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.
Project description:Patients who have received solid organ transplants continue to experience a myriad of complex symptoms related to their underlying disease and to chronic immunosuppression that reduce the quality of life. Beneficial nonpharmacologic therapies to address these symptoms have not been established in the transplant population.Assess the efficacy of mindfulness-based stress reduction (MBSR) in reducing symptoms of anxiety, depression, and poor sleep in transplant patients.Controlled trial with a two-staged randomization. Recipients of kidney, kidney/pancreas, liver, heart, or lung transplants were randomized to MBSR (n=72) or health education (n=66) initially or after serving in a waitlist. Mean age was 54 years (range 21-75); 55% were men, and 91% were white.MBSR, a mindfulness meditation training program consisting of eight weekly 2.5-hour classes; health education, a peer-led active control.Anxiety (State-Trait Anxiety Inventory), depression (Center for Epidemiologic Studies Depression Scale), and sleep quality (Pittsburgh Sleep Quality Index) scales assessed by self-report at baseline, 8 weeks, 6 months, and 1 year.Benefits of MBSR were above and beyond those afforded by the active control. MBSR reduced anxiety and sleep symptoms (P < .02), with medium treatment effects (.51 and .56) at 1 year compared to health education in intention-to-treat analyses. Within the MBSR group, anxiety, depression, and sleep symptoms decreased and quality-of-life measures improved by 8 weeks (P < .01, all), and benefits were retained at 1 year (P < .05, all). Initial symptom reductions in the health education group were smaller and not sustained. Comparisons to the waitlist confirmed the impact of MBSR on both symptoms and quality of life, whereas health education improvements were limited to quality-of-life ratings.MBSR reduced distressing symptoms of anxiety, depression, and poor sleep and improved quality of life. Benefits were sustained over 1 year. A health education program provided fewer benefits, and effects were not as durable. MBSR is a relatively inexpensive, safe, and effective community-based intervention.
Project description:The current study attempted a rigorous test of the construct validity of a widely used self-report measure of dispositional mindfulness, the Five Facet Mindfulness Questionnaire (FFMQ), within the context of an active controlled randomized trial (n = 130). The trial included three arms: mindfulness-based stress reduction (MBSR), an active control condition that did not include instruction in mindfulness meditation (Health Enhancement Program [HEP]), and a waitlist control condition. Partial evidence for the convergent validity of the FFMQ was shown in correlations at baseline between FFMQ facets and measures of psychological symptoms and psychological well-being. In addition, facets of the FFMQ were shown to increase over the course of an MBSR intervention relative to a waitlist control condition. However, the FFMQ failed to show discriminant validity. Specifically, facets of the FFMQ were shown to increase over the course of the HEP intervention relative to the waitlist control condition. MBSR and HEP, in contrast, did not differ in changes in FFMQ score over time. Implications of these findings for the measurement and theory of mindfulness and MBSR are discussed. (PsycINFO Database Record
Project description:Mindfulness meditation training has been shown to increase resting-state functional connectivity between nodes of the frontoparietal executive control network (dorsolateral prefrontal cortex [DLPFC]) and the default mode network (posterior cingulate cortex [PCC]). We investigated whether these effects generalized to a Mindfulness-Based Stress Reduction (MBSR) course and tested for structural and behaviorally relevant consequences of change in connectivity. Healthy, meditation-naïve adults were randomized to either MBSR (N =?48), an active (N =?47) or waitlist (N =?45) control group. Participants completed behavioral testing, resting-state fMRI scans and diffusion tensor scans at pre-randomization (T1), post-intervention (T2) and ~5.5 months later (T3). We found increased T2-T1 PCC-DLPFC resting connectivity for MBSR relative to control groups. Although these effects did not persist through long-term follow-up (T3-T1), MBSR participants showed a significantly stronger relationship between days of practice (T1 to T3) and increased PCC-DLPFC resting connectivity than participants in the active control group. Increased PCC-DLPFC resting connectivity in MBSR participants was associated with increased microstructural connectivity of a white matter tract connecting these regions and increased self-reported attention. These data show that MBSR increases PCC-DLPFC resting connectivity, which is related to increased practice time, attention and structural connectivity.
