTIVE:The aim of this study was to examine the efficacy of 3 mobile app-based programs: mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation program in improving mental well-being and reducing psychological distress. Changes in mindful awareness and self-compassion were also assessed. To further delineate the suitability of each program for different types of individuals, individual difference variables (ie, discomfort with emotions and tolerance for ambiguity) were explored for potential moderation. METHODS:This study was a 3-arm, randomized, controlled, noninferiority trial examining the efficacy of mindfulness-based program, self-compassion program, and cognitive behavioral psychoeducation. Participants were randomized into either 1 of the 3 conditions. Throughout the 4-week, 28-session program, participants spent 10-15 min daily reviewing the course content and practicing various related exercises. At preprogram, postprogram, and 3-month follow-up, participants also completed Web-based measures of mental well-being, psychological distress, mindful-awareness, and self-compassion as well as the proposed moderators. RESULTS:Among the 2161 study participants, 508 and 349 completed the post- and 3-month follow-up assessment, respectively. All 3 conditions (mindfulness-based program: N=703; cognitive behavioral psychoeducation: N=753; self-compassion program: N=705) were found to be efficacious in improving mental well-being and reducing psychological distress. All conditions enhanced mindful awareness at postprogram. Significant interaction effect was found on self-compassion; cognitive behavioral psychoeducation and self-compassion program, but not mindfulness-based program, significantly enhanced self-compassion at postprogram. No significant differences regarding usage and users' satisfaction were found among the 3 conditions. None of the proposed moderators were found to be significant. CONCLUSIONS:Mindfulness-based, self-compassion, and cognitive behavioral psychoeducation mobile apps were efficacious in improving mental well-being and reducing psychological distress among adults at postprogram and 3-month follow-up. Future app-based psychological training programs should consider gamification and personalization of content or feedback to enhance engagement and mitigate the high attrition rates that are common in app-based health promotion programs. TRIAL REGISTRATION:Chinese Clinical Trial Registry (ChiCTR) ChiCTR-TRC-13003468; http://www.chictr.org.cn/hvshowproject.aspx?id=6220 (Archived by WebCite at http://www.webcitation.org/734PlOz50).
Project description:Mindfulness training is a novel method of leader development but contrary to its rising popularity, there is a scarcity of research investigating how mindfulness training may affect leader capabilities. To gain a better understanding of the potential of a new research field, qualitative research is advantageous. We sought to understand how senior leaders experience the impact of mindfulness training in their work lives and leadership ability. The sample comprised 13 leaders (n = 11 male) working in six organizations that completed a 10-week workplace mindfulness training (WMT). We conducted semi-structured interviews 6 to 12 months following course completion. We analyzed the data following thematic analysis steps and based on these findings, we devised a framework of the perceived impact of mindfulness training on self-leadership and leadership capabilities. We show that WMT exhibited impact on three self-leadership capacities: mindful task management, self-care and self-reflection and two leadership capacities: relating to others and adapting to change. Participants' recounts additionally suggested effects may expand to the level of the team and the organization. We show that WMT may be a promising tool for self-directed leadership development and outline avenues for future research.
Project description:We report results of a pilot study designed to test a novel smoking cessation intervention, Mindfulness Training for Smokers (MTS), in smokers age 18-29 years with regular episodes of binge drinking. Mindfulness is a cognitive skill of applying close moment-to-moment attention to experience with a mental posture of acceptance and non-reactivity. The MTS intervention consisted of six weekly classes that provided instruction on how to use mindfulness to manage known precursors of smoking relapse including smoking triggers, strong emotions, stressful situations, addictive thoughts, urges, and withdrawal symptoms.The MTS intervention was compared to Interactive Learning for Smokers (ILS), a time/intensity matched control group using daily non-directed walking instead of mindfulness meditation. Recruitment was conducted primarily at local technical colleges. Primary outcome measures included biochemically-confirmed smoking abstinence and reduction in alcohol use at the end of treatment (2-weeks post-quit attempt).The sample (N = 55) was 70.9% male, with a mean age of 21.9 years, and a mean of 11.76 alcoholic drinks consumed per week. Intent-to-treat analysis showed biochemically-confirmed 7-day point prevalence abstinence rates at 2-weeks post-quit for MTS = 20.0% and ILS = 4.0%, p = .08. Secondary analysis showed number of drinks per week in the first 2-weeks post-quit correlated with smoking relapse at 2-weeks post-quit (p?<?.01).This pilot study demonstrated that Mindfulness Training for Smokers shows promise for smoking cessation and alcohol use reduction in treating young adult smokers with alcohol abuse. Results suggest the need for a study with larger sample size and methods that reduce attrition.ClnicalTrial.gov, NCT01679236.
