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Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study.

ABSTRACT: Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined the effectiveness of MBSR in partners of cancer patients. Therefore, in the present trial we study the effectiveness of MBSR versus treatment as usual (TAU) in patients with lung cancer and their partners.A parallel group, randomized controlled trial is conducted to compare MBSR with TAU. Lung cancer patients who have received or are still under treatment, and their partners are recruited. Assessments will take place at baseline, post intervention and at three-month follow-up. The primary outcome is psychological distress (i.e. anxiety and depressive symptoms). Secondary outcomes are quality of life (only for patients), caregiver appraisal (only for partners), relationship quality and spirituality. In addition, cost-effectiveness ratio (only in patients) and several process variables are assessed.This trial will provide information about the clinical and cost-effectiveness of MBSR compared to TAU in patients with lung cancer and their partners.

SUBMITTER: Schellekens MP

PROVIDER: S-EPMC3893473 | biostudies-literature | 2014 Jan

REPOSITORIES: biostudies-literature

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Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study.

Schellekens Melanie P J MP van den Hurk Desiree G M DG Prins Judith B JB Molema Johan J Donders A Rogier T AR Woertman Willem H WH van der Drift Miep A MA Speckens Anne E M AE

BMC cancer 20140103

<h4>Background</h4>Lung cancer is the leading cause of cancer death worldwide and characterized by a poor prognosis. It has a major impact on the psychological wellbeing of patients and their partners. Recently, it has been shown that Mindfulness-Based Stress Reduction (MBSR) is effective in reducing anxiety and depressive symptoms in cancer patients. The generalization of these results is limited since most participants were female patients with breast cancer. Moreover, only one study examined ...[more]

PMID: 24386906

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Project description:BackgroundMindfulness-based interventions have shown to reduce psychological distress in cancer patients. The accessibility of mindfulness-based interventions for cancer patients could be further improved by providing mindfulness using an individual internet-based format. The aim of this study is to test the effectiveness of a Mindfulness-Based Cognitive Therapy (MBCT) group intervention for cancer patients in comparison with individual internet-based MBCT and treatment as usual (TAU).Methods/designA three-armed multicenter randomized controlled trial comparing group-based MBCT to individual internet-based MBCT and TAU in cancer patients who suffer from at least mild psychological distress (Hospital Anxiety and Depression Scale (HADS) ≥ 11). Measurements will be conducted prior to randomization (baseline), post-treatment and at 3 months and 9 months post-treatment. Participants initially allocated to TAU are subsequently randomized to either group- or individual internet-based MBCT and will receive a second baseline measurement after 3 months. Thus, the three-armed comparison will have a time span of approximately 3 months. The two-armed intervention comparison includes a 9-month follow-up and will also consist of participants randomized to the intervention after TAU. Primary outcome will be post-treatment psychological distress (HADS). Secondary outcomes are fear of cancer recurrence (Fear of Cancer Recurrence Inventory), rumination (Rumination and Reflection Questionnaire), positive mental health (Mental Health Continuum - Short Form), and cost-effectiveness (health-related quality of life (EuroQol -5D and Short Form-12) and health care usage (Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness). Potential predictors: DSM-IV-TR mood/anxiety disorders (SCID-I) and neuroticism (NEO-Five Factor Inventory) will be measured. Mediators of treatment effect: mindfulness skills, (Five-Facets of Mindfulness Questionnaire- Short Form), working alliance (Working Alliance Inventory) and group cohesion (Group Cohesion Questionnaire) will also be measured.DiscussionThis trial will provide valuable information on the clinical and cost-effectiveness of group versus internet-based MBCT versus TAU for distressed cancer patients.Trial registrationClinicaltrials.gov NCT02138513. Registered 6 May 2014.

Project description:Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.A randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T1), immediately following the intervention (T2), and at 3 months postpartum (T3). Descriptive statistics will be used to describe sample characteristics. Data will be analyzed using an intention-to-treat approach. Hierarchical linear models will be used to test intervention effects on primary and secondary outcomes.The trial is expected to improve knowledge about evidence-based treatments for psychological distress experienced in pregnancy and to evaluate the potential impact of mindfulness-based interventions on maternal physiology.ClinicalTrials.gov: NCT02214732 , registered on 7 August 2014. Protocol Version 2.0., 5 September 2016.

