(Cost-)Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Cancer Patients (BeMind)

Radboud University Medical Center

Status: Completed

Conditions: Distress; Depression; Anxiety

Treatments: Behavioral: Mindfulness Based Cognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02138513

2012.WO14.C153

NL46338.091.13 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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245 participants in 3 patient groups

Online MBCT

Experimental group

Treatment:

Behavioral: Mindfulness Based Cognitive Therapy

group MBCT

Experimental group

Treatment:

Behavioral: Mindfulness Based Cognitive Therapy

Treatment as usual

No Intervention group

Description:

3 months waiting list, subsequent assignment to group or online MBCT