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Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer.

ABSTRACT: The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT). There is also a need for RCTs investigating the efficacy of psychosocial interventions on mood disorder and immune response in women with breast cancer. Therefore, the overall aim is to determine the efficacy of a Mindfulness Based Stress Reduction (MBSR) intervention on well-being and immune response in women with breast cancer.In this RCT, patients diagnosed with breast cancer, will consecutively be recruited to participate. Participants will be randomized into one of three groups: MBSR Intervention I (weekly group sessions + self-instructing program), MBSR Intervention II (self-instructing program), and Controls (non-MBSR). Data will be collected before start of intervention, and 3, 6, and 12 months and thereafter yearly up to 5 years. This study may contribute to evidence-based knowledge concerning the efficacy of MBSR to support patient empowerment to regain health in breast cancer disease.The present study may contribute to evidence-based knowledge concerning the efficacy of mindfulness training to support patient empowerment to regain health in a breast cancer disease. If MBSR is effective for symptom relief and quality of life, the method will have significant clinical relevance that may generate standard of care for patients with breast cancer.ClinicalTrials.gov: NCT01591915.

SUBMITTER: Kenne Sarenmalm E

PROVIDER: S-EPMC3850932 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

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Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer.

Kenne Sarenmalm Elisabeth E Mårtensson Lena B LB Holmberg Stig B SB Andersson Bengt A BA Odén Anders A Bergh Ingrid I

BMC complementary and alternative medicine 20131002

<h4>Background</h4>The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT). There is also a need for RCTs investigating the efficacy of psychosocial interve ...[more]

PMID: 24088535

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Project description:BACKGROUND:Psychological distress during pregnancy is common: up to 20% of the childbearing women experience symptoms of depression and anxiety. Apart from the adverse effects on the woman herself, pregnancy distress can negatively affect pregnancy outcomes, infant health, postpartum mother-child interaction and child development. Therefore, the development of interventions that reduce pregnancy distress is very important. Mindfulness-based interventions (MBIs) show promising positive effects on pregnancy distress, but there is a need for randomized controlled trials with sufficient power. Trials on online MBIs, which are readily accessible and not expensive, also show positive effects on stress reduction in non-pregnant populations. Moreover, specific working mechanisms of MBIs remain unclear. The aim of the current study is to test the effectiveness of an online MBI in pregnant women with pregnancy distress, as well as exploring potential working mechanisms. METHODS:The current study is a randomized controlled trial with repeated measures. Consenting women with elevated levels of pregnancy distress will be randomized into an intervention group (MBI) or control group (care as usual) around 12?weeks of pregnancy, with an intended sample size of 103 women in each group. The primary outcome, pregnancy distress, will be assessed via questionnaires at baseline, halfway through the intervention and post intervention in both intervention and control group, and after 8 weeks follow-up in the intervention group. Secondary outcomes are mindfulness skills, rumination and self-compassion, which are also seen as potential working mechanisms, and will be assessed via questionnaires before intervention, halfway through the intervention, post intervention and after 8 weeks follow-up in the intervention group. Tertiary outcome variables are obstetric data and will be collected from the obstetric records for both intervention and control group. Analyses will be based on the intention-to-treat principle. Multilevel regression models for repeated measures (mixed models) will be used to evaluate changes in primary and secondary outcome variables. Tertiary outcomes will be compared between groups using independent t-tests and Chi Square analyses. DISCUSSION:The trial is expected to increase knowledge about the effectiveness of online MBIs during pregnancy in women with pregnancy distress and to evaluate potential working mechanisms. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03917745, registered on 4 March 2019. Protocol Version 3.0., 20 February 2020.

Project description:BACKGROUND:Burnout is highly prevalent in residents. No randomized controlled trials have been conducted measuring the effects of Mindfulness-Based Stress Reduction (MBSR) on burnout in residents. OBJECTIVE:To determine the effectiveness of MBSR in reducing burnout in residents. DESIGN:A randomized controlled trial comparing MBSR with a waitlist control group. PARTICIPANTS:Residents from all medical, surgical and primary care disciplines were eligible to participate. Participants were self-referred. INTERVENTION:The MBSR consisted of eight weekly 2.5-h sessions and one 6-h silent day. MAIN MEASURES:The primary outcome was the emotional exhaustion subscale of the Dutch version of the Maslach Burnout Inventory-Human Service Survey. Secondary outcomes included the depersonalization and reduced personal accomplishment subscales of burnout, worry, work-home interference, mindfulness skills, self-compassion, positive mental health, empathy and medical errors. Assessment took place at baseline and post-intervention approximately 3 months later. KEY RESULTS:Of the 148 residents participating, 138 (93%) completed the post-intervention assessment. No significant difference in emotional exhaustion was found between the two groups. However, the MBSR group reported significantly greater improvements than the control group in personal accomplishment (p = 0.028, d = 0.24), worry (p = 0.036, d = 0.23), mindfulness skills (p = 0.010, d = 0.33), self-compassion (p = 0.010, d = 0.35) and perspective-taking (empathy) (p = 0.025, d = 0.33). No effects were found for the other measures. Exploratory moderation analysis showed that the intervention outcome was moderated by baseline severity of emotional exhaustion; those with greater emotional exhaustion did seem to benefit. CONCLUSIONS:The results of our primary outcome analysis did not support the effectiveness of MBSR for reducing emotional exhaustion in residents. However, residents with high baseline levels of emotional exhaustion did appear to benefit from MBSR. Furthermore, they demonstrated modest improvements in personal accomplishment, worry, mindfulness skills, self-compassion and perspective-taking. More research is needed to confirm these results.

