Overview

This trial is active, not recruiting.

Conditions distress, anxiety, depression
Treatment mindfulness based cognitive therapy
Sponsor Radboud University
Start date April 2014
End date September 2016
Trial size 245 participants
Trial identifier NCT02138513, 2012.WO14.C153, NL46338.091.13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
mindfulness based cognitive therapy
This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
(Experimental)
mindfulness based cognitive therapy
This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
(No Intervention)
3 months waiting list, subsequent assignment to group or online MBCT

Primary Outcomes

Measure
Change from baseline in anxiety and depressive symptoms
time frame: 0 (baseline), 3 months (post intervention)

Secondary Outcomes

Measure
Change from baseline in fear of cancer recurrence
time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
DSM-IV Axis I mood or anxiety disorders
time frame: 0, 3 (post intervention), 12 months (9mo follow-up)
Change from baseline in positive mental health
time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in healthcare consumption
time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in health-related quality of life
time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in mindfulness skills
time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in rumination
time frame: 0, 3 (post intervention), 6 (3mo follow-up) and 12 months (9mo follow-up)
Change from baseline in personality assessment
time frame: 0 (baseline) and 12 months (9mo follow-up)
Change in mindfulness skills during intervention
time frame: week 2,3,4,5,6,7,8 and 9 of intervention
Group cohesion during intervention
time frame: week 4 and week 9 during intervention
Working alliance during intervention
time frame: week 4 and week 9 during intervention
Change in mood during intervention
time frame: week 2,3,4,5,6,7,8 and 9 of intervention
Change from baseline in anxiety and depressive symptoms - follow up
time frame: 0, (baseline) 6 (3mo follow-up) and 12 months (9mo follow-up)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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).
Principal investigator Anne EM Speckens, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Radboud University.