Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial.
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ABSTRACT: 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; 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.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 3453.
SUBMITTER: Younge JO
PROVIDER: S-EPMC4671576 | biostudies-literature | 2015
REPOSITORIES: biostudies-literature
Publications
Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial.
Younge John O JO Wery Machteld F MF Gotink Rinske A RA Utens Elisabeth M W J EM Michels Michelle M Rizopoulos Dimitris D van Rossum Elisabeth F C EF Hunink M G Myriam MG Roos-Hesselink Jolien W JW
PloS one 20151207 12
<h4>Background</h4>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.<h4>Methods</h4>The study was a pragmatic randomize ...[more]
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Project description:BACKGROUND:Innovative interventions are needed to address the increasing mental health needs of university students. Given the demonstrated anxiolytic and antidepressant benefits of mindfulness training, we developed an 8-week, Web-based Mindfulness Virtual Community (MVC) intervention informed by cognitive behavioral therapy (CBT) constructs. OBJECTIVE:This study investigated the efficacy of the MVC intervention in reducing symptoms of depression, anxiety, and stress among undergraduate students in Toronto, Canada. The secondary outcomes included quality of life, life satisfaction, and mindfulness. METHODS:The first 4 weeks of the full MVC intervention (F-MVC) comprised: (1) 12 video-based modules with psycho-education on students' preidentified stressful topics and topically applied mindfulness practice; (2) anonymous peer-to-peer discussion forums; and (3) anonymous, group-based, professionally guided, 20-min live videoconferences. The second 4 weeks of F-MVC involved access only to video-based modules. The 8-week partial MVC (P-MVC) comprised 12 video-based modules. A randomized controlled trial was conducted with 4 parallel arms: F-MVC, P-MVC, waitlist control (WLC), and group-based face-to-face CBT; results for the latter group are presented elsewhere. Students recruited through multiple strategies consented and were randomized: WLC=40; F-MVC=40, P-MVC=39; all learned about allocation after consenting. The online surveys at baseline (T1), 4 weeks (T2), and 8 weeks (T3) included the Patient Health Questionnaire-9 item, Beck Anxiety Inventory, Perceived Stress Scale, Quality of Life Scale, Brief Multi-Dimensional Students Life Satisfaction Scale, and Five-Facet Mindfulness Questionnaire. Analyses employed generalized estimation equation methods with AR(1) covariance structures and were adjusted for possible confounders (gender, age, birth country, paid work, unpaid work, physical activities, self-rated health, and mental health counseling access). RESULTS:Of the 113 students who provided T1 data, 28 were males and 85 were females with a mean age of 24.8 years. Participants in F-MVC (n=39), P-MVC (n=35), and WLC (n=39) groups were similar in sociodemographic characteristics at T1. At T3 follow-up, per adjusted comparisons, there were statistically significant reductions in depression scores for F-MVC (score change -4.03; P<.001) and P-MVC (score change -4.82; P<.001) when compared with WLC. At T3, there was a statistically significant reduction in anxiety scores only for P-MVC (score change -7.35; P=.01) when compared with WLC. There was a statistically significant reduction in scores for perceived stress for both F-MVC (score change -5.32; P<.001) and P-MVC (score change -5.61; P=.005) compared with WLC. There were statistically significant changes at T3 for quality of life and mindfulness for F-MVC and P-MVC vs WLC but not for life satisfaction. CONCLUSIONS:Internet-based mindfulness CBT-based interventions, such as F-MVC and P-MVC, can result in significant reductions in symptoms of depression, anxiety, and stress in a student population. Future research with a larger sample from multiple universities would more precisely test generalizability. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275.