Project description:IntroductionAlthough a high percentage of patients with cancer experience severe psychological distress, few of them receive psycho-oncological care, largely due to barriers on the side of patients and healthcare providers that pose great challenges to delivering such care. In response, low-threshold, self-guided eHealth interventions can enable patients with cancer to deal independently and effectively with disease-related challenges and distress. Mindfulness and Skills-Based Distress Reduction in Oncology Training, nicknamed Make It Training, is one such innovative, self-guided eHealth intervention. In our study, we propose to assess different characteristics of such patients in order to define target populations for Make It Training, evaluate the intervention in terms of its usability, feasibility and sustainability and gather longitudinal data concerning the intervention's efficacy.Methods and analysisSelf-guided and web-based Make It Training consists of eight 30 min modules involving the use of techniques of mindfulness therapy, cognitive-behavioural therapy and acceptance and commitment therapy to be completed in a 4-month period. In our observational study, adult patients with cancer who possess adequate German language skills and provide their informed consent will be recruited at Essen, Erlangen and Tübingen University Hospitals at outpatient oncological institutions and via online channels. Patients will undergo a baseline online assessment (T0), an assessment directly after completing the intervention (T1) and assessments 3 and 6 months later (T2 and T3, respectively). With the results of those assessments, we will perform descriptive analyses of their sociodemographic and medical data, compare means and conduct regression analyses.Ethics and disseminationThe Ethics Committees of the University Hospitals Essen, Erlangen and Tübingen have approved the study (19-8643-BO, 27_19 B, 293/2018BO1). Results will be published in peer-reviewed journals and conference presentations.Trial registration numberDRKS00017119.

Project description:BackgroundSelf-control in childhood has been linked to long-term and cascading effects on health, academic, criminality, wealth and parenting outcomes. Hence it is important to target self-control deficits early in life. Self-control deficits are a hallmark of Attention Deficit/Hyperactivity Disorder (ADHD). Even after receiving care-as-usual (CAU) for ADHD, impaired self-control often remains. Pharmacotherapy can be hampered by side-effects, low adherence and short-term effectiveness. Other limitations of CAU are decreased effectiveness when parents have ADHD and little effect on parental well-being. Mindfulness-Based Interventions (MBIs) are an emerging non-pharmacological approach with potential to improve self-control and well-being in both children and parents. However, there is a lack of sufficiently powered randomised controlled trials (RCTs) to establish their effects in families with ADHD. This study protocol describes an RCT to investigate the effectiveness of a family MBI as an add-on to CAU in treatment of youth with ADHD, and is described in accordance with Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT).Methods/designAn RCT will be conducted in N = 100 children (aged 8-16 years) with ADHD and their parents. The experimental condition will consist of a family MBI (MYmind): 8-week group-based MBI for youth combined with parallel group-based Mindful Parenting for their parents, as an add-on to CAU. The control condition will consist of CAU-only. Assessments will take place at baseline, end of treatment (3 months later), 2 and 6 months' follow-up. Primary outcome measure will be an ecologically valid assessment of child self-control with the parent-rated Behaviour Rating Inventory of Executive Function (BRIEF). Secondary child outcome measures will be teacher-rated BRIEF, computerised self-control tasks and questionnaires on psychological symptoms (e.g. ADHD, symptoms of autism), well-being and mindfulness. For parental outcomes, secondary measures will be self-rated BRIEF, computerised self-control tasks and questionnaires on psychological symptoms, well-being and mindful parenting.DiscussionThe proposed RCT will take account of methodological limitations of previous studies on MBIs in child ADHD populations. The current study will provide valuable information on family MBI as a potential effective intervention in targeting self-control deficits for youth with ADHD and their parents.Trial registrationClinicalTrials.gov NCT03220308 . Retrospectively registered 18 July 2017.

Project description:BackgroundThe COVID-19 pandemic has dramatically affected mental health, creating an urgent need for convenient and safe interventions to improve well-being. Online mindfulness interventions show promise for improving depression, anxiety, and general well-being.ObjectiveTo assess: 1) the impact of online mindfulness on psychological distress, 2) altruistic efforts, and 3) the quantity, quality, and availability of online mindfulness resources during the COVID-19 pandemic.Methods233 participants (203 U.S.; 20 international; 10 unknown) participated in this prospective, single-arm, non-randomized clinical trial of a single online mindfulness meditation session with pre- and post-surveys.Main outcome measures(a) Mindfulness session helpfulness, online platform effectiveness, and immediate pre- to post-session changes in momentary stress, anxiety, and COVID-19 concern; (b) qualitative themes representing how people are helping others during the pandemic; (c) absolute changes in quantity of mindfulness-oriented web content and free online mindfulness resource availability from May to August 2020.ResultsMost participants felt the online mindfulness session was helpful and the electronic platform effective for practicing mindfulness (89%, 95% CI: [82 to 93%]), with decreased momentary anxiety (76%; 95% CI: [69 to 83%]), stress (80%; [72 to 86%]), and COVID-19 concern (55%; [46 to 63%]), (p < 0.001 for each measure). Participants reported helping others in a variety of ways during the pandemic, including following public health guidelines, conducting acts of service and connection, and helping oneself in hopes of helping others. "Mindfulness + COVID" search results increased by 52% from May to August 2020. Most (73%) Academic Consortium for Integrative Medicine and Health member websites offer free online mindfulness resources.ConclusionsVirtual mindfulness is an increasingly accessible intervention available world-wide that may reduce psychological distress during this isolating public health crisis. Kindness and altruism are being demonstrated during the pandemic. The consolidated online mindfulness resources provided may help guide clinicians and patients.

Dataset Information

Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study.

Publications

Study protocol of a randomized controlled trial comparing Mindfulness-Based Stress Reduction with treatment as usual in reducing psychological distress in patients with lung cancer and their partners: the MILON study.

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