Project description:ObjectiveCombining 3rd-wave-therapies with Cognitive-Behavioural-Therapy (CBT) has increased in recent years. Usually these therapies require longer sessions which therefore increases the psychotherapy drop-out rate for cancer patients for multiple medical reasons. This inspired intervention of a shorter 20 min-long mindfulness-therapy (MBST) to be developed for Breast-Cancer-patients (BC).MethodThis pilot randomised controlled trial was to assess the immediate-outcome of the MBST-intervention for its efficacy for BC-patients by using the Pearson Chi-square test, Fisher-Freeman-Halton exact test, and McNemar test for categorical variables; Mann-Whitney U and Wilcoxon test for the continuous variables. The Emotion Thermometer, State Trait Anxiety Inventory, Hospital Anxiety and Depression Scale, Self-Efficacy for Managing Chronic Disease, and Beck's Hopelessness Scale were used for measuring the intervention outcomes. One hundred seventy-three BC patients were randomly assigned in two-groups (equal-mean-age, p = 0.417). Control-Group (CG, n = 82) received cognitive-disputation-technique a form-of-CBT, and Intervention-Group (IG, n = 74) received MBST. The directives are given to IG: psychoeducation about Mindfulness, and to imagine themselves swinging-in a peaceful environment. When the patients imagine their swing going up, they physically take a deep-breath, and when going down they physically release their breath, and this process is repeated.ResultOutcomes post-treatment showed significant higher-improvement in IG in all the assessed-measurements, with large-effect-size: anxiety (p < 0,05, r = 0,67) and depression-levels (p < 0,05, r = 0,71); anxiety-trait (p < 0,05; r = 0,79) reduced, it increases self-efficacy for managing-disease (p < 0,05, r = 0,82) as-well-as hopefulness (p < 0,05, r = 0,61) and saturation-level measured by pulse-meter/oximeter (p < 0,05, r = 0,51).ConclusionMBST is an efficacious intervention to reduce psychotherapy session time for immediate relief from clinical anxiety and hopelessness as well as increase self-efficacy and improve tranquillity for BC-women. It may have a particular clinical significance for supporting patient's adherence to treatment. Although in this pilot sample MBST was found to be effective for short-term-outcome, its efficacy for longer-term-outcome should be examined in future trials. Additionally, breathing laps can be increased possibly for a greater result on rise of saturation levels of patients.

Project description:ObjectiveEvidence links depression and stress to more rapid progression of HIV-1 disease. We conducted a randomized controlled trial to test whether an intervention aimed at improving stress management and emotion regulation, mindfulness-based stress reduction (MBSR), would improve immunological (i.e. CD4+ T-cell counts) and psychological outcomes in persons with HIV-1 infection.MethodsWe randomly assigned participants with HIV-1 infection and CD4 T-cell counts >350 cells/μl who were not on antiretroviral therapy in a 1:1 ratio to either an MBSR group (n = 89) or an HIV disease self-management skills group (n = 88). The study was conducted at the University of California at San Francisco. We assessed immunologic (CD4, c-reactive protein, IL-6, and d-dimer) and psychological measures (Beck Depression Inventory for depression, modified Differential Emotions Scale for positive and negative affect, Perceived stress-scale, and mindfulness) at 3, 6 and 12 months after initiation of the intervention; we used multiple imputation to address missing values.ResultsWe observed statistically significant improvements from baseline to 3-months within the MBSR group in depression, positive and negative affect, perceived stress, and mindfulness; between group differences in change were significantly greater in the MBSR group only for positive affect (per item difference on DES-positive 0.25, 95% CI 0.049, 0.44, p = .015). By 12 months the between group difference in positive affect was not statistically significant, although both groups had trends toward improvements compared to baseline in several psychological outcomes that were maintained at 12-months; these improvements were only statistically significant for depression and negative affect in the MBSR group and perceived stress for the control group. The groups did not differ significantly on rates of antiretroviral therapy initiation (MBSR = 39%, control = 29%, p = .22). After 12 months, the mean decrease in CD4+ T-cell count was 49.6 cells/μl in participants in the MBSR arm, compared to 54.2 cells/μl in the control group, a difference of 4.6 cells favoring the MBSR group (95% CI, -44.6, 53.7, p = .85). The between group differences in other immunologic-related outcomes (c-reactive protein, IL-6, HIV-1 viral load, and d-dimer) were not statistically significant at any time point.ConclusionsMBSR improved positive affect more than an active control arm in the 3 months following the start of the intervention. However, this difference was not maintained over the 12-month follow-up and there were no significant differences in immunologic outcomes between intervention groups. These results emphasize the need for further carefully designed research if we are to translate evidence linking psychological states to immunological outcomes into evidence-based clinical practices.

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Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer.

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Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer.

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