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Project description:ObjectivesThe goal of the present study was to probe the effects of mindfulness practice in a naturalistic setting as opposed to a lab-based environment in the presence of continuous heart rate variability (HRV) measurements. The specific experimental goals were to examine the effects of a brief 10-day online-based mindfulness intervention on both chronic and acute HRV responses.MethodWe conducted a fully randomized 10-day longitudinal trial of mindfulness practice, explicitly controlling for practice effects with an active-control group (music listening) and a non-intervention control group. To assess chronic cardiovascular effects, we asked participants in the 3 groups to complete 2-day HRV pre- and post-intervention measurement sessions. Using this experimental setup enabled us to address training effects arising from mindfulness practice to assess physiological impact on daytime as well as nighttime (i.e. assessing sleep quality) on the underlying HRV response. To assess acute cardiovascular effects, we measured HRV in the 2 active intervention groups during each of the 10 daily mindfulness or music sessions. This allowed us to track the development of purported training effects arising from mindfulness practice relative to the active-control intervention in terms of changes in the HRV slope over the 10-day time-course.ResultsFirstly, for the acute phase we found increased HRV during the daily practice sessions in both the mindfulness and active-control group indicating that both interventions were effective in decreasing acute physiological stress. Secondly, for the chronic phase we found increased HRV in both the day- and nighttime indicating increased sleep quality, specifically in the mindfulness group.ConclusionThese results suggest causal effects in both chronic and acute phases of mindfulness practice in formerly naïve subjects and provides support for the argument that brief online-based mindfulness interventions exert positive impact on HRV.
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Project description:BackgroundCardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined.ObjectiveThe aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery.MethodsA double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ≥18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ≥4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board.ResultsRecruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic.ConclusionsThis research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain.International registered report identifier (irrid)DERR1-10.2196/30951.
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Project description:BackgroundUniversity students are experiencing higher levels of distress and mental health disorders than before. In addressing mental health needs, web-based interventions have shown increasing promise in overcoming geographic distances and high student-to-counselor ratios, leading to the potential for wider implementation. The Mindfulness Virtual Community (MVC) program, a web-based program, guided by mindfulness and cognitive behavioral therapy principles, is among efforts aimed at effectively and efficiently reducing symptoms of depression, anxiety, and perceived stress in students.ObjectiveThis study's aim was to evaluate the efficacy of an 8-week MVC program in reducing depression, anxiety, and perceived stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a large Canadian university. Guided by two prior randomized controlled trials (RCTs) that each demonstrated efficacy when conducted during regular university operations, this study coincided with a university-wide labor strike. Nonetheless, the students' response to an online mental health program on a disrupted campus can provide useful information for anticipating the impact of other disruptions, including those related to the COVID-19 pandemic as well as future disruptions.MethodsIn this parallel-arm RCT, 154 students were randomly allocated to an 8-week MVC intervention (n=76) or a wait-list control (WLC) condition (n=78). The MVC intervention included the following: (1) educational and mindfulness video modules, (2) anonymous peer-to-peer discussions, and (3) anonymous, group-based, professionally guided, 20-minute videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using the following: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR (1) covariance structure were used to evaluate the impact of the intervention, with outcome evaluations performed on both an intention-to-treat (ITT) and per-protocol (PP) basis.ResultsParticipants (n=154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between the MVC and WLC groups on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the two groups. Results under both ITT and PP approaches indicated that there were no statistically significant between-group differences in PHQ-9 (ITT: β=-0.44, P=.64; PP: β=-0.62, P=.053), BAI (ITT: β=-2.06, P=.31; PP: β=-2.32, P=.27), and FFMQ-SF (ITT: β=1.33, P=.43; PP: β=1.44, P=.41) compared to WLC. There was a significant difference for the PSS (ITT: β=-2.31, P=.03; PP: β=-2.38, P=.03).ConclusionsDuring a university labor strike, the MVC program led to statistically significant reductions in PSS compared to the WLC group, but there were no other significant between-group differences. Comparisons with previous cycles of intervention testing, undertaken during nondisrupted university operations, when efficacy was demonstrated, are discussed.Trial registrationISRCTN Registry ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275.
