BackgroundEvidence 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.MethodsThe 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.ResultsCompared to UC, mindfulness showed a borderline significant improved 6MWT (effect size, meters: 13.2, 95%CI: -0.02; 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;-0.2, p = 0.033). No significant differences were seen on other outcomes.ConclusionsMindfulness 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 RegistrationDutch Trial Register 3453

There is increasing evidence that mindfulness can reduce stress, and thereby affect other psychological and physiological outcomes as well. Earlier, we reported the direct 3-month results of an online modified mindfulness-based stress reduction training in patients with heart disease, and now we evaluate the effect at 12-month follow-up. 324 patients (mean age 43.2 years, 53.7% male) were randomized in a 2:1 ratio to additional 3-month online mindfulness training or to usual care alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT). Secondary outcomes were blood pressure, heart rate, respiratory rate, NT-proBNP, cortisol levels (scalp hair sample), mental and physical functioning (SF-36), anxiety and depression (HADS), perceived stress (PSS), and social support (PSSS12). Differences between groups on the repeated outcome measures were analyzed with linear mixed models. At 12-months follow-up, participants showed a trend significant improvement exercise capacity (6MWT: 17.9 meters, p = 0.055) compared to UC. Cohen’s D showed significant but small improvement on exercise capacity (d = 0.22; 95%CI 0.05 to 0.39), systolic blood pressure (d = 0.19; 95%CI 0.03 to 0.36), mental functioning (d = 0.22; 95%CI 0.05 to 0.38) and depressive symptomatology (d = 0.18; 95%CI 0.02 to 0.35). All other outcome measures did not change statistically significantly. In the as-treated analysis, systolic blood pressure decreased significantly with 5.5 mmHg (p = 0.045; d = 0.23 (95%CI 0.05–0.41)). Online mindfulness training shows favorable albeit small long-term effects on exercise capacity, systolic blood pressure, mental functioning, and depressive symptomatology in patients with heart disease and might therefore be a beneficial addition to current clinical care.Trial registration: www.trialregister.nl NTR3453

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Objectives This study aims to evaluate the effectiveness of a "blended" workplace health-promotion intervention, alongside identification of key components beneficial for future implementation strategies. Methods Within a cluster randomized controlled trial, 491 employees at increased risk of cardiovascular disease were allocated to the limited (N=217; 9 clusters) or extensive (N=274; 8 clusters) intervention. The extensive intervention consisted of motivational interviewing (MI) within the framework of a web-based health risk assessment (HRA), a blended care approach. The limited intervention received solely the web-based HRA. Occupational health physicians (N=21) within three organizations delivered the intervention. Implementation components investigated included: HRA (reach and participation), newsletters (percentage read), and MI sessions (number and quality). MI quality was determined by scoring audiotaped MI sessions, using the MI treatment integrity code. After 6 and 12 months, effects on participation in health-promotion activities and its associations with components of implementation were determined by mixed-effects models. Results Over 80% of employees participated in health-promotion activities, with an additional 8% in the extensive compared to the limited group. In the extensive intervention, those with more or better quality MI sessions were more likely to participate in health-promotion activities. Increased MI quality was associated with sustained participation. Conclusions This study suggests that participation in health-promotion activities can be increased by adding MI to a web-based approach and improving the quality of the MI delivered. Interventions with MI should include optimized delivery and quality of MI sessions.