Mindfulness Based Cognitive Therapy for Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Inventory of Depressive Symptomatology
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes will be assessed by independent research assistants blind to condition. Participants will be instructed to avoid unblinding as much as possible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mindfulness Based Cognitive Therapy (Behavioral)
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.
干预措施: Usual Care (Other)
Usual Care
Usual care will typically consist of pharmacotherapy, psycho-education and self-management interventions (usually with a psychiatric nurse).
干预措施: Usual Care (Other)
结局指标
主要结局
Inventory of Depressive Symptomatology
时间窗: Change between baseline and 3 months
A clinican-administered interview assessing the severity of depressive symptoms
次要结局
- Young Mania Rating Scale(Change between baseline and 15 months)
- 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)
- 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)
- Functioning Assessment Short Test(Change between baseline and 3 months)
- Young Mania Rating Scale(Change between baseline and 3 months)
- State/Trait Anxiety Inventory(Change between baseline and 3 months)
- Inventory of Depressive Symptomatology(9 months)
- Inventory of Depressive Symptomatology(12 months)
- Ruminative Response Scale - brooding subscale(Change between baseline and 3 months)
- Five Facet Mindfulness Questionnaire, short form(Change between baseline and 3 months)
- Self-Compassion Scale(Change between baseline and 3 months)
- Mental Health Continuum - short form(Change between baseline and 3 months)
- Inventory of Depressive Symptomatology(6 months)
研究者
Anne Speckens
Prof. dr.
Radboud University Medical Center