Clinical trial · Interventional
Effectiveness of Blended and Unguided Delivery of Mindfulness-based Cognitive Therapy for Cancer Patients
(Cost)Effectiveness of Blended and UnguideD DeliverY of Mindfulness-based Cognitive Therapy Versus Care as Usual for Cancer Patients: BUDDY Project
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Rationale: Approximately one in three cancer patients and survivors experience significant psychological distress. Previous research has shown that mindfulness-based interventions such as mindfulness-based cognitive therapy (MBCT) can help reduce distress among cancer patients. However, MBCT typically takes place in face-to-face group sessions, which are not easily accessible to many cancer patients. Blended therapist-assisted (combination of group sessions and individual online sessions) and unguided online MBCT interventions may address this problem, however, research on effectiveness of these interventions is missing. Objective: This three-armed, randomized controlled trial (RCT) evaluates the effectiveness and cost-effectiveness of blended therapist-assisted (blended MBCT) and unguided individual internet-based MBCT (online MBCT) compared to treatment-as-usual (TAU) for cancer patients. Secondly, consolidation of treatment effects is studied up to nine months post-treatment. Thirdly, possible working mechanisms and effect moderators are studied. Study design: The current study is a RCT with three arms (blended MBCT, online MBCT and TAU) with assessments at baseline (T0), mid-treatment, post-treatment (T1) and 3 months follow-up (T2). At 3 months follow-up (T2), patients in the TAU arm will be crossed over to blended MBCT or online MBCT (random allocation). Uncontrolled follow-up assessments will be conducted at 6 (T3) and 9 months (T4) follow-up. Study population: 254 adults (\>18 years) who have or have had a cancer diagnosis (any stage/any type) will be randomized. Intervention: Patients will be randomly assigned with a 1:1:1 ratio to one of three groups: (1) blended MBCT: patients will be invited to a blended therapist-assisted MBCT program, consisting of 8 weekly sessions (4 online group meetings, 4 online sessions with therapist assistance, and an online silent day), in addition to TAU; (2) online MBCT: patients will be invited to an individual internet-based MBCT program without assistance from a therapist, that consists of 8 weekly sessions and a silent day, in addition to TAU; (3) TAU: patients receive usual care, which can be medical, psychological or paramedical care, except mindfulness interventions. Main study parameters/endpoints: Primary outcome is the difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the blended MCBT and TAU arms and between the online MCBT and TAU arms post-treatment (T1).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Buddy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Blended MBCT
- description
- The blended MBCT consists of four 2,5 hour group sessions through videoconference (session 1, 3, 5 and 8), taught by experienced mindfulness trainers. The other sessions (2, 4, 6 and 7) are delivered online and are individual. Mindfulness trainers will provide online feedback to participants for these sessions. The sessions include meditation exercises, psycho-education, and group discussion. In addition to the sessions, participants are instructed to do daily home practice 45 minutes a day. The regular MBCT program was adapted to fit the needs of the target group and, for instance includes psycho-education about grief and cancer-related fatigue. Online sessions were built around a specific theme. Participants are provided with information, audio files of meditations, and recording assignments around the theme of the session through a personal, secure webpage. The sessions look appealing and persuasive technologies such as reminders and videos are used.
- interventionNames
- Behavioral: Buddy
- type
- EXPERIMENTAL
- label
- Unguided online MBCT
- description
- Participants in the unguided online arm receive access to the 8 online mindfulness sessions (same intervention as blended MBCT arm), but no mindfulness trainer will be involved. Each online session was built around a specific theme, for instance automatic pilot, communication or self-care. Participants are provided with information, audio files of meditations, and recording assignments around the theme of the session through a personal, secure webpage. Participants are encouraged to read the information and do the assigned meditations and recording assignments within one week. The sessions will look appealing and persuasive technologies such as reminders and video's will be used.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. A cancer diagnosis, any tumor or stage 2. Computer literacy and internet access 3. Good command of the Dutch language 4. Willingness to participate in either MBCT intervention Exclusion Criteria: 1. Previous participation in MBSR or MBCT (\>4 sessions) 2. Severe psychiatric comorbidity that warrants acute treatment (psychosis, mania, severe personality disorders, suicidal thoughts) 3. Alcohol or drug dependence 4. Severe cognitive impairments
References
Publications (3)
- DERIVEDBadaghi N, Kwakkenbos L, Prins J, Donders R, Kelders S, Speckens A. Randomized Controlled Trial of Group-Blended and Individual-Unguided Online Mindfulness-Based Cognitive Therapy to Reduce Psychological Distress in People With Cancer. Psychooncology. 2025 Sep;34(9):e70286. doi: 10.1002/pon.70286. PMID 40968786
- DERIVEDBadaghi N, van Kruijsbergen M, Speckens A, Vile J, Prins J, Kelders S, Kwakkenbos L. Group, Blended and Individual, Unguided Online Delivery of Mindfulness-Based Cognitive Therapy for People With Cancer: Feasibility Uncontrolled Trial. JMIR Form Res. 2024 Feb 21;8:e52338. doi: 10.2196/52338. PMID 38381493
- DERIVEDBadaghi N, van Kruijsbergen M, Prins J, Kelders S, Cillessen L, Compen F, Donders R, Kwakkenbos L, Speckens A. 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 Psychol. 2023 Jan 25;11(1):21. doi: 10.1186/s40359-023-01052-2. PMID 36698197