Project description:INTRODUCTION:Despite increasing evidence that aerobic exercise and cognitive training improve cognitive function among patients with cognitive impairment and dementia, few studies have focused on the effect of a combination of these approaches. This study will explore whether combining aerobic training (AT) with mindfulness training (MT), an intervention promoting the moment-to-moment awareness of physical sensations, affective states, and thoughts, improves cognitive function in individuals at risk of dementia. The primary objective is to determine the feasibility and acceptability of the intervention(s). The secondary objective is to obtain estimates of effect sizes on cognitive function and on possible mediators. METHODS AND ANALYSIS:Forty participants with at least 2 risk factors for dementia will be randomized (2?×?2 factorial design) to either AT (3?sessions/week for 12 weeks), MT (1?session/week for 8 weeks), both, or usual care. Assessments of cognitive function (attention, executive function, episodic, and working memory); physical activity (accelerometry), aerobic capacity (6-minute walk test), waist-to-hip ratio, blood pressure, social support (Multidimensional Scale of Perceived Social Support), depression (Hospital Anxiety and Depression Scale), and mindfulness (Five Facets of Mindfulness) will be conducted at baseline, end of treatment, and 6-months postbaseline. Rates of retention, attendance, and program satisfaction will be calculated for each of the 4 groups to determine the feasibility and acceptability of each intervention. ETHICS AND DISSEMINATION:This study has full ethical approval by The Miriam Hospital Institutional Review Board and adheres to the Standard Protocol Items: Recommendations for Interventional Trials reporting recommendations. If results from this exploratory, proof-of-concept study support our hypotheses, we will conduct a large randomized controlled trial (RCT) to determine the efficacy of combined MT and AT in improving cognitive function in individuals at risk of dementia. Results from the study will be disseminated through peer-reviewed journals and conference presentations. REGISTRATION DETAILS:: http://www.clinicalstrials.gov identifier NCT03289546.
Project description:BackgroundStress can negatively impact an individual's health and well-being and high levels of stress are noted to exist among college students today. While traditional treatment methods are plagued with stigma and transfer problems, newly developed wearable biofeedback devices may offer unexplored possibilities. Although these products are becoming commonplace and inexpensive, scientific evidence of the effectiveness of these products is scarce and their feasibility within research contexts are relatively unexplored. Conversely, companies are not required, and possibly reluctant, to release information on the efficacy of these products against their claims. Thus, in the present pilot, we assess the feasibility of using a real-time respiratory-based biofeedback device in preparation for a larger study. Our main aims were to assess device-adherence and collaboration with the company that develops and sells the device.MethodData were collected from 39 college students who self-identified as experiencing chronic stress at a Southwestern university in the USA. Students were randomized into either a mindfulness-only control group without a biofeedback device (n = 21), or an experimental group with biofeedback device (n = 18). Both groups received mindfulness meditation training. Pre-test and post-test procedures were conducted 2 weeks apart. Further, both participant compliance and company compliance were assessed and collaboration with the company was evaluated.ResultsParticipant device-adherence as well as the company's collaboration necessary for a full-scale study was determined to be low. This may also have affected our results which showed a strong main effect for time for all outcome variables, suggesting all groups showed improvement in their levels of stress after the intervention period. No group by time effects were identified, however, indicating no added benefit of the biofeedback device.ConclusionsOur findings suggest feasibility of future studies requires full collaboration and detailed and agreed upon data sharing procedures with the biofeedback company. The particular device under investigation added no value to the intervention outcomes and it was not feasible to continue a larger-scale study. Further, as the technology sector is innovating faster than it can validate products, we urge for open science collaborations between public and private sectors to properly develop evidence-based regulations that can withstand technological innovation while maintaining product quality, safety, and effectiveness.Trial registrationNCT02837016 . Registered 19 July 2016.
