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.
Nasim Badaghi, Mette van Kruijsbergen, Judith Prins, Saskia Kelders, Linda Cillessen, Felix R. Compen, Rogier Donders, Linda Kwakkenbos, Anne E. M. Speckens
BMC Psychology January 25, 2023 DOI: 10.1186/s40359-023-01052-2 (opens in new tab)
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Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Population | Dutch-speaking adult cancer patients or survivors with access to the internet |
| Interventions | Blended therapist-assisted eMBCT unguided individual eMBCT care as usual |
| Duration | Outcome measures evaluated at baseline, mid-treatment, immediately post-treatment, and three-, six-, and nine-months follow-up |
| Measures | Hospital Anxiety and Depression Scale, FCRI, CIS-F, RRQ, FFMQ, EQ, SCS-SF, MHCSF, EQ-5D, TiC-P, TWEETS |
| Topics | Meditation |
| Keywords | Blended therapy Cancer E-health Internet-based interventions Psycho-oncology Randomized controlled trial Unguided therapy |
| Registration | NCT05336916 |
| Key findings | The trial is designed to evaluate whether blended and unguided eMBCT reduce psychological distress and improve quality of life compared with care as usual in cancer patients and survivors. The authors propose these formats may be easily accessible and could address barriers such as lack of peer support and asynchronicity that affect adherence and drop-out. |
Abstract
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. 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. 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 .
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 3
- Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial (Preprint) August 31, 2023
- Long-Term Outcomes, Moderators, and Predictors in Online Mindfulness-Based Cognitive Therapy for People With Cancer: Secondary Analysis of a Randomized Controlled Trial. Journal of Medical Internet Research April 17, 2026
- Randomized Controlled Trial of Group-Blended and Individual-Unguided Online Mindfulness-Based Cognitive Therapy to Reduce Psychological Distress in People With Cancer. Psycho-Oncology September 1, 2025
Cites 9
- The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials Perspectives on Psychological Science February 16, 2021
- Mindfulness‐based interventions for psychological and physical health outcomes in cancer patients and survivors: A systematic review and meta‐analysis of randomized controlled trials Psycho-Oncology September 11, 2019
- Web-based individual Mindfulness-Based Cognitive Therapy for cancer-related fatigue — A pilot study Internet Interventions April 6, 2015
- Mindfulness-based cognitive therapy for depression. Industrial Psychiatry Journal October 29, 2024
- 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. Journal of Clinical Oncology June 28, 2018
and 4 more in the library