Purpose Mindfulness has emerged as an important health concept based on evidence that mindfulness interventions reduce symptoms and improve health-related quality of life. The objectives of this study were to systematically assess and compare the properties of instruments to measure self-reported mindfulness. Methods Ovid Medline®, CINAHL®, and PsycINFO® were searched through May 2012, and articles were selected if their primary purpose was development or evaluation of the measurement properties (validity, reliability, responsiveness) of a self-report mindfulness scale. Two reviewers independently evaluated the methodological quality of the selected studies using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. Discrepancies were discussed with a third reviewer, and scored by consensus. Finally, a level of evidence approach was used to synthesize results and study quality. Results Our search strategy identified a total of 2,588 articles. Forty-six articles, reporting 79 unique studies, met inclusion criteria. Ten instruments quantifying mindfulness as a unidimensional scale (n=5) or as a set of 2 to 5 subscales (n=5) were reviewed. The Mindful Attention Awareness Scale (MAAS) was evaluated by the most studies (n=27), and had positive overall quality ratings for most of the psychometric properties reviewed. The Five Facet Mindfulness Questionnaire (FFMQ) received the highest possible rating (“consistent findings in multiple studies of good methodological quality”) for two properties, internal consistency and construct validation by hypothesis testing. However, none of the instruments had sufficient evidence of content validity. Comprehensiveness of construct coverage had not been assessed; qualitative methods to confirm understanding and relevance were absent. In addition, estimates of test-retest reliability, responsiveness, or measurement error to guide users in protocol development or interpretation of scores were lacking. Conclusions Current mindfulness scales have important conceptual differences, and none can be strongly recommended based solely on superior psychometric properties. Important limitations in the field are the absence of qualitative evaluations and accepted external referents to support construct validity. Investigators need to proceed cautiously before optimizing any mindfulness intervention based on the existing scales.
Objective To investigate the potential of Mindfulness-Based Stress Reduction (MBSR) as a treatment for chronic primary insomnia. Design Randomized controlled trial. Setting University health center. Patients 30 adults with primary chronic insomnia based on DSM-IV-TR criteria were randomized 2:1 to MBSR or pharmacotherapy (PCT). Interventions MBSR, a program of mindfulness meditation training consisting of 8 weekly 2.5 hour classes and a day-long retreat, with ongoing home meditation practice expectations during 3 month follow-up; PCT, consisting of 3 mg of eszopiclone (LUNESTA™) nightly for 8 weeks, followed by 3 months of use as needed. A 10-minute sleep hygiene presentation was included in both interventions. Main Outcomes The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diaries and wrist actigraphy collected pre-treatment, post-treatment (8 weeks), and at 5 months (self-reports only). Results Between baseline and 8-weeks, sleep onset latency measured by actigraphy decreased 8.9 minutes in the MBSR arm (P<.05). Large, significant improvements were found on the ISI, PSQI, and diary-measured total sleep time, sleep onset latency and sleep efficiency (Ps<.01, all) from baseline to 5 month follow-up in the MBSR arm. Changes of comparable magnitude were found in the PCT arm. 27 out of 30 patients completed their assigned treatment. This study provides initial evidence for the efficacy of MBSR as a viable treatment for chronic insomnia as measured by: sleep diary, actigraphy, well-validated sleep scales and measures of remission and clinical recovery.
BACKGROUND Patients with progressive kidney disease experience increasing physiologic and psychosocial stressors and declining health-related quality of life (HRQOL). METHODS 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). RESULTS 55 patients (age 54±12 yrs) 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. CONCLUSIONS 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.gov NCT01254214
Solid organ transplant recipients are at increased risk for poor sleep due to pharmacotherapy and co-morbidities, but sleep problems are often unrecognized and untreated. Study aims were to measure rates of occurrence, characteristics and correlates of poor sleep in recipients. The Pittsburgh Sleep Quality Index (PSQI) and sleep parameters measured by wrist actigraphy were obtained at baseline from 143 kidney, liver, heart, lung or pancreas transplant recipients enrolled in a psychosocial intervention trial to improve symptoms and quality of life. Rates of poor sleep were determined using accepted clinical cut-offs; 41% (58 of 143) were poor sleepers (PSQI >8) and 36% used sleep medications in the past month. 15% reported having obstructive sleep apnea and 4% reported restless legs syndrome. Based on actigraphy (n=73), 69% lacked sleep efficiency; 32% took greater than 30 minutes to fall asleep; 88% awakened during the night for more than 30 minutes; and 25% slept less than 6 hours per night. Obesity and use of psychotropics or sleep medications were independent risk factors for poor objectively-measured sleep. Poor sleep is an undertreated problem in transplantation. Screening for sleep problems and behavioral therapies with sleep hygiene instruction may benefit recipients.
Background Mindfulness-based stress reduction (MBSR) has demonstrated benefits for stress-related symptoms; however, for patients with burdensome treatment regimens, multiple co-morbidities and mobility impairment, time and travel requirements pose barriers to MBSR training. Purpose To describe the design, rationale and feasibility results of Journeys to Wellness, a clinical trial of mindfulness training delivered in a novel workshop and teleconference format. The trial aim is to reduce symptoms and improve quality of life in people waiting for a kidney transplant. Methods The standard 8-week MBSR program was reconfigured for delivery as two in-person workshops separated in time by six weekly teleconferences (tMBSR). A time and attention comparison condition (tSupport) was created using the workshop-telephone format. Feasibility results Kidney transplant candidates (N=63) were randomly assigned to tMBSR or tSupport: 87% (n=55) attended ≥1 class, and for these, attendance was high (6.6 ± 1.8 tMBSR and 7.0 ± 1.4 tSupport sessions). Fidelity monitoring found all treatment elements were delivered as planned and few technical problems occurred. Patients in both groups reported high treatment satisfaction, but more tMBSR (83%) than tSupport (43%) participants expected their intervention to be quite a bit or extremely useful for managing their health. Symptoms and quality of life outcomes collected before (baseline, 8 weeks and 6 months) and after kidney transplantation (2, 6 and 12 months) will be analyzed for efficacy. Conclusions tMBSR is an accessible intervention that may be useful to people with a wide spectrum of health conditions. Clinicaltrials.gov: NCT01254214
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