Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial
Abstract Background One third of cancer patients and survivors experience psychological distress. Previous studies have shown that online mindfulness-based cognitive therapy (eMBCT) supports cancer patients and survivors in managing distress. Lack of peer support and asynchronicity during online int...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-01-01
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| Series: | BMC Psychology |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s40359-023-01052-2 |
| _version_ | 1797863225627246592 |
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| author | Nasim Badaghi Mette van Kruijsbergen Judith Prins Saskia Kelders Linda Cillessen Félix Compen Rogier Donders Linda Kwakkenbos Anne Speckens |
| author_facet | Nasim Badaghi Mette van Kruijsbergen Judith Prins Saskia Kelders Linda Cillessen Félix Compen Rogier Donders Linda Kwakkenbos Anne Speckens |
| author_sort | Nasim Badaghi |
| collection | DOAJ |
| description | Abstract Background One third of cancer patients and survivors experience psychological distress. Previous studies have shown that online mindfulness-based cognitive therapy (eMBCT) supports cancer patients and survivors in managing distress. Lack of peer support and asynchronicity during online interventions have been reported as barriers for treatment adherence and can result in higher drop-out rates. Considering this, two new formats of eMBCT were created. The primary objective of the Buddy trial is to evaluate the (cost) effectiveness of blended and unguided eMBCT versus care as usual (CAU) on psychological distress among cancer patients and survivors. Secondary objectives include evaluating effects on other psychological outcomes and investigating working mechanisms and treatment effect moderators. Methods The Buddy trial is a parallel three-armed randomized controlled trial. Participants will be randomly assigned to blended therapist-assisted eMBCT, unguided individual eMBCT or CAU. Eligible participants will be Dutch-speaking adult cancer patients or survivors with access to internet. The primary outcome will be psychological distress scores as assessed by the Hospital Anxiety and Depression scale immediately post-treatment. Secondary outcome measures include fear of cancer recurrence (FCRI), fatigue (CIS-F), rumination (RRQ), mindfulness skills (FFMQ), decentering (EQ), self-compassion (SCS-SF), positive mental health (MHCSF), health related quality of life (EQ-5D), and costs associated with psychiatric illness (TiC-P). Outcome measures will be evaluated at baseline, mid-treatment, immediately post-treatment, and three-, six-, and nine-months follow-up. Possible mediators, such as engagement with interventions (TWEETS), and moderators will be also analyzed. Discussion There is room to improve eMBCT for cancer patients prior to implementation to ensure adherence and scalability. Blended and unguided eMBCT may reduce psychological distress and improve quality of life and be easily accessible to cancer patients and survivors. Trial registration clinicaltrials.gov, NCT05336916, registered on April 20th, 2022. https://clinicaltrials.gov/ct2/show/NCT05336916 . |
| first_indexed | 2024-04-09T22:32:09Z |
| format | Article |
| id | doaj.art-cfa3720dacbb45fb9bc89d3e426c7fbc |
| institution | Directory Open Access Journal |
| issn | 2050-7283 |
| language | English |
| last_indexed | 2024-04-09T22:32:09Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychology |
| spelling | doaj.art-cfa3720dacbb45fb9bc89d3e426c7fbc2023-03-22T12:42:27ZengBMCBMC Psychology2050-72832023-01-0111111310.1186/s40359-023-01052-2Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trialNasim Badaghi0Mette van Kruijsbergen1Judith Prins2Saskia Kelders3Linda Cillessen4Félix Compen5Rogier Donders6Linda Kwakkenbos7Anne Speckens8Department of Psychiatry, Radboud University Medical CenterDepartment of Psychiatry, Radboud University Medical CenterDepartment of Medical Psychology, Radboud University Medical CenterDepartment of Psychology, Health, and Technology, University of TwenteDepartment of Psychiatry, Radboud University Medical CenterDepartment of Psychiatry, Radboud University Medical CenterRadboud Institute for Health Evidence, Radboud University Medical CenterDepartment of Psychiatry, Radboud University Medical CenterDepartment of Psychiatry, Radboud University Medical CenterAbstract Background One third of cancer patients and survivors experience psychological distress. Previous studies have shown that online mindfulness-based cognitive therapy (eMBCT) supports cancer patients and survivors in managing distress. Lack of peer support and asynchronicity during online interventions have been reported as barriers for treatment adherence and can result in higher drop-out rates. Considering this, two new formats of eMBCT were created. The primary objective of the Buddy trial is to evaluate the (cost) effectiveness of blended and unguided eMBCT versus care as usual (CAU) on psychological distress among cancer patients and survivors. Secondary objectives include evaluating effects on other psychological outcomes and investigating working mechanisms and treatment effect moderators. Methods The Buddy trial is a parallel three-armed randomized controlled trial. Participants will be randomly assigned to blended therapist-assisted eMBCT, unguided individual eMBCT or CAU. Eligible participants will be Dutch-speaking adult cancer patients or survivors with access to internet. The primary outcome will be psychological distress scores as assessed by the Hospital Anxiety and Depression scale immediately post-treatment. Secondary outcome measures include fear of cancer recurrence (FCRI), fatigue (CIS-F), rumination (RRQ), mindfulness skills (FFMQ), decentering (EQ), self-compassion (SCS-SF), positive mental health (MHCSF), health related quality of life (EQ-5D), and costs associated with psychiatric illness (TiC-P). Outcome measures will be evaluated at baseline, mid-treatment, immediately post-treatment, and three-, six-, and nine-months follow-up. Possible mediators, such as engagement with interventions (TWEETS), and moderators will be also analyzed. Discussion There is room to improve eMBCT for cancer patients prior to implementation to ensure adherence and scalability. Blended and unguided eMBCT may reduce psychological distress and improve quality of life and be easily accessible to cancer patients and survivors. Trial registration clinicaltrials.gov, NCT05336916, registered on April 20th, 2022. https://clinicaltrials.gov/ct2/show/NCT05336916 .https://doi.org/10.1186/s40359-023-01052-2Internet-based interventionsMindfulness based cognitive behavioral-therapyRandomized controlled trialE-healthCancerPsycho-oncology |
| spellingShingle | Nasim Badaghi Mette van Kruijsbergen Judith Prins Saskia Kelders Linda Cillessen Félix Compen Rogier Donders Linda Kwakkenbos Anne Speckens Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial BMC Psychology Internet-based interventions Mindfulness based cognitive behavioral-therapy Randomized controlled trial E-health Cancer Psycho-oncology |
| title | Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial |
| title_full | Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial |
| title_fullStr | Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial |
| title_full_unstemmed | Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial |
| title_short | Effect of blended and unguided online delivery of mindfulness-based cognitive therapy versus care as usual on distress among cancer patients and survivors: protocol for the three-arm parallel randomized controlled buddy trial |
| title_sort | effect of blended and unguided online delivery of mindfulness based cognitive therapy versus care as usual on distress among cancer patients and survivors protocol for the three arm parallel randomized controlled buddy trial |
| topic | Internet-based interventions Mindfulness based cognitive behavioral-therapy Randomized controlled trial E-health Cancer Psycho-oncology |
| url | https://doi.org/10.1186/s40359-023-01052-2 |
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