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Web-based mindfulness intervention in heart disease: a randomized controlled trial
Younge JO, Wery MF, Gotink RA, Utens EMWJ, Michels M, Rizopoulos D, van Rossum EFC, Hunink MGM, Roos-Hesselink JW
PLoS ONE 2015 Dec;10(12):e0143843
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease. METHODS: The study was a pragmatic randomized controlled single-blind trial. Between June 2012 and April 2014 we randomized 324 patients (mean age 43.2 years, 53.7% male) with heart disease in a 2:1 ratio (n = 215 versus n = 109) to a 12-week online mindfulness training in addition to usual care (UC) compared to UC alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT). Secondary outcomes were other physiological parameters (heart rate, blood pressure, respiratory rate, and NT-proBNP), subjective health status (SF-36), perceived stress (PSS), psychological well-being (HADS), social support (PSSS12) and a composite endpoint (all-cause mortality, heart failure, symptomatic arrhythmia, cardiac surgery, and percutaneous cardiac intervention). Linear mixed models were used to evaluate differences between groups on the repeated outcome measures. RESULTS: Compared to UC, mindfulness showed a borderline significant improved 6MWT (effect size meters 13.2, 95%CI -0.02 to 26.4, p = 0.050). There was also a significant lower heart rate in favor of the mindfulness group (effect size beats per minute -2.8, 95%CI -5.4 to -0.2, p = 0.033). No significant differences were seen on other outcomes. CONCLUSIONS: Mindfulness training showed positive effects on the physiological parameters exercise capacity and heart rate and it might therefore be a useful adjunct to current clinical therapy in patients with heart disease. TRIAL REGISTRATION: Dutch Trial Register NTR3453.

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