Mindfulness Based Cognitive Therapy for Bipolar Disorder

Summary

The current study will be a randomized controlled trial (RCT) investigating the clinical and cost-effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) as an adjunct to usual care, versus usual care alone, in reducing depressive symptoms in patients with bipolar disorder. Outcome measures include depressive, (hypo)manic and anxiety symptoms, risk of relapse/recurrence, functioning and mental health/well-being. The study also aims to explore possible working mechanisms such as improvements of mindfulness and self-compassion skills. The study will have a follow-up duration of 15 months from baseline.

Conditions

• Bipolar Disorder

Interventions

BEHAVIORAL

Mindfulness Based Cognitive Therapy

MBCT is a manualised group skills-training program (Segal, Williams \& Teasdale 2012) consisting of eight weekly sessions of 2.5 hours, plus one day of silent practice. The program includes both formal and informal meditation exercises. Cognitive techniques that are part of the program are education, monitoring and scheduling of activities, identification of negative automatic thoughts and devising a relapse prevention plan. The MBCT treatment will be adapted to address the needs of patients with a bipolar disorder. A few examples of these adaptations are: (more) psychoeducation about manic symptoms in addition to the psychoeduction about depression; introducing the 3-minute breathing space earlier in the programme and more often during sessions, especially when strong emotions are present; repeatedly bringing the focus to self-care; and making use of the mindful movement (yoga) exercises more frequently.

OTHER

Usual Care

Usual care will typically consist of pharmacotherapy, psycho-education and self-management interventions (usually with a psychiatric nurse). Usual care will not be restricted, except for proscribing high-frequency psychological interventions such as (group) cognitive behavioral therapy, for practical and methodological reasons.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Pro Persona Mental Health Care Foundation

  collaborator OTHER

• Altrecht

  collaborator OTHER

• Dimence

  collaborator UNKNOWN

• PsyQ

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Principal Investigators

• Anne Speckens, Prof. · Radboud University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-23

Primary Completion

2020-06-16

Completion

2021-06-17

Countries

• Netherlands

Study Locations