Mindfulness Based Cognitive Therapy for Bipolar Disorder

NCT03507647 | Completed DMC

• 1 other identifier: MBCT-BD-2017-2021
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

randomized controlled trial; Mindfulness based cognitive therapy; clinical effectiveness; cost-effectiveness; working mechanisms

Outcome Measures

Primary Outcomes (1)

• Inventory of Depressive Symptomatology

  A clinican-administered interview assessing the severity of depressive symptoms

  Change between baseline and 3 months

Secondary Outcomes (19)

• Structured Clinical Interview for DSM-IV-TR Disorders

  Change between baseline and 15 months

• Young Mania Rating Scale

  Change between baseline and 3 months

• Young Mania Rating Scale

  Change between baseline and 15 months

• Functioning Assessment Short Test

  Change between baseline and 3 months

• Functioning Assessment Short Test

  Change between baseline and 15 months

Other Outcomes (12)

• Euro-Quality of Life 5D-5L

  baseline

• Euro-Quality of Life 5D-5L

  3 months

• Euro-Quality of Life 5D-5L

  6 months

Study Arms (2)

Mindfulness Based Cognitive Therapy added to usual care

EXPERIMENTAL

Patients in the MBCT arm will be invited to participate in MBCT added to their usual care.

Behavioral: Mindfulness Based Cognitive Therapy; Other: Usual Care

Usual Care

ACTIVE COMPARATOR

Usual care will typically consist of pharmacotherapy, psycho-education and self-management interventions (usually with a psychiatric nurse).

Other: Usual Care

Interventions

Mindfulness Based Cognitive Therapy BEHAVIORAL

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.

Also known as: MBCT, Mindfulness training

Mindfulness Based Cognitive Therapy added to usual care

Usual Care OTHER

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.

Mindfulness Based Cognitive Therapy added to usual care; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• bipolar I or II disorder
• having suffered at least two lifetime depressive episodes, either current or in (partial) remission at baseline (according to SCID assessment)
• Young Mania Rating Scale score \< 8

You may not qualify if:

• a manic episode in the 3 months before the start of the trial
• lifetime diagnosis of schizophrenia or schizoaffective disorder, current substance abuse disorder, organic brain syndrome, antisocial or borderline personality disorder
• risk of suicide or aggression
• the presence of a concurrent significant medical condition impeding the ability to participate
• currently receiving regular psychological therapy
• previous participation in a MBCT or MBSR course

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Pro Persona Mental Health Care Foundation: collaborator
• Altrecht: collaborator
• Dimence: collaborator
• PsyQ: collaborator

Study Sites (4)

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Dimence GGZ

Deventer, Netherlands

Location

Pro Persona

Nijmegen, Netherlands

Location

Altrecht GGZ

Utrecht, Netherlands

Location

Related Publications (4)

• Hanssen I, Huijbers M, Regeer E, Lochmann van Bennekom M, Stevens A, van Dijk P, Boere E, Havermans R, Hoenders R, Kupka R, Speckens AE. Mindfulness-based cognitive therapy v. treatment as usual in people with bipolar disorder: A multicentre, randomised controlled trial. Psychol Med. 2023 Oct;53(14):6678-6690. doi: 10.1017/S0033291723000090. Epub 2023 Mar 7.

  PMID: 39625263 DERIVED

• Hanssen I, Scheepbouwer V, Huijbers M, Regeer E, Lochmann van Bennekom M, Kupka R, Speckens A. Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. PLoS One. 2021 Nov 4;16(11):e0259167. doi: 10.1371/journal.pone.0259167. eCollection 2021.

  PMID: 34735517 DERIVED

• Hanssen I, van der Horst N, Boele M, Lochmann van Bennekom M, Regeer E, Speckens A. The feasibility of mindfulness-based cognitive therapy for people with bipolar disorder: a qualitative study. Int J Bipolar Disord. 2020 Nov 11;8(1):33. doi: 10.1186/s40345-020-00197-y.

  PMID: 33175338 DERIVED

• Hanssen I, Huijbers MJ, Lochmann-van Bennekom MWH, Regeer EJ, Stevens AWMM, Evers SMAA, Wensing M, Kupka RW, Speckens AEM. Study protocol of a multicenter randomized controlled trial of mindfulness-based cognitive therapy and treatment as usual in bipolar disorder. BMC Psychiatry. 2019 Apr 30;19(1):130. doi: 10.1186/s12888-019-2115-6.

  PMID: 31039765 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anne Speckens, Prof.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by independent research assistants blind to condition. Participants will be instructed to avoid unblinding as much as possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Randomized, multicenter, prospective, evaluator-blinded clinical trial of MBCT added to treatment as usual (TAU) versus TAU alone

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: April 25, 2018
• Study Start: April 23, 2018
• Primary Completion: June 16, 2020
• Study Completion: June 17, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

NL (4)