Project description:IntroductionAttention Deficit Hyperactivity Disorder (ADHD) has a global mean prevalence of 5%. Cognitive Training (CT) and Mindfulness-Based Interventions (MBIs) have shown promising results in managing ADHD symptoms, but they are not its Treatment-As-Usual (TAU). The NeuroMind Study aims to evaluate the preliminary effectiveness and feasibility of three interventions: Mindfulness for Health (M4H), CT using the NeuronUP® platform (CT), and a combination of both, Mindfulness Cognitive Training (MCT). There is empirical evidence supporting the effectiveness of the M4H and NeuronUP® platform; however, this study explores for the first time the effectiveness of MCT and CT, as well as the integration of M4H into TAU. The objectives of this 5-month Randomized Controlled Trial (RCT) are: (1) To analyze the preliminary effectiveness and feasibility of M4H, CT or a combination of both (MCT) added to TAU for children with ADHD; (2) To evaluate the role of psychological process variables (mindfulness and emotional regulation) as mediators of 5-month follow-up clinical outcomes; (3) To preliminarily explore whether specific sociodemographic and clinical characteristics can predict the short-and medium-term clinical response to the specific treatments.Methods and analysisParticipants will be 120 children (7 to 12 years) with ADHD recruited at Child and Adolescent Mental Health Service (CAMHS) Sant Joan de Déu Terres de Lleida (Spain) randomly allocated to one of the four study arms: TAU vs. TAU + CT vs. TAU + M4H vs. TAU + MCT. An assessment to collect ADHD symptoms, Executive Functions (EF), comorbid symptoms and global functioning will be conducted pre-intervention, post-intervention (2 months after baseline) and at the 5-month follow-up. Linear mixed models and mediational models will be computed.DiscussionIf the preliminary effectiveness and feasibility of the MCT are demonstrated, this study could be a preliminary basis to do a full RCT with a larger sample to definitively validate the intervention. The MCT could be applied in clinical practice if it is definitively validated.Clinical trial registration:ClinicalTrials.gov, identifier, NCT05937347. https://clinicaltrials.gov/study/NCT05937347?locStr=Spain&country=Spain&cond=ADHD&intr=Mindfulness&rank=1.
Project description:BackgroundInterventions based on meditation and mindfulness techniques have been shown to reduce stress and increase psychological well-being in a wide variety of populations. Self-administrated Internet-based mindfulness training programs have the potential to be a convenient, cost-effective, easily disseminated, and accessible alternative to group-based programs.ObjectiveThis randomized controlled pilot trial with 90 university students in Stockholm, Sweden, explored the feasibility, usability, acceptability, and outcomes of an 8-week Internet-based mindfulness training program.MethodsParticipants were randomly assigned to either an intervention (n=46) or an active control condition (n=44). Intervention participants were invited to an Internet-based 8-week mindfulness program, and control participants were invited to an Internet-based 4-week expressive writing program. The programs were automated apart from weekly reminders via email. Main outcomes in pre- and postassessments were psychological well-being and depression symptoms. To assess the participant's experiences, those completing the full programs were asked to fill out an assessment questionnaire and 8 of the participants were interviewed using a semistructured interview guide. Descriptive and inferential statistics, as well as content analysis, were performed.ResultsIn the mindfulness program, 28 out of 46 students (60%) completed the first week and 18 out of 46 (39%) completed the full program. In the expressive writing program, 35 out of 44 students (80%) completed the first week and 31 out of 44 (70%) completed the full program. There was no statistically significantly stronger intervention effect for the mindfulness intervention compared to the active control intervention. Those completing the mindfulness group reported high satisfaction with the program. Most of those interviewed were satisfied with the layout and technique and with the support provided by the study coordinators. More frequent contact with study coordinators was suggested as a way to improve program adherence and completion. Most participants considered the program to be meaningful and helpful but also challenging. The flexibility in performing the exercises at a suitable time and place was appreciated. A major difficulty was, however, finding enough time to practice.ConclusionsThe program was usable, acceptable, and showed potential for increasing psychological well-being for those completing it. However, additional modification of the program might be needed to increase retention and compliance.ClinicaltrialClinicalTrials.gov NCT02062762; https://clinicaltrials.gov/ct2/show/NCT0206276 (Archived by WebCite at http://www.webcitation.org/6j9I5SGJ4).