Project description:BACKGROUND:Practice of meditation or exercise may enhance health to protect against acute infectious illness. OBJECTIVE:To assess preventive effects of meditation and exercise on acute respiratory infection (ARI) illness. DESIGN:Randomized controlled prevention trial with three parallel groups. SETTING:Madison, Wisconsin, USA. PARTICIPANTS:Community-recruited adults who did not regularly exercise or meditate. METHODS:1) 8-week behavioral training in mindfulness-based stress reduction (MBSR); 2) matched 8-week training in moderate intensity sustained exercise (EX); or 3) observational waitlist control. Training classes occurred in September and October, with weekly ARI surveillance through May. Incidence, duration, and area-under-curve ARI global severity were measured using daily reports on the WURSS-24 during ARI illness. Viruses were identified multiplex PCR. Absenteeism, health care utilization, and psychosocial health self-report assessments were also employed. RESULTS:Of 413 participants randomized, 390 completed the trial. In the MBSR group, 74 experienced 112 ARI episodes with 1045 days of ARI illness. Among exercisers, 84 had 120 episodes totaling 1010 illness days. Eighty-two of the controls had 134 episodes with 1210 days of ARI illness. Mean global severity was 315 for MBSR (95% confidence interval 244, 386), 256 (193, 318) for EX, and 336 (268, 403) for controls. A prespecified multivariate zero-inflated regression model suggested reduced incidence for MBSR (p = 0.036) and lower global severity for EX (p = 0.042), compared to control, not quite attaining the p<0.025 prespecified cut-off for null hypothesis rejection. There were 73 ARI-related missed-work days and 22 ARI-related health care visits in the MBSR group, 82 days and 21 visits for exercisers, and 105 days and 24 visits among controls. Viruses were identified in 63 ARI episodes in the MBSR group, compared to 64 for EX and 72 for control. Statistically significant (p<0.05) improvements in general mental health, self-efficacy, mindful attention, sleep quality, perceived stress, and depressive symptoms were observed in the MBSR and/or EX groups, compared to control. CONCLUSIONS:Training in mindfulness meditation or exercise may help protect against ARI illness. LIMITATIONS:This trial was likely underpowered. TRIAL REGISTRATION:Clinicaltrials.gov NCT01654289.
Project description:Mindfulness meditation training has stress reduction benefits in various patient populations, but its effects on biological markers of HIV-1 progression are unknown. The present study tested the efficacy of an 8-week Mindfulness-based stress reduction (MBSR) meditation program compared to a 1-day control seminar on CD4+ T lymphocyte counts in stressed HIV infected adults. A single-blind randomized controlled trial was conducted with enrollment and follow-up occurring between November 2005 and December 2007. A diverse community sample of 48 HIV-1 infected adults was randomized and entered treatment in either an 8-week MBSR or a 1-day control stress reduction education seminar. The primary outcome was circulating counts of CD4+ T lymphocytes. Participants in the 1-day control seminar showed declines in CD4+ T lymphocyte counts whereas counts among participants in the 8-week MBSR program were unchanged from baseline to post-intervention (time x treatment condition interaction, p=.02). This effect was independent of antiretroviral (ARV) medication use. Additional analyses indicated that treatment adherence to the mindfulness meditation program, as measured by class attendance, mediated the effects of mindfulness meditation training on buffering CD4+ T lymphocyte declines. These findings provide an initial indication that mindfulness meditation training can buffer CD4+ T lymphocyte declines in HIV-1 infected adults.clinicaltrials.gov, Identifier: NCT00600561.
