Bipolar disorder
Conditions
Interventions
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) de
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.
M
Sponsors
Radboudumc
Eligibility
Age
18 Years to 99 Years
Inclusion 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) -having suffered at least one episode (depressed or (hypo)manic) within the year prior to baseline. - Young Mania Rating Scale score
Exclusion criteria
Exclusion criteria: - a (hypo)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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of the study is severity of depressive symptoms at 3 months follow-up (T1), assessed with the Inventory of Depressive Symptomatology * Clinician administered (IDS-C; Akkerhuis, 1997). The IDS-C has good psychometric qualities (Rush et al. 1996; Trivedi et al. 2004) and will be administered by trained research assistants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinician-administered measures: - Structured Clinical Interview for DSM-IV-TR Disorders (SCID; First, 2002) or its successor for DSM 5 when available, to assess depressive and manic relapses. The SCID will be used to retrospectively assess possible relapses/recurrences in the past 3 months at each time point. - Young Mania Rating Scale (YMRS; Young, 1978), an 11-item clinician-administered rating scale to assess the level of (hypo)manic symptoms. It has good inter-rater reliability. - Functioning Assessment Short Test (FAST; Rosa, 2007), Dutch translation. The FAST is a brief instrument designed to assess the main functioning problems experienced by psychiatric patients, particularly bipolar patients. It comprises 24 items that assess impairment or disability in six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. It has been shown to have strong psychometrics properties in terms of high internal consistency, test-retest reliability, and concurrent validity, and its ability to detect differences between euthymic and acute BD patients (Rosa, 2007). Self-report measures: - State/Trait Anxiety Inventory (STAI; Spielberger, 1983). The STAI is a self-report measure which has been proven reliable and sensitive in the assessment of both state and trait levels of anxiety. It is a standard international measure in anxiety research and its Dutch translation has been validated (van der Ploeg, 2000). - Brooding subscale of the extended version of the Ruminative Response Scale (RRS-EXT; Treynor, 2003). The authors reported adequate internal consistency a = .79 and test*retest stability (a = .62, 1 year time interval) for the brooding subscale, which consists of 5 items. We select the brooding subscale because over time, brooding has been related to higher levels of depression, whereas the reflection subscale has been linked to lower levels of | — |
Countries
Netherlands
Outcome results
None listed