As there are limited data on how to improve outcomes for those patients who do not benefit sufficiently from the availabletreatments, this study aims to compare MBCT to TAU as an adjunctive treatment to reduce depressive symptoms in patientswith…
ID
Source
Brief title
Condition
- Manic and bipolar mood disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
depression (Treynor et al. 2003).
- Five Facet Mindfulness Questionnaire, short form (FFMQ-SF Dutch form;
Bohlmeijer et al 2011). The FFMQ-SF consists of 24
items divided into the subscales observing, describing, acting with awareness,
non-judging and non-reactivity. The Dutch
version of the FFMQ-SF has been found reliable, valid, and sensitive to change
in a Dutch sample of depressed individuals
(Bohlmeijer et al. 2011).
- Self-compassion will be measured with the 12-item Dutch short-form version of
the Self-Compassion Scale (SCS-SF; Raes et
al., 2011). The scale consists of six components: self-kindness, self-judgment,
common humanity, isolation, mindfulness and
over-identification. The SCS-SF has good reliability and validity.
-Mental Health Continuum * short form (MHC-SF; Lamers, 2011). The MHC-SF is a
14-item self-report questionnaire that
assesses emotional, psychological and social well-being. It has adequate
psychometric qualities in terms of good internal
consistency, (moderate) test-retest reliability, and good divergent and
convergent validity.
- For the economic evaluation evaluation patients will complete a QALY
instruments (EQ-5D-5L; EuroQoL Group, 1995) and a
resource use measurement instrument (Tic-P; Hakkaart - van Roijen et al. 2002).
Background summary
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.
Study objective
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. We aim to examine outcomes of MBCT for BD patients 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.
Study design
A randomized, multicenter, prospective, evaluator-blinded clinical trial of
MBCT added to treatment as usual (TAU) versus TAU
alone is proposed. Assessments will be conducted at baseline and at 3, 6, 9, 12
and 15 months follow-up.
Intervention
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 psychoeduction 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).
Study burden and risks
The burden associated with participation in MBCT is relatively high:
participants are asked to attend 8 weekly group sessions of 2,5 hours and one
silent day (6 hours), and to practice at home for about 45 minutes a day. In
addition, participants are invited for 6 research assessments, 3 face-to-face
(1-2 hours) and 3 by telephone (about 30 minutes). Assessments consist of
interviews and questionnaires that ask about psychological symptoms,
functioning, and quality of life. Before and after the intervention the
assessment will include computer tasks.
Although the effort requested from patients is high, we expect that the large
amount of practice will be associated with enduring changes in patients'
coping, and that patients are increasingly able to apply mindfulness in their
daily life. In this way, the intervention (and effort) can increase
participants' autonomy and self-efficacy.
The risks associated with participated are expected to be low. Participants
learn mindfulness skills to cope with psychological distress in a more
effective way. This may include increased awareness of difficult emotions,
which may at first be confronting or overwhelming. This is a major topic that
will be discussed during MBCT and if participants show a clear increase in
symptoms, additional guidance will be offered. Participants are encouraged to
respect their boundaries (both physical and psychological) and are always free
to quit or adapt the practice as needed.
Reinier Postlaan 10
Nijmegen 6525 GC
NL
Reinier Postlaan 10
Nijmegen 6525 GC
NL
Listed location countries
Age
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 < 8
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCTnotyetassigned |
CCMO | NL63319.091.17 |