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BMC Psychiatry
Published in: BMC Psychiatry 1/2019

Open Access 01-12-2019 | Study protocol

Study protocol of a multicenter randomized controlled trial of mindfulness-based cognitive therapy and treatment as usual in bipolar disorder

Authors: I. Hanssen, M. J. Huijbers, M. W. H. Lochmann-van Bennekom, E. J. Regeer, A. W. M. M. Stevens, S. M. A. A. Evers, M. Wensing, R. W. Kupka, A. E. M. Speckens

Published in: BMC Psychiatry | Issue 1/2019

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Abstract

Background

Despite multiple pharmacological interventions, many people with bipolar disorder (BD) experience substantial residual mood symptoms, even in the absence of severe mood episodes, which have a negative impact on the course of illness and quality of life. Limited data are available on how to optimize treatment for BD, especially for those who suffer from persistent and residual depressive symptoms. Preliminary evidence suggests Mindfulness-Based Cognitive Therapy (MBCT) as a psychological treatment option for BD. This study aims to investigate whether adding MBCT to treatment as usual (TAU) will result in symptomatic and functional improvements in adults with BD compared to TAU alone.

Methods/design

This study is a prospective, evaluator blinded, multicenter, randomized controlled trial of MBCT + TAU and TAU alone in 160 adults with bipolar type I and type II. Assessments will be conducted at baseline (T0), mid-treatment (Tmid), and at 3 (T1), 6 (T2), 9 (T3), 12 (T4), and 15 (T5) months follow-up. Primary outcome is post-treatment severity of depressive symptoms (Inventory of Depressive Symptomatology- Clinician administered). Secondary outcomes are severity of (hypo) manic symptoms, anxiety, relapse rates, overall functioning, positive mental health, and cost-effectiveness. As possible mediators will be assessed rumination of negative affect, dampening and rumination of positive affect, mindfulness skills, and self-compassion.

Discussion

This study will provide valuable insight into the (cost-)effectiveness of MBCT on clinician- and self-rated symptoms of BD, relapse rates, positive mental health, and overall functioning.

Trial registration

NCT03507647. Registered 25th of April 2018.
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Metadata
Title
Study protocol of a multicenter randomized controlled trial of mindfulness-based cognitive therapy and treatment as usual in bipolar disorder
Authors
I. Hanssen
M. J. Huijbers
M. W. H. Lochmann-van Bennekom
E. J. Regeer
A. W. M. M. Stevens
S. M. A. A. Evers
M. Wensing
R. W. Kupka
A. E. M. Speckens
Publication date
01-12-2019
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2019
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-019-2115-6

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