Project description:ImportanceAmong surgical trainees, burnout and distress are prevalent, but mindfulness has been shown to decrease the risk of depression, suicidal ideation, burnout, and overwhelming stress. In other high-stress populations, formal mindfulness training has been shown to improve mental health, yet this approach has not been tried in surgery.ObjectiveTo test the feasibility and acceptability of modified Mindfulness-Based Stress Reduction (MBSR) training during surgical residency.Design, setting, and participantsA pilot randomized clinical trial of modified MBSR vs an active control was conducted with 21 surgical interns in a residency training program at a tertiary academic medical center, from April 30, 2016, to December 2017.InterventionsWeekly 2-hour, modified MBSR classes and 20 minutes of suggested daily home practice over an 8-week period.Main outcomes and measuresFeasibility was assessed along 6 domains (demand, implementation, practicality, acceptability, adaptation, and integration), using focus groups, interviews, surveys, attendance, daily practice time, and subjective self-report of experience.ResultsOf the 21 residents included in the analysis, 13 were men (62%). Mean (SD [range]) age of the intervention group was 29.0 (2.4 [24-31]) years, and the mean (SD [range]) age of the control group was 27.4 (2.1 [27-33]) years. Formal stress-resilience training was feasible through cultivation of stakeholder support. Modified MBSR was acceptable as evidenced by no attrition; high attendance (12 of 96 absences [13%] in the intervention group and 11 of 72 absences [15%] in the control group); no significant difference in days per week practiced between groups; similar mean (SD) daily practice time between groups with significant differences only in week 1 (control, 28.15 [12.55] minutes; intervention, 15.47 [4.06] minutes; P = .02), week 2 (control, 23.89 [12.93] minutes; intervention, 12.61 [6.06] minutes; P = .03), and week 4 (control, 26.26 [13.12] minutes; intervention, 15.36 [6.13] minutes; P = .04); course satisfaction (based on interviews and focus group feedback); and posttraining-perceived credibility (control, 18.00 [4.24]; intervention, 20.00 [6.55]; P = .03). Mindfulness skills were integrated into personal and professional settings and the independent practice of mindfulness skills continued over 12 months of follow-up (mean days [SD] per week formal practice, 3 [1.0]).Conclusions and relevanceFormal MBSR training is feasible and acceptable to surgical interns at a tertiary academic center. Interns found the concepts and skills useful both personally and professionally and participation had no detrimental effect on their surgical training or patient care.Trial registrationClinicalTrials.gov identifier: NCT03141190.
Project description:Cognitive impairments are common in homeless youth and negatively impact academic and vocational outcomes. We examined the feasibility and efficacy of cognitive interventions provided to 18- to 22-year-old homeless youth living in urban supportive housing. Ninety-one homeless youth were randomized to receive either targeted cognitive training (cognitive remediation) or general cognitive activation (computer skills training). Cognitive and psychological outcomes were assessed at baseline, after 13 and 26 sessions, and 1 month postintervention. A high dropout rate highlighted the feasibility challenges of treating this population. Intent-to-treat analysis found significant improvements across groups in specific and global measures of cognition and psychological distress, with no significant group differences. Transition-age homeless youth show improvements in cognitive and psychological functioning when engaged in interventions that address their cognitive development. This speaks to the malleability of cognitive skills in this cohort and lays the groundwork for future research to address their cognitive health.