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Project description:ObjectiveTo assess the efficacy of Bounce Back Now (BBN), a modular, Web-based intervention for disaster-affected adolescents and their parents.MethodA population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and several areas in Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study Web portal irrespective of mental health status at baseline. Families who accessed the Web portal were assigned randomly to 1 of 3 groups: BBN, which featured modules for adolescents and parents targeting adolescents' mental health symptoms; BBN plus additional modules targeting parents' mental health symptoms; or assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression.ResultsNearly 50% of families accessed the Web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B = -0.24, SE = 0.08, p < .01) and depressive symptoms (B = -0.23, SE = 0.09, p < .01). Post hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental versus control conditions at 12-month follow-up (PTSD: B = -0.36, SE = 0.19, p = .06; depressive symptoms: B = -0.42, SE = 0.19, p = 0.03). A time × condition interaction also was found that favored the BBN versus BBN + parent self-help condition for PTSD symptoms (B = 0.30, SE = 0.12, p = .02) but not depressive symptoms (B = 0.12, SE = 0.12, p = .33).ConclusionResults supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters.Clinical trial registration informationWeb-based Intervention for Disaster-Affected Youth and Families; http://clinicaltrials.gov; NCT01606514.
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Project description:BackgroundOne of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs).Methods/designThe primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability.DiscussionIn this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain.Trial registrationClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.
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Project description:Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations.This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project. In spite of possible limitations, this project will be one among very few aimed at improving quality of life, sleep, and mood in adolescents living with cancer, will evaluate the potential benefits of such a practice on both psychological and physical health of youth with cancer, and help in creating mindfulness-based intervention programs, in order to provide the necessary psychological help to adolescents living with cancer.NCT01783418.
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Project description:BackgroundPsychological distress is a common occurrence among women during the perinatal period. Maternal psychological distress (MPS) can also have a negative influence on neonatal outcomes such as infant health, child development or mother-child interaction. Hence, interventions to improve mental wellbeing during this period are vital. Mindfulness based intervention (MBI) has been found to be effective in reducing psychological distress. Delivery of MBI via the internet, making it accessible and inexpensive, is showing a promising positive effect in reducing psychological distress. A randomized control trial with sufficient power is required to confirm its positive effect among pregnant women. The positive effects of MBI have been found to be associated with heart rate variability (HRV) biofeedback; however, the efficacy of MBI on HRV has been rarely studied among pregnant women. Also, the potential association of HRV with MBI and psychological wellbeing needs further examination. This research aims to test the effectiveness of guided mobile-based perinatal mindfulness intervention (GMBPMI) among pregnant women experiencing psychological distress during the pre- and post-natal period, as well as examining the efficacy of GMBPMI on HRV.MethodThis study is a randomized controlled trial that follows a parallel design. Consenting pregnant women in their second trimester (between 12th and 20th week gestation) will be randomly assigned to an intervention group (GMBPMI) or a control group (psychoeducation). The intended sample size is 198, with 99 participants in each group. Three levels of outcomes will be measured at baseline, post intervention in both the intervention and control groups, and at 36-week gestation and five-week postpartum. The primary outcomes include maternal psychological stress, mindfulness and positive appraisal HRV. Secondary outcomes are psychological and physical wellbeing. Tertiary outcomes include obstetric and neonatal outcomes, and social support. Analyses will follow an intention-to-treat method and repeated measures MANOVA will be conducted to compare changes in primary and secondary outcomes. A series of mixed-effects models will be fitted to assess the mediation effects.DiscussionThis trial expects to increase understanding of GMBPMI on HRV and psychological wellbeing for pregnant women, with extended support in both pre-and post-natal periods. The study could also potentially provide evidence for delivery of cost-effective and accessible services to pregnant women.Trial registrationClinicalTrials.gov: NCT04876014, registered on 30 March 2021. Protocol Version 1.0., 10 May 2021.
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