Project description:Chronic insomnia is a major public health problem affecting approximately 10% of adults. Use of meditation and yoga to develop mindful awareness ('mindfulness training') may be an effective approach to treat chronic insomnia, with sleep outcomes comparable to nightly use of prescription sedatives, but more durable and with minimal or no side effects. The purpose of this study was to understand mindfulness training as experienced by patients with chronic insomnia, and suggest procedures that may be useful in optimizing sleep benefits.Adults (N?=?18) who completed an 8-week mindfulness-based stress reduction (MBSR) program as part of a randomized, controlled clinical trial to evaluate MBSR as a treatment for chronic insomnia were invited to participate in post-trial focus groups. Two groups were held. Participants (n?=?9) described how their sleep routine, thoughts and emotions were affected by MBSR and about utility (or not) of various mindfulness techniques. Groups were audio-recorded, transcribed and analyzed using content analysis.Four themes were identified: the impact of mindfulness on sleep and motivation to adopt a healthy sleep lifestyle; benefits of mindfulness on aspects of life beyond sleep; challenges and successes in adopting mindfulness-based practices; and the importance of group sharing and support. Participants said they were not sleeping more, but sleeping better, waking more refreshed, feeling less distressed about insomnia, and better able to cope when it occurred. Some participants experienced the course as a call to action, and for them, practicing meditation and following sleep hygiene guidelines became priorities. Motivation to sustain behavioral changes was reinforced by feeling physically better and more emotionally stable, and seeing others in the MBSR class improve. The body scan was identified as an effective tool to enable falling asleep faster. Participants described needing to continue practicing mindfulness to maintain benefits.First-person accounts are consistent with published trial results of positive impacts of MBSR on sleep measured by sleep diary, actigraphy, and self-report sleep scales. Findings indicate that mindfulness training in a group format, combined with sleep hygiene education, is important for effective application of MBSR as a treatment for chronic insomnia.
Project description:Mindfulness Based Stress Reduction (MBSR) is a secular form of meditation training. The vast majority of the extant literature investigating the health effects of mindfulness interventions relies on wait-list control comparisons. Previous studies have found that meditation training over several months is associated with improvements in cognitive control and attention.We used a visual continuous performance task (CPT) to test the effects of eight weeks of mindfulness training on sustained attention by comparing MBSR to the Health Enhancement Program (HEP), a structurally equivalent, active control condition in a randomized, longitudinal design (ClinicalTrials.gov, NCT01301105) focusing on a non-clinical population typical of MBSR participants. Researchers were blind to group assignment. 63 community participants were randomized to either MBSR (n?=?31) or HEP (n?=?32). CPT analyses were conducted on 29 MBSR participants and 25 HEP participants. We predicted that MBSR would improve visual discrimination ability and sustained attention over time on the CPT compared to HEP, with more home practice associated with greater improvements. Our hypotheses were not confirmed but we did find some evidence for improved visual discrimination similar to effects in partial replication of other research. Our study had sufficient power to demonstrate that intervention groups do not differ in their improvement over time in sustained attention performance. One of our primary predictions concerning the effects of intervention on attentional fatigue was significant but not interpretable.Attentional sensitivity is not affected by mindfulness practice as taught in MBSR, but it is unclear whether mindfulness might positively affect another aspect of attention, vigilance. These results also highlight the relevant procedural modifications required by future research to correctly investigate the role of sustained attention in similar samples.ClinicalTrials.gov, NCT01301105.
Project description:Mindfulness training has been shown to have a beneficial effect on cognitive flexibility. However, little is known about the mediators that produce this effect. Cross-sectional studies show that there might be a link between Non-judgment, Non-reactivity and cognitive flexibility. Longitudinal studies examining whether Non-judgment or Non-reactivity mediate the effectiveness of mindfulness training on improving cognitive flexibility are lacking. The present study aims to test the effect of mindfulness training on increasing cognitive flexibility and to test whether this effect is mediated by Non-judgment or Non-reactivity. We conducted a single-blind randomized controlled trial in 54 nonclinical high-stress participants between October 2018 and January 2019. Participants were randomly assigned to a Mindfulness Based Stress Reduction (MBSR) group or a waitlist control group. The experimenters were blind to the group assignment of participants. The MBSR group received 8-weekly sessions (2.5-h per week) and a one-day retreat (6-h), and was required to accomplish a 45-min daily formal practice during the intervention. The waitlist control group did not receive any intervention during the waiting period and received a 2-day (6-h per day) mindfulness training after the post-intervention. The primary outcome was self-report cognitive flexibility and perceived stress administered before and after MBSR. The secondary outcome was self-report mindfulness skills (including Non-reactivity and Non-judgment) measured at pre-treatment, Week 3, Week 6, and post-intervention. For cognitive flexibility, mixed-model repeated-measure ANOVA results showed that there were significant main effects of Time, Group and a significant interaction of Time by Group. Follow-up ANOVA indicated that the MBSR group was associated with greater improvements in cognitive flexibility than the waitlist. Path analysis results showed that the effect of the treatment on cognitive flexibility at post-treatment was fully mediated by Non-reactivity at Week 6. The mediation effects of Non-reactivity at Week 3, and Non-judgment at Week 3 and Week 6 were not significant. Our findings support the efficacy of MBSR on improving cognitive flexibility. Non-reactivity is an important element of the effectiveness of MBSR training on cognitive flexibility.
