Mindfulness Based Cognitive Therapy for Bipolar Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 144
- Locations
- 5
- Primary Endpoint
- Inventory of Depressive Symptomatology
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Inventory of Depressive Symptomatology
Time Frame: Change between baseline and 3 months
A clinican-administered interview assessing the severity of depressive symptoms
Secondary Outcomes
- Structured Clinical Interview for DSM-IV-TR Disorders(Change between baseline and 15 months)
- Five Facet Mindfulness Questionnaire, short form(Change between baseline and 15 months)
- Ruminative Response Scale - brooding subscale(Change between baseline and 15 months)
- Self-Compassion Scale(Change between baseline and 15 months)
- Inventory of Depressive Symptomatology(15 months)
- Young Mania Rating Scale(Change between baseline and 15 months)
- Functioning Assessment Short Test(Change between baseline and 15 months)
- State/Trait Anxiety Inventory(Change between baseline and 15 months)
- Mental Health Continuum - short form(Change between baseline and 15 months)
Investigators
Anne Speckens
Prof. dr.
Radboud University Medical Center