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

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, 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

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.

Keywords: Bipolar disorder; Mindfulness-based cognitive therapy; Randomized controlled trial; study protocol.

Conflict of interest statement

Ethics approval and consent to participate

The study protocol has been approved by the ethical review board CMO Arnhem – Nijmegen and is registered under number NL63319.091.17. Both verbal and written consent to participate will be obtained.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of study procedures from referral to final assessment

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