Mindfulness Based Cognitive Therapy for Bipolar Disorder (MBCT-BD)

• ClinicalTrials.gov Identifier: NCT03507647
• Recruitment Status: Active, not recruiting
• First Posted: April 25, 2018
• Last Update Posted: October 29, 2021
• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Pro Persona; Altrecht; Dimence; PsyQ
• Information provided by (Responsible Party): Anne Speckens, Radboud University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder	Behavioral: Mindfulness Based Cognitive Therapy; Other: Usual Care	Not Applicable

Detailed Description:

Introduction:

In the Netherlands, the lifetime prevalence of bipolar disorder (BD) is about 1.2% for men and 1.4% for women (de Graaf et al 2010). BD usually manifests itself during late adolescence or early adulthood. Its course is often chronic, with patients suffering from recurrent depressive, (hypo)manic, or mixed episodes, being symptomatic about half of the time (Judd 2002). Although hospital admissions are more common during manic episodes, illness-related disability is more strongly influenced by depressive episodes (Judd 2003). It has been estimated that about 25-50% of the patients with BD attempts suicide at least once and that the risk of suicide is about 5%(Hawton 2005).

Depressive symptoms in BD are common and have been associated with negative effects on the course of bipolar disorder in terms of functional impairment and quality of life (Gutiérrez-Rojas 2008). There are limited data on how to optimize the treatment of persistent or residual depressive symptoms in BD or to improve outcomes for those patients who do not benefit sufficiently from the available treatments. In addition, there is a need for interventions that not only target symptom reduction but also help patients to cope with their illness from a wider perspective, i.e. in terms of their personal values, goals, and social roles.

Mindfulness-Based Cognitive Therapy (MBCT) is an innovative intervention that has been shown effective in reducing depressive symptoms in unipolar recurrent depression (Aalderen 2012, Kuyken 2016) and appears promising for coping with severe mental illness (Davis and Kurzban 2012). Little is known about the effectiveness of MBCT for BD, with a number of pilot studies showing reductions in depressive symptoms, and one RCT showing reduction of anxiety symptoms. Considering the need for additional psychosocial treatments that not only target symptomatic but also personal recovery, these preliminary but encouraging findings warrant a larger RCT examining the efficacy of MBCT for BD in the Netherlands.

Aims:

As there are limited data on how to improve outcomes for those patients who do not benefit sufficiently from the available treatments, this study aims to compare MBCT to TAU as an adjunctive treatment to reduce depressive symptoms in patients with bipolar disorder. Outcomes of MBCT for BD patients will be examined both on a symptom level (depression, mania, anxiety, risk of relapse/recurrence) and in terms of functioning and mental health/well-being, including its possible working mechanisms such as improvements of mindfulness and self-compassion skills.

Method:

A randomized, multicenter, prospective, evaluator-blinded clinical trial of MBCT added to treatment as usual (TAU) versus TAU alone. Assessments will be conducted at baseline and at 3, 6, 9, 12 and 15 months follow-up.

The intervention will consist of usual care, and for half of the participants MBCT will be offered in adjunct. MBCT is a manualised group skills-training program (Segal, Williams & Teasdale 2012) designed as a relapse prevention programme for patients with recurrent depression. The training consists 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 based on the 8-week MBCT course developed by Segal, Williams and Teasdale (2012), but 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 psychoeducation 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. All group sessions will be conducted at the respective mental health centres, with each group comprising 8-12 participants. MBCT courses will be taught by experienced and qualified mindfulness teachers, together with a health care professional specialised in the care for BD patients. Teacher competency will be assessed with the Mindfulness-Based Interventions - Teaching Assessment Criteria (Crane et al 2013), for which all trial sessions will be videotaped.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, multicenter, prospective, evaluator-blinded clinical trial of MBCT added to treatment as usual (TAU) versus TAU alone
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcomes will be assessed by independent research assistants blind to condition. Participants will be instructed to avoid unblinding as much as possible.
• Primary Purpose: Treatment
• Official Title: Mindfulness Based Cognitive Therapy for Bipolar Disorder
• Actual Study Start Date: April 23, 2018
• Actual Primary Completion Date: February 16, 2020
• Estimated Study Completion Date: November 17, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mindfulness Based Cognitive Therapy added to usual care; Patients in the MBCT arm will be invited to participate in MBCT added to their usual care.	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 Names: MBCT; Mindfulness training; 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.
Active Comparator: Usual Care; Usual care will typically consist of pharmacotherapy, psycho-education and self-management interventions (usually with a psychiatric nurse).	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.

