Bipolar DisorderMBCT-BDNCT03507647
Mindfulness Based Cognitive Therapy for Bipolar Disorder
A study testing Mindfulness Based Cognitive Therapy in people with Bipolar Disorder, run by Radboud University Medical Center at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 4 sitesNetherlands
- Study dates
- 23 Apr 2018to 17 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Dimence GGZ
Deventer
Radboud University Nijmegen Medical Center
Nijmegen, Gelderland, 6525 GC
Pro Persona
Nijmegen
Altrecht GGZ
Utrecht
About this study
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.
Read the 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).
- Conditions
- Bipolar Disorder
- Being tested
- Mindfulness Based Cognitive Therapy, Usual Care
- Keywords
- randomized controlled trial, Mindfulness based cognitive therapy, clinical effectiveness, cost-effectiveness, working mechanisms
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called MBCT, Mindfulness training
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Depressive Symptomatology
A clinican-administered interview assessing the severity of depressive symptoms
Measured: Change between baseline and 3 months
Secondary outcomes (19)
Structured Clinical Interview for DSM-IV-TR Disorders
Diagnostic instrument to assess relapse of depressive or (hypo)manic episode
Measured: Change between baseline and 15 months
Young Mania Rating Scale
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).
Measured: Change between baseline and 3 months
Young Mania Rating Scale
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).
Measured: Change between baseline and 15 months
Functioning Assessment Short Test
Brief instrument designed to assess the main functioning problems experienced by psychiatric patients, particularly bipolar patients
Measured: Change between baseline and 3 months
Functioning Assessment Short Test
Brief instrument designed to assess the main functioning problems experienced by psychiatric patients, particularly bipolar patients
Measured: Change between baseline and 15 months
State/Trait Anxiety Inventory
self-report measure for assessing both state and trait levels of anxiety
Measured: Change between baseline and 3 months
State/Trait Anxiety Inventory
self-report measure for assessing both state and trait levels of anxiety
Measured: Change between baseline and 15 months
Ruminative Response Scale - brooding subscale
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.
Measured: Change between baseline and 3 months
Ruminative Response Scale - brooding subscale
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.
Measured: Change between baseline and 15 months
Five Facet Mindfulness Questionnaire, short form
Self-report measure consisting of 24 items divided into the subscales observing, describing, acting with awareness, non-judging and non-reactivity.
Measured: Change between baseline and 3 months
Five Facet Mindfulness Questionnaire, short form
Self-report measure consisting of 24 items divided into the subscales observing, describing, acting with awareness, non-judging and non-reactivity.
Measured: Change between baseline and 15 months
Self-Compassion Scale
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.
Measured: Change between baseline and 3 months
Self-Compassion Scale
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.
Measured: Change between baseline and 15 months
Mental Health Continuum - short form
A 14-item self-report questionnaire that assesses emotional, psychological and social well-being
Measured: Change between baseline and 3 months
Mental Health Continuum - short form
A 14-item self-report questionnaire that assesses emotional, psychological and social well-being
Measured: Change between baseline and 15 months
Inventory of Depressive Symptomatology
A clinican-administered interview assessing the severity of depressive symptoms
Measured: 6 months
Inventory of Depressive Symptomatology
A clinican-administered interview assessing the severity of depressive symptoms
Measured: 9 months
Inventory of Depressive Symptomatology
A clinican-administered interview assessing the severity of depressive symptoms
Measured: 12 months
Inventory of Depressive Symptomatology
A clinican-administered interview assessing the severity of depressive symptoms
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start23 Apr 2018
- Primary completion16 Jun 2020
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multicenter, prospective, evaluator-blinded clinical trial of MBCT added to treatment as usual (TAU) versus TAU alone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Pro Persona Mental Health Care Foundation, Altrecht, Dimence, PsyQ
- Responsible party
- Principal investigator, Anne Speckens, Radboud University Medical Center
- Investigators
- Anne Speckens, Prof., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507647
- Sponsor's protocol ID
- MBCT-BD-2017-2021
- Acronym
- MBCT-BD
- Status last verified
- Apr 2023
- First submitted
- 18 Sep 2017
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 39625263Hanssen 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.
PubMed 34735517Hanssen 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.
PubMed 33175338Hanssen 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.
PubMed 31039765
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Cognitive Therapy for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03507647
- Acronym / sponsor ID
- MBCT-BD / MBCT-BD-2017-2021
- Conditions
- Bipolar Disorder
- Keywords
- randomized controlled trial, Mindfulness based cognitive therapy, clinical effectiveness, cost-effectiveness, working mechanisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Pro Persona Mental Health Care Foundation, Altrecht, Dimence, PsyQ
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, multicenter, prospective, evaluator-blinded clinical trial of MBCT added to treatment as usual (TAU) versus TAU alone
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy added to usual care | Experimental | Behavioral: Mindfulness Based Cognitive Therapy, Other: Usual CarePatients in the MBCT arm will be invited to participate in MBCT added to their usual care. |
| Usual Care | Active comparator | Other: Usual CareUsual care will typically consist of pharmacotherapy, psycho-education and self-management interventions (usually with a psychiatric nurse). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyAlso: MBCT, Mindfulness trainingMBCT 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. | Behavioural | Mindfulness Based Cognitive Therapy added to usual care |
| Usual CareUsual 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. | Other | Mindfulness Based Cognitive Therapy added to usual care, Usual Care |
Primary outcome
Inventory of Depressive Symptomatology
Time frame: Change between baseline and 3 months
A clinican-administered interview assessing the severity of depressive symptoms
19 secondary outcomes
Structured Clinical Interview for DSM-IV-TR Disorders
Time frame: Change between baseline and 15 months
Young Mania Rating Scale
Time frame: Change between baseline and 3 months
Young Mania Rating Scale
Time frame: Change between baseline and 15 months
Functioning Assessment Short Test
Time frame: Change between baseline and 3 months
Functioning Assessment Short Test
Time frame: Change between baseline and 15 months
State/Trait Anxiety Inventory
Time frame: Change between baseline and 3 months
State/Trait Anxiety Inventory
Time frame: Change between baseline and 15 months
Ruminative Response Scale - brooding subscale
Time frame: Change between baseline and 3 months
Ruminative Response Scale - brooding subscale
Time frame: Change between baseline and 15 months
Five Facet Mindfulness Questionnaire, short form
Time frame: Change between baseline and 3 months
Five Facet Mindfulness Questionnaire, short form
Time frame: Change between baseline and 15 months
Self-Compassion Scale
Time frame: Change between baseline and 3 months
Self-Compassion Scale
Time frame: Change between baseline and 15 months
Mental Health Continuum - short form
Time frame: Change between baseline and 3 months
Mental Health Continuum - short form
Time frame: Change between baseline and 15 months
Inventory of Depressive Symptomatology
Time frame: 6 months
Inventory of Depressive Symptomatology
Time frame: 9 months
Inventory of Depressive Symptomatology
Time frame: 12 months
Inventory of Depressive Symptomatology
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39625263Hanssen 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.
- Derived from this study: PubMed 34735517Hanssen 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.
- Derived from this study: PubMed 33175338Hanssen 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.
- Derived from this study: PubMed 31039765Hanssen 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Speckens, Prof. principal investigator
Radboud University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Bipolar Disorder, run by Radboud University Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Depressive Symptomatology (time frame: Change between baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507647, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 27 Oct 2026.