The objective of the present study is to assess the clinical and cost-effectiveness of the combination of Mindfulness Based Cognitive Therapy (MBCT) and Optimal Medical Management (OMM) in terms of reducing the risk of relapse and recurrence in…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure: risk of relapse or recurrence of depression defined by
DSM-IV criteria as assessed by the Structured Clinical Interview for DSM-IV
(SCID; First et al., 1996) and incremental cost-effectiveness ratio.
Secondary outcome
Secondary outcome measures: time to, duration and severity of relapse or
recurrence as assessed by the Inventory of Depression Symptomatology Self Rated
(IDS-SR; Rush et al., 1996), psychiatric comorbidity and quality of life.
Background summary
In comparison with treatment as usual, mindfulness based cognitive therapy
(MBCT) has been demonstrated to significantly reduce the relapse rate in
patients with three or more previous depressive episodes (Teasdale et al.,
2000; Ma & Teasdale, 2004). In a recently completed trial (Kuyken et al.,
2007), MBCT and maintenance antidepressant medication appeared to have
comparable results in patients with recurrent depression, but relapse rates
remained considerable in both conditions.
Study objective
The objective of the present study is to assess the clinical and
cost-effectiveness of the combination of Mindfulness Based Cognitive Therapy
(MBCT) and Optimal Medical Management (OMM) in terms of reducing the risk of
relapse and recurrence in patients with recurrent depression as compared to
either of these treatments alone.
Study design
Multi-center randomised controlled trial (RCT) with three interventions and 15
months post-randomisation follow-up.
Intervention
Combination of mindfulness based cognitive therapy (MBCT) and optimised medical
management (OMM), OMM alone and MBCT alone.
Study burden and risks
Patients randomised to the MBCT or combined condition will be invited to
participate in the 8-week course and will be expected to practice at home on a
daily basis.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients with major depressive disorder with at least three previous depressive episodes.
Patients have been treated with a therapeutic dose of antidepressant medication over the last 6 months.
Patients are currently either in full or partial remission.
Exclusion criteria
Bipolar disorder
Any primary psychotic disorder
Clinically relevant neