Abstract
BackgroundDespite multiple pharmacological interventions, many people with bipolar disorder (BD) experience substantial residual mood symptoms, even in the absence of severe mood episodes, which have a negative impact on the course of illness and quality of life. Limited data are available on how to optimize treatment for BD, especially for those who suffer from persistent and residual depressive symptoms. Preliminary evidence suggests Mindfulness-Based Cognitive Therapy (MBCT) as a psychological treatment option for BD. This study aims to investigate whether adding MBCT to treatment as usual (TAU) will result in symptomatic and functional improvements in adults with BD compared to TAU alone.Methods/designThis study is a prospective, evaluator blinded, multicenter, randomized controlled trial of MBCT + TAU and TAU alone in 160 adults with bipolar type I and type II. Assessments will be conducted at baseline (T0), mid-treatment (Tmid), and at 3 (T1), 6 (T2), 9 (T3), 12 (T4), and 15 (T5) months follow-up. Primary outcome is post-treatment severity of depressive symptoms (Inventory of Depressive Symptomatology- Clinician administered). Secondary outcomes are severity of (hypo) manic symptoms, anxiety, relapse rates, overall functioning, positive mental health, and cost-effectiveness. As possible mediators will be assessed rumination of negative affect, dampening and rumination of positive affect, mindfulness skills, and self-compassion.DiscussionThis study will provide valuable insight into the (cost-)effectiveness of MBCT on clinician- and self-rated symptoms of BD, relapse rates, positive mental health, and overall functioning.Trial registrationNCT03507647. Registered 25th of April 2018.
Highlights
Despite multiple pharmacological interventions, many people with bipolar disorder (BD) experience substantial residual mood symptoms, even in the absence of severe mood episodes, which have a negative impact on the course of illness and quality of life
Most psychological interventions used in the treatment of BD, such as Cognitive Behavioral Therapy (CBT), are more effective for people with major depression or in people with BD who suffered less than 12 mood episodes [16,17,18]
The current trial will be the first properly powered, multicenter, randomized controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) for BD in the Netherlands and the second world-wide. It will provide high-level evidence of the relative long-term effectiveness of MBCT + treatment as usual (TAU) compared to TAU alone by including follow-up measurements up to 15 months en keeping close track of treatment adherence and occurrence of adverse reactions
Summary
Many people with bipolar disorder (BD) experience substantial residual mood symptoms, even in the absence of severe mood episodes, which have a negative impact on the course of illness and quality of life. Limited data are available on how to optimize treatment for BD, especially for those who suffer from persistent and residual depressive symptoms. 60% of people with BD relapse in a full-blown mood episode within two years after recovering from a previous mood episode [6, 11,12,13] These persistent mood symptoms affect the course of BD and quality of life negatively [14]. Most psychological interventions used in the treatment of BD, such as Cognitive Behavioral Therapy (CBT), are more effective for people with major depression or in people with BD who suffered less than 12 mood episodes [16,17,18]. Limited data are available on how to optimize treatment for the whole population of people with BD, especially for those who suffer from persistent and residual mood symptoms
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