Clinical trial NCT02138513: (Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients
Official title: (Cost-) Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) in Cancer Patients: a Superiority Trial of Online and Face-to-face Treatment Versus Treatment as Usual (TAU).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress
Anxiety
Depression
Keywords: Mindfulness
MBCT
Cancer
Oncology
E-health
Cost-effectiveness
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. As this intervention can be offered in groups, costs are relatively low. In addition, delivering MBCT online might make the intervention more accessible and cost-effectiveness. However, more information is needed about what treatment works best for which patient.

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.


Eligibility criteria: Inclusion Criteria:

* HADS ≥ 11
* 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:

* severe psychiatric morbidity as psychoses, suicidal ideation
* previous mindfulness-based treatment.

Primary outcomes:
measure: Change from baseline in anxiety and depressive symptoms
timeFrame: 0 (baseline), 3 months (post intervention)
Secondary outcomes:
measure: Change from baseline in fear of cancer recurrence
timeFrame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
measure: DSM-IV Axis I mood or anxiety disorders
timeFrame: 0, 3 (post intervention), 12 months (9mo follow-up)
measure: Change from baseline in positive mental health
timeFrame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
measure: Change from baseline in healthcare consumption
timeFrame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
measure: Change from baseline in health-related quality of life
timeFrame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
measure: Change from baseline in health-related quality of life
timeFrame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
measure: Change from baseline in mindfulness skills
timeFrame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
measure: Change from baseline in rumination
timeFrame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
measure: Change from baseline in personality assessment
timeFrame: 0 (baseline) and 12 months (9mo follow-up)
measure: Change in mindfulness skills during intervention
timeFrame: week 2,3,4,5,6,7,8 and 9 of intervention
measure: Group cohesion during intervention
timeFrame: week 4 and week 9 during intervention
measure: Working alliance during intervention
timeFrame: week 4 and week 9 during intervention
measure: Change in mood during intervention
timeFrame: week 2,3,4,5,6,7,8 and 9 of intervention
measure: Change from baseline in anxiety and depressive symptoms - follow up
timeFrame: 0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre for Mindfulness, Radboud University Nijmegen Medical Centre
state: Gelderland
city: Bilthoven
country: Netherlands
facility: Helen Dowling Institute
state: Utrecht
Study officials:
affiliation: Radboud University Medical Centre Nijmegen
name: Anne EM Speckens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.