Clinical trial NCT03507647: Mindfulness Based Cognitive Therapy for Bipolar Disorder
Official title: Mindfulness Based Cognitive Therapy for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: randomized controlled trial
Mindfulness based cognitive therapy
clinical effectiveness
cost-effectiveness
working mechanisms
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Pro Persona Mental Health Care Foundation
name: Altrecht
name: Dimence
name: PsyQ
First posted: 2018-04-25
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, multicenter, prospective, evaluator-blinded clinical trial of MBCT added to treatment as usual (TAU) versus TAU alone
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Inventory of Depressive Symptomatology
timeFrame: Change between baseline and 3 months
Secondary outcomes:
measure: Structured Clinical Interview for DSM-IV-TR Disorders
timeFrame: Change between baseline and 15 months
measure: Young Mania Rating Scale
timeFrame: Change between baseline and 3 months
measure: Young Mania Rating Scale
timeFrame: Change between baseline and 15 months
measure: Functioning Assessment Short Test
timeFrame: Change between baseline and 3 months
measure: Functioning Assessment Short Test
timeFrame: Change between baseline and 15 months
measure: State/Trait Anxiety Inventory
timeFrame: Change between baseline and 3 months
measure: State/Trait Anxiety Inventory
timeFrame: Change between baseline and 15 months
measure: Ruminative Response Scale - brooding subscale
timeFrame: Change between baseline and 3 months
measure: Ruminative Response Scale - brooding subscale
timeFrame: Change between baseline and 15 months
measure: Five Facet Mindfulness Questionnaire, short form
timeFrame: Change between baseline and 3 months
measure: Five Facet Mindfulness Questionnaire, short form
timeFrame: Change between baseline and 15 months
measure: Self-Compassion Scale
timeFrame: Change between baseline and 3 months
measure: Self-Compassion Scale
timeFrame: Change between baseline and 15 months
measure: Mental Health Continuum - short form
timeFrame: Change between baseline and 3 months
measure: Mental Health Continuum - short form
timeFrame: Change between baseline and 15 months
measure: Inventory of Depressive Symptomatology
timeFrame: 6 months
measure: Inventory of Depressive Symptomatology
timeFrame: 9 months
measure: Inventory of Depressive Symptomatology
timeFrame: 12 months
measure: Inventory of Depressive Symptomatology
timeFrame: 15 months
Other outcomes:
measure: Euro-Quality of Life 5D-5L
timeFrame: baseline
measure: Euro-Quality of Life 5D-5L
timeFrame: 3 months
measure: Euro-Quality of Life 5D-5L
timeFrame: 6 months
measure: Euro-Quality of Life 5D-5L
timeFrame: 9 months
measure: Euro-Quality of Life 5D-5L
timeFrame: 12 months
measure: Euro-Quality of Life 5D-5L
timeFrame: 15 months
measure: Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness
timeFrame: baseline
measure: Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness
timeFrame: 3 months
measure: Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness
timeFrame: 6 months
measure: Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness
timeFrame: 9 months
measure: Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness
timeFrame: 12 months
measure: Trimbos/iMTA Questionnaire on Costs associated with Psychiatric illness
timeFrame: 15 months
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Center
state: Gelderland
city: Deventer
country: Netherlands
facility: Dimence GGZ
city: Nijmegen
country: Netherlands
facility: Pro Persona
city: Utrecht
country: Netherlands
facility: Altrecht GGZ
Study officials:
affiliation: Radboud University Medical Center
name: Anne Speckens, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.