Outcome Measures

Primary Outcome Measures :

1. Inventory of Depressive Symptomatology [ Time Frame: Change between baseline and 3 months ]
   A clinican-administered interview assessing the severity of depressive symptoms

Secondary Outcome Measures :

1. Structured Clinical Interview for DSM-IV-TR Disorders [ Time Frame: Change between baseline and 15 months ]
   Diagnostic instrument to assess relapse of depressive or (hypo)manic episode
2. Young Mania Rating Scale [ Time Frame: Change between baseline and 3 months ]
   Young Mania Rating Scale (YMRS) Dutch translation. The YMRS is an 11-item clinician-administered rating scale to assess the severity of (hypo)manic symptoms. It was found to be a reliable, valid, and sensitive rating scale to measure the severity of mania (Young et al., 1978). Its total score ranges from 0 (no (hypo)manic symptoms) to 44 (severe manic symptoms).
3. Young Mania Rating Scale [ Time Frame: Change between baseline and 15 months ]
   Young Mania Rating Scale (YMRS) Dutch translation. The YMRS is an 11-item clinician-administered rating scale to assess the severity of (hypo)manic symptoms. It was found to be a reliable, valid, and sensitive rating scale to measure the severity of mania (Young et al., 1978). Its total score ranges from 0 (no (hypo)manic symptoms) to 44 (severe manic symptoms).
4. Functioning Assessment Short Test [ Time Frame: Change between baseline and 3 months ]
   Brief instrument designed to assess the main functioning problems experienced by psychiatric patients, particularly bipolar patients
5. Functioning Assessment Short Test [ Time Frame: Change between baseline and 15 months ]
   Brief instrument designed to assess the main functioning problems experienced by psychiatric patients, particularly bipolar patients
6. State/Trait Anxiety Inventory [ Time Frame: Change between baseline and 3 months ]
   self-report measure for assessing both state and trait levels of anxiety
7. State/Trait Anxiety Inventory [ Time Frame: Change between baseline and 15 months ]
   self-report measure for assessing both state and trait levels of anxiety
8. Ruminative Response Scale - brooding subscale [ Time Frame: Change between baseline and 3 months ]
   Brooding subscale of the extended version of the Ruminative Response Scale (RRS-EXT). The authors reported adequate internal consistency (α = .79) and test-retest stability (α = .62, with a one year time interval) for the brooding subscale, which consists of five items. We select the brooding subscale because over time, brooding, or rumination, has been more strongly related to levels of depression (Treynor et al., 2003). Items are scored between 1 ((almost) never) to 4 ((almost) always and subscale score ranges between 5 and 20. A higher score indicates a higher level of ruminative brooding.
9. Ruminative Response Scale - brooding subscale [ Time Frame: Change between baseline and 15 months ]
   Brooding subscale of the extended version of the Ruminative Response Scale (RRS-EXT). The authors reported adequate internal consistency (α = .79) and test-retest stability (α = .62, with a one year time interval) for the brooding subscale, which consists of five items. We select the brooding subscale because over time, brooding, or rumination, has been more strongly related to levels of depression (Treynor et al., 2003). Items are scored between 1 ((almost) never) to 4 ((almost) always and subscale score ranges between 5 and 20. A higher score indicates a higher level of ruminative brooding.
10. Five Facet Mindfulness Questionnaire, short form [ Time Frame: Change between baseline and 3 months ]
    Self-report measure consisting of 24 items divided into the subscales observing, describing, acting with awareness, non-judging and non-reactivity.
11. Five Facet Mindfulness Questionnaire, short form [ Time Frame: Change between baseline and 15 months ]
    Self-report measure consisting of 24 items divided into the subscales observing, describing, acting with awareness, non-judging and non-reactivity.
12. Self-Compassion Scale [ Time Frame: Change between baseline and 3 months ]
    Self-Compassion Scale - short form (SCS-SF). The present study will use the 12-item Dutch short-form version of the SCS-SF to measure self-compassion. The scale consists of six components, including self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification. The SCS-SF has good reliability and validity (Raes et al., 2011). In the short form, each scale consists of 2 items scored between 1 ((almost) never) to 7 ((almost) always) and subscale score ranges between 2 and 14. A higher score indicates a higher level of self-kindness, common humanity, and mindfulness, and lower scores of self-judgment, isolation, and over-identification. Total scores range from 12 to 84 (summed subscale scores), a higher score indicates a higher level of selfcompassion.
13. Self-Compassion Scale [ Time Frame: Change between baseline and 15 months ]
    Self-Compassion Scale - short form (SCS-SF). The present study will use the 12-item Dutch short-form version of the SCS-SF to measure self-compassion. The scale consists of six components, including self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification. The SCS-SF has good reliability and validity (Raes et al., 2011). In the short form, each scale consists of 2 items scored between 1 ((almost) never) to 7 ((almost) always) and subscale score ranges between 2 and 14. A higher score indicates a higher level of self-kindness, common humanity, and mindfulness, and lower scores of self-judgment, isolation, and over-identification. Total scores range from 12 to 84 (summed subscale scores), a higher score indicates a higher level of selfcompassion.
14. Mental Health Continuum - short form [ Time Frame: Change between baseline and 3 months ]
    A 14-item self-report questionnaire that assesses emotional, psychological and social well-being
15. Mental Health Continuum - short form [ Time Frame: Change between baseline and 15 months ]
    A 14-item self-report questionnaire that assesses emotional, psychological and social well-being
16. Inventory of Depressive Symptomatology [ Time Frame: 6 months ]
    A clinican-administered interview assessing the severity of depressive symptoms
17. Inventory of Depressive Symptomatology [ Time Frame: 9 months ]
    A clinican-administered interview assessing the severity of depressive symptoms
18. Inventory of Depressive Symptomatology [ Time Frame: 12 months ]
    A clinican-administered interview assessing the severity of depressive symptoms
19. Inventory of Depressive Symptomatology [ Time Frame: 15 months ]
    A clinican-administered interview assessing the severity of depressive symptoms

