Effectiveness of Blended and Unguided Delivery of Mindfulness-based Cognitive Therapy for Cancer Patients
BUDDY
(Cost)Effectiveness of Blended and UnguideD DeliverY of Mindfulness-based Cognitive Therapy Versus Care as Usual for Cancer Patients: BUDDY Project
1 other identifier
interventional
254
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Jan 2021
Typical duration for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedMay 13, 2022
March 1, 2022
1.9 years
March 23, 2022
May 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
The HADS is a 14-item questionnaire measuring distress. Items are scored on a 0-3 scale that are summed to obtain a distress total score (range 0-42). Higher scores represent more distress.
1 week post-treatment
Secondary Outcomes (11)
Difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
3, 6 and 9 months post-treatment
Difference in Fear of Cancer Recurrence Inventory (FCRI) severity subscale scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Checklist Individual Strength (CIS)- Fatigue scores between patients in the Blended MBCT arm and TAU, and between Online MBCT arm and TAU
1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Rumination and Reflection Questionnaire (RRQ) rumination subscales scores between patients in the Blended MBCT arm and TAU, and between Online MBCT arm and TAU
1 week post-treatment and 3, 6 and 12 months post-treatment
Difference in Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) scores between patients in the Blended MBCT arm and TAU, and between patients in the Online MBCT arm and TAU
1 week post-treatment and 3, 6 and 12 months post-treatment
- +6 more secondary outcomes
Study Arms (3)
Blended MBCT
EXPERIMENTALThe 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.
Unguided online MBCT
EXPERIMENTALParticipants 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.
Treatment As Usual
NO INTERVENTIONNot offered the mindfulness program, treatment as usual
Interventions
Eligibility Criteria
You may qualify if:
- A cancer diagnosis, any tumor or stage
- Computer literacy and internet access
- Good command of the Dutch language
- Willingness to participate in either MBCT intervention
You may not qualify if:
- Previous participation in MBSR or MBCT (\>4 sessions)
- Severe psychiatric comorbidity that warrants acute treatment (psychosis, mania, severe personality disorders, suicidal thoughts)
- Alcohol or drug dependence
- Severe cognitive impairments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Dutch Cancer Societycollaborator
Study Sites (1)
Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
Related Publications (3)
Badaghi 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: 40968786DERIVEDBadaghi 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: 38381493DERIVEDBadaghi 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: 36698197DERIVED
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2022
First Posted
April 20, 2022
Study Start
January 20, 2021
Primary Completion
January 1, 2023
Study Completion
July 1, 2023
Last Updated
May 13, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 12 months after the collection of the primary outcome
- Access Criteria
- Approval of proposed purpose for data access
Upon request