(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients
NCT ID: NCT02138513
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
245 participants
INTERVENTIONAL
2014-04-30
2017-05-01
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Online MBCT
Mindfulness Based Cognitive Therapy
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.
group MBCT
Mindfulness Based Cognitive Therapy
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.
Treatment as usual
3 months waiting list, subsequent assignment to group or online MBCT
No interventions assigned to this group
Interventions
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Mindfulness Based Cognitive Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* previous mindfulness-based treatment.
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Anne EM Speckens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Centre Nijmegen
Locations
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Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Helen Dowling Institute
Bilthoven, Utrecht, Netherlands
Countries
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References
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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.
Other Identifiers
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NL46338.091.13
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012.WO14.C153
Identifier Type: -
Identifier Source: org_study_id