Other Outcome Measures:

1. Euro-Quality of Life 5D-5L [ Time Frame: baseline ]
   Short self-report instrument to assess quality adjusted life years
2. Euro-Quality of Life 5D-5L [ Time Frame: 3 months ]
   Short self-report instrument to assess quality adjusted life years
3. Euro-Quality of Life 5D-5L [ Time Frame: 6 months ]
   Short self-report instrument to assess quality adjusted life years
4. Euro-Quality of Life 5D-5L [ Time Frame: 9 months ]
   Short self-report instrument to assess quality adjusted life years
5. Euro-Quality of Life 5D-5L [ Time Frame: 12 months ]
   Short self-report instrument to assess quality adjusted life years
6. Euro-Quality of Life 5D-5L [ Time Frame: 15 months ]
   Short self-report instrument to assess quality adjusted life years
7. Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness [ Time Frame: baseline ]
   Health service receipt interview designed for economic evaluations in the Netherlands
8. Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness [ Time Frame: 3 months ]
   Health service receipt interview designed for economic evaluations in the Netherlands
9. Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness [ Time Frame: 6 months ]
   Health service receipt interview designed for economic evaluations in the Netherlands
10. Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness [ Time Frame: 9 months ]
    Health service receipt interview designed for economic evaluations in the Netherlands
11. Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness [ Time Frame: 12 months ]
    Health service receipt interview designed for economic evaluations in the Netherlands
12. Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness [ Time Frame: 15 months ]
    Health service receipt interview designed for economic evaluations in the Netherlands

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Netherlands

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands, 6525 GC

Dimence GGZ

Deventer, Netherlands

Pro Persona

Nijmegen, Netherlands

Altrecht GGZ

Utrecht, Netherlands

Sponsors and Collaborators

Radboud University Medical Center

ZonMw: The Netherlands Organisation for Health Research and Development

Pro Persona

Altrecht

Dimence

PsyQ

Investigators

• Principal Investigator: Anne Speckens, Prof.; Radboud University Medical Center

  Study Documents (Full-Text)

Documents provided by Anne Speckens, Radboud University Medical Center:

Study Protocol  [PDF] March 26, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Anne Speckens, Prof. dr., Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT03507647
• Other Study ID Numbers: MBCT-BD-2017-2021
• First Posted: April 25, 2018
• Last Update Posted: October 29, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: The authors intend to make the data available to other researchers after completion of the study and will comply with open access procedures, including open access publishing, as much as possible.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anne Speckens, Radboud University Medical Center:

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

Additional relevant MeSH terms:

Bipolar Disorder; Bipolar and Related Disorders; Mental Disorders