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Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study.

ABSTRACT: Mindfulness-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).A 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.This trial will provide valuable information on the clinical and cost-effectiveness of group versus internet-based MBCT versus TAU for distressed cancer patients.Clinicaltrials.gov NCT02138513. Registered 6 May 2014.

SUBMITTER: Compen FR

PROVIDER: S-EPMC4535375 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study.

Compen F R FR Bisseling E M EM Van der Lee M L ML Adang E M M EM Donders A R T AR Speckens A E M AE

BMC psychology 20150813

<h4>Background</h4>Mindfulness-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).< ...[more]

PMID: 26273472

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Project description:BackgroundPsychological distress is prevalent among university students. However, the availability of evidence-based mental health treatment remains limited in many low- and middle-income countries, including Indonesia. Internet-delivered, mindfulness-based interventions that reduce distress have potential for treating university student distress at scale. Unfortunately, evidence-based, internet-delivered mindfulness treatments are not yet available in Indonesia. Cultural adaptation of established evidence-based, internet-delivered mindfulness interventions is needed.ObjectiveIn this paper, we describe the process of culturally adapting an Australian internet-delivered mindfulness program (Introduction to Mindfulness) to be relevant and appropriate for treating Indonesian university students' psychological distress.MethodsTo assist the cultural adaptation process, we used a systematic cultural adaptation framework and a mixed methods approach combining quantitative and qualitative methods. In study 1 (information gathering), we administered an internet-delivered questionnaire to Indonesian university students (n=248) to examine their preferences regarding an internet-delivered mindfulness intervention. In study 2 (preliminary design), a draft program was developed and independently reviewed by Indonesian stakeholders. Stakeholders (n=25) included local Indonesian mindfulness and mental health professionals (n=6) and university students (n=19), who were selected to maximize sample representativeness regarding personal and professional characteristics. To evaluate the initial design and cultural congruence of the internet-delivered mindfulness program in the Indonesian context, we conducted interviews and focus groups with stakeholders. Stakeholders also completed the Cultural Relevance Questionnaire.ResultsIn study 1, most Indonesian university students (240/248, 96.8%) reported openness to an internet-delivered mindfulness program. Most of interested students (127/240, 52.9%) preferred the length of the program to be 3 to 4 sessions, with 45.8% (110/240) preferring brief lessons taking only 15 to 30 minutes to complete. They (194/240, 80.8%) recommended that the program be accessible both through websites and mobile phones. In study 2, Indonesian stakeholders generally found the internet-delivered program to be highly culturally appropriate in terms of language, concepts, context, treatment goals, and depictions of students' emotional and behavioral experiences. However, stakeholders also recommended some specific adaptations regarding the program's delivery model (eg, combining visual and audio modalities when delivering psychoeducation), cultural components (eg, including more social and spiritual activities), program practicality (eg, including rewards to promote engagement), and design elements (eg, including additional culturally relevant illustrations). Following stakeholder feedback, a new culturally adapted Indonesian internet-delivered mindfulness program called Program Intervensi Mindfulness Daring Mahasiswa Indonesia was created.ConclusionsThis study highlights the process and importance of cultural adaptation of an evidence-based mindfulness treatment and demonstrates how this may be achieved for internet-delivered psychotherapy programs. We found that a culturally adapted internet-delivered mindfulness program was relevant for Indonesian students with some adjustments to the programs' content and delivery. Future research is now needed to evaluate the clinical benefit of this program.

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:BackgroundMindfulness-based interventions (MBIs) have been used in oncology contexts as a promising tool with numerous benefits for various health-related and psychosocial outcomes. Despite the increasing popularity of MBIs, few randomized controlled trials (RCTs) have examined their effects upon biological parameters. Specifically, no previous study has examined the effects of MBIs on extracellular vesicles (EVs), which are potentially important markers of health, disease, and stress. Moreover, the lack of RCTs is even more limited within the context of technology-mediated MBIs and long-term effects.MethodsThe current study protocol presents a two-arm, parallel, randomized controlled study investigating the effects of internet-supported mindfulness-based cognitive therapy (MBCT) compared with treatment as usual (TAU). Primary outcomes are psychological distress and EV cargo of distressed participants with previous breast, colorectal, or prostate cancer diagnoses. Secondary outcomes are self-reported psychosocial and health-related measures, and additional biological markers. Outcomes will be assessed at baseline, 4 weeks after baseline (mid-point of the intervention), 8 weeks after baseline (immediately post-intervention), 24 weeks after baseline (after booster sessions), and 52 weeks after baseline. Our goal is to recruit at least 111 participants who have been diagnosed with breast, prostate, or colorectal cancer (cancer stage I to III), are between 18 and 65 years old, and have had primary cancer treatments completed between 3 months and 5 years ago. Half of the participants will be randomized to the TAU group, and the other half will participate in an 8-week online MBCT intervention with weekly group sessions via videoconference. The intervention also includes asynchronous homework, an online retreat after the fifth week, and 4 monthly booster sessions after completion of the 8-week programme.DiscussionThis study will allow characterizing the effects of internet-based MBCT on psychosocial and biological indicators in the context of cancer. The effects on circulating EVs will also be investigated, as a possible neurobiological pathway underlying mind-body intervention effects.Trial registrationClinicalTrials.gov NCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).

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 multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study.

Publications

Study protocol of a multicenter randomized controlled trial comparing the effectiveness of group and individual internet-based Mindfulness-Based Cognitive Therapy with treatment as usual in reducing psychological distress in cancer patients: the BeMind study.

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