(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients (BeMind)
2017年9月18日 更新者：Radboud University Medical Center
(Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).
Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.
Therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual MBCT online and MBCT offered as a group training compared to TAU .
Study design: The design of the study will be a multi-centre, randomised, superiority trial, comparing MBCT online and MBCT offered as a group training with TAU. Participants in the TAU condition will be randomised to one of the treatment conditions after 3 months. Main assessments will take place at baseline (T0), post-treatment (T1), and 3 (T2) and 9 months after post-treatment (T3).
We expect the MBCT conditions to be superior to TAU in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. We also expect the MBCT to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than TAU.
研究概览
研究类型
介入性
注册 (实际的)
245
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Gelderland
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Nijmegen、Gelderland、荷兰、6500HB
- Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
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Utrecht
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Bilthoven、Utrecht、荷兰、3723 MB
- Helen Dowling Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- HADS ≥ 11
- Cancer diagnosis (at present or past)
- Stable dose if using psychopharmacological medication for at least 3 months
- computer literacy and acces to internet
- capable of filling out questionnaires in Dutch
Exclusion Criteria:
- severe psychiatric morbidity as psychoses, suicidal ideation
- previous mindfulness-based treatment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Online MBCT
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This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice.
Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week.
They will receive files with meditation and yoga exercises to support this.
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实验性的：group MBCT
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This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice.
Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week.
They will receive files with meditation and yoga exercises to support this.
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无干预：Treatment as usual
3 months waiting list, subsequent assignment to group or online MBCT
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change from baseline in anxiety and depressive symptoms
大体时间：0 (baseline), 3 months (post intervention)
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Anxiety and depressive symptoms as assessed by the Hospital Anxiety and Depression-scale (HADS).
The HADS is a self-report questionnaire that comprises 14 items measuring feelings of generalized fear and depressive symptoms.
The HADS is considered a reliable and valid instrument for assessing anxiety and depression in medical patients and is sensitive to change (Herrmann, 1997; Bjelland et al., 2002).
This instrument was also validated in a palliative cancer population (Akechi, 2006).
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0 (baseline), 3 months (post intervention)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in fear of cancer recurrence
大体时间：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Fear of cancer recurrence will be assessed with the Fear of Cancer Recurrence Inventory (FCRI; Simard & Savard, 2009a; van der Lee et al., 2012).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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DSM-IV Axis I mood or anxiety disorders
大体时间：0, 3 (post intervention), 12 months (9mo follow-up)
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DSM IV Axis I psychiatric disorder as diagnosed by a structured interview
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0, 3 (post intervention), 12 months (9mo follow-up)
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Change from baseline in positive mental health
大体时间：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The Mental Health Continuum-Short Form (MHC-SF) measures positive mental health and comprises 14 items, representing various feelings of well-being.
Respondents rate the frequency of every feeling in the past month on a 6-point Likert scale (never, once or twice a month, about once a week, two or three times a week, almost every day, every day).
The MHC-SF contains three subscales: emotional, psychological and social well-being.
MHC-SF has shown high internal and moderate test-retest reliability, convergent and discriminant validity.
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in healthcare consumption
大体时间：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The TIC-P generates quantitative data about direct medical costs and indirect societal costs as a consequence of psychological/psychiatric illnesses.
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in health-related quality of life
大体时间：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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To measure the quality of the health status of cancer patients a validated health-related quality of life (HRQoL) instrument will be used, the EuroQol-5D (EQ-5D).
This HRQoL instrument will be completed by the patient together with a researcher and is available in a validated Dutch translation (Lamers, 2005).
The EQ-5D is a generic HRQoL instrument comprising five domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The EQ-5D index is obtained by applying predetermined weights to the five domains.
This index gives a societal-based global quantification of the participant's health status on a scale ranging from 0 (death) to 1 (perfect health).
Participants will also be asked to rate their overall HRQoL on a visual analogue scale (EQ- 5D VAS) consisting of a vertical line ranging from 0 (worst imaginable health status) to 100 (best imaginable).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in health-related quality of life
大体时间：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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In addition to the EQ-5D, the SF-12 will be administered for explorative purposes for there are indications that the SF-12 is more sensitive for changes in HRQol in populations with less severe morbidity (Johnson and Coons, 1998).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in mindfulness skills
大体时间：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The 39-item Five Facet Mindfulness Questionnaire has been developed as a reliable and valid comprehensive instrument for assessing different aspects of mindfulness.
A Dutch 24-item short form of the FFMQ (FFMQ-SF) was developed and assessed in a sample of 376 adults with clinically relevant symptoms of depression and anxiety and cross-validated in an independent sample of patients with fibromyalgia.
Confirmatory factor analyses showed good model fit for the five-factor structure of the FFMQ-SF: observing, describing, acting with awareness, nonjudging, and nonreactivity.
The FFMQ-SF was related to measures of psychological symptoms, well-being, experiential avoidance, and the personality factors neuroticism and openness to experience.
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in rumination
大体时间：0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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The rumination subscale of the RRQ assesses a neurotic self-attentiveness (i.e.
recurrent, primarily past-oriented thinking about the self), which is prompted by threats, losses, of injustices to the self.