Project description:Patients with progressive kidney disease experience increasing physiologic and psychosocial stressors and declining health-related quality of life (HRQOL).We conducted a randomized, active-controlled, open-label trial to test whether a Mindfulness-based Stress Reduction (MBSR) program delivered in a novel workshop-teleconference format would reduce symptoms and improve HRQOL in patients awaiting kidney transplantation. Sixty-three transplant candidates were randomized to one of two arms: i) telephone-adapted MBSR (tMBSR, an 8-week program of meditation and yoga); or ii) a telephone-based support group (tSupport). Participants completed self-report questionnaires at baseline, post-intervention, and after 6-months. Anxiety, measured by the State-Trait Anxiety Inventory (STAI) post-intervention served as the primary outcome. Secondary outcomes included: depression, sleep quality, pain, fatigue, and HRQOL assessed by SF-12 Physical and Mental Component Summaries (PCS, MCS).55 patients (age 54±12yrs) attended their assigned program (tMBSR, n=27; tSupport, n=28). 49% of patients had elevated anxiety at baseline. Changes in anxiety were small and did not differ by treatment group post-intervention or at follow-up. However, tMBSR significantly improved mental HRQOL at follow-up: +6.2 points on the MCS - twice the minimum clinically important difference (95% CI: 1.66 to 10.8, P=0.01). A large percentage of tMBSR participants (?90%) practiced mindfulness and reported it helpful for stress management.Neither mindfulness training nor a support group resulted in clinically meaningful reductions in anxiety. In contrast, finding that tMBSR was more effective than tSupport for bolstering mental HRQOL during the wait for a kidney transplant is encouraging and warrants further investigation. ClinicalTrials.govNCT01254214.
Project description:Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents.To determine the effectiveness of MBSR in reducing burnout in residents.A randomized controlled trial comparing MBSR with a waitlist control group.Residents from all medical, surgical and primary care disciplines were eligible to participate. Participants were self-referred.The MBSR consisted of eight weekly 2.5-h sessions and one 6-h silent day.The primary outcome was the emotional exhaustion subscale of the Dutch version of the Maslach Burnout Inventory-Human Service Survey. Secondary outcomes included the depersonalization and reduced personal accomplishment subscales of burnout, worry, work-home interference, mindfulness skills, self-compassion, positive mental health, empathy and medical errors. Assessment took place at baseline and post-intervention approximately 3 months later.Of the 148 residents participating, 138 (93%) completed the post-intervention assessment. No significant difference in emotional exhaustion was found between the two groups. However, the MBSR group reported significantly greater improvements than the control group in personal accomplishment (p?=?0.028, d?=?0.24), worry (p?=?0.036, d?=?0.23), mindfulness skills (p?=?0.010, d?=?0.33), self-compassion (p?=?0.010, d?=?0.35) and perspective-taking (empathy) (p?=?0.025, d?=?0.33). No effects were found for the other measures. Exploratory moderation analysis showed that the intervention outcome was moderated by baseline severity of emotional exhaustion; those with greater emotional exhaustion did seem to benefit.The results of our primary outcome analysis did not support the effectiveness of MBSR for reducing emotional exhaustion in residents. However, residents with high baseline levels of emotional exhaustion did appear to benefit from MBSR. Furthermore, they demonstrated modest improvements in personal accomplishment, worry, mindfulness skills, self-compassion and perspective-taking. More research is needed to confirm these results.