Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial

Abstract

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

Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review (Preprint)

“…pain interference, pain catastrophizing, pain coping efficacy and pain acceptance) in four studies [41,42,47,49]; depression in three studies [44,46,48], distress in two studies [47,49], exercise capacity [36], anxiety [43] and mood disturbance [45]. Five studies did not distinguish a primary outcome measure from their overall measures [41,42,[47][48][49], which included construct related to stress, affect, and quality of life.…”

“…Title screening excluded 643 records leaving 48 abstracts that were examined, with 14 selected for full review. Two papers reported on findings from the same trial, one reported on the efficacy of the intervention to improve physical and psychological outcomes post-intervention [36], and the other reported the 12-month follow-up assessment [37]. Both papers were included, but the methodology and findings were presented as one study.…”

“…a primary outcome was feasibility, but sample size was calculated with adequate power to reducing mood disturbance (secondary outcome) OCD = Obsessive compulsive disorder; QE = Quasi-Experimental, QoL = Quality of Life; FU = follow up Studies were published from 2008 and conducted in Sweden (n=3); [43,44,49], Canada (n=2); [41,45], the United States (n=2) [42,46], the Netherlands (n=1); [36], Ireland (n=1); [47] and Germany (n=1); [48]. Eight studies were RCTs [36,[42][43][44][45][47][48][49], and two were quasi experimental design [41,46]. Most studies involved female participants with an overall mean of 74.8%, ranging between 46.3% [36] and 98% [42].…”

“…Eight studies were RCTs [36,[42][43][44][45][47][48][49], and two were quasi experimental design [41,46]. Most studies involved female participants with an overall mean of 74.8%, ranging between 46.3% [36] and 98% [42]. The overall mean age of participants was 45 years (mean age range: 36 -57.6 years).…”

“…Three studies comprised active comparison groups, including the same MBI delivered in person [41], a web-based behavioural activation condition [44], and a progressive muscle relaxation program [48]. Control conditions were attention control (n=1) [42], online discussion forum (n=2) [43,49], psychoeducational (n=1) [47], wait-list (n=2) [41,45] or usual care (n=2) [36,46]. One study involved two comparison groups [41].…”