Subjects rate their level of agreement of disagreement on a five-point rating scale (e.g., "I always seem to be rehashing in my mind recent things I've said or done").
There is evidence of good internal consistency (.90) and stability over a 10-month period and convergent validity.
The measure in the current study was translated into Dutch using the guidelines of the International Test Commission (Hambleton, 1994).
Cronbach's alphas were .88 and .90 in Sample 1, and .90 and .91 in Sample 2, respectively (Luyckx et al., 2008).
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0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
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Change from baseline in personality assessment
大体时间：0 (baseline) and 12 months (9mo follow-up)
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Personality is measured with the NEO Five Factor Inventory (NEO-FFI, Costa & McCrae, 1992) which consists of five domains: neuroticism, extraversion, openness, altruism, and conscientiousness.
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0 (baseline) and 12 months (9mo follow-up)
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Change in mindfulness skills during intervention
大体时间：week 2,3,4,5,6,7,8 and 9 of intervention
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The Mindful Attention Awareness Scale (MAAS) will be administered before each MBCT session to assess mindful attention in daily life
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week 2,3,4,5,6,7,8 and 9 of intervention
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Group cohesion during intervention
大体时间：week 4 and week 9 during intervention
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We will examine self-reported individual group cohesion ratings during the MBCT training with a Dutch Group Cohesion Questionnaire that has been used in cancer patients before (May et al., 2008).
The GCQ-23 uses 22 items across four scales: the bond with the group as whole, the bond with other members, cooperation within the group and the instrumental value.
Each item is rated from 1 (totally disagree) to 6 (totally agree).
Internal consistency of all scales was reported to range from adequate to good (0.66-0.88).
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week 4 and week 9 during intervention
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Working alliance during intervention
大体时间：week 4 and week 9 during intervention
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The Working Alliance Inventory (WAI) is most often used to assess working alliance between participant and healthcare professional.
We will use the Dutch translation of the short form (WAI-S, Vervaeke & Vertommen, 1996), which is closely related to the original scale and also has good psychometric and predictive quality (Busseri & Tyler, 2003).
The WAI-S is a 12 item, self report questionnaire, rated on a 7-point Likert scale (1 = never to 7 = always) with three subscales: 1) agreement between participant and therapist on the goals of the therapy; 2) agreement on the rationale of the therapy addressing the problems of the participant; and 3) the quality of the interpersonal bond between the participant and the therapist.
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week 4 and week 9 during intervention
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Change in mood during intervention
大体时间：week 2,3,4,5,6,7,8 and 9 of intervention
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In the current study, positive and negative affect is assessed before each MBCT session using the International Positive and Negative Affect Scale - Short Form.
The cross-sample stability, internal reliability, temporal stability, crosscultural factorial invariance, and convergent and criterion-related validities of the I-PANAS-SF were examined and found to be psychometrically acceptable (Thompson, 2007).
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week 2,3,4,5,6,7,8 and 9 of intervention
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Change from baseline in anxiety and depressive symptoms - follow up
大体时间：0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
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Hospital Anxiety and Depression Scale - anxiety and depressive symptoms at follow up.
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0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Anne EM Speckens, MD, PhD、Radboud University Medical Centre Nijmegen
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bisseling EM, Compen FR, Schellekens MPJ, Thewes B, Speckens AEM, van der Lee ML. Exploring Fear of Cancer Recurrence in a Sample of Heterogeneous Distressed Cancer Patients with and Without a Psychiatric Disorder. J Clin Psychol Med Settings. 2021 Sep;28(3):419-426. doi: 10.1007/s10880-021-09776-2. Epub 2021 Jun 17.
- Bisseling E, Cillessen L, Spinhoven P, Schellekens M, Compen F, van der Lee M, Speckens A. Development of the Therapeutic Alliance and its Association With Internet-Based Mindfulness-Based Cognitive Therapy for Distressed Cancer Patients: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Med Internet Res. 2019 Oct 18;21(10):e14065. doi: 10.2196/14065.
- Compen F, Bisseling E, Schellekens M, Donders R, Carlson L, van der Lee M, Speckens A. Face-to-Face and Internet-Based Mindfulness-Based Cognitive Therapy Compared With Treatment as Usual in Reducing Psychological Distress in Patients With Cancer: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2018 Aug 10;36(23):2413-2421. doi: 10.1200/JCO.2017.76.5669. Epub 2018 Jun 28.
- Compen FR, Bisseling EM, Van der Lee ML, Adang EM, Donders AR, Speckens AE. 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. BMC Psychol. 2015 Aug 13;3(1):27. doi: 10.1186/s40359-015-0084-1. eCollection 2015.
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年4月1日
初级完成 (实际的)
2016年7月20日
研究完成 (实际的)
2017年5月1日
研究注册日期
首次提交
2014年5月6日
首先提交符合 QC 标准的
2014年5月12日
首次发布 (估计)
2014年5月14日
研究记录更新
最后更新发布 (实际的)
2017年9月19日
上次提交的符合 QC 标准的更新
2017年9月18日
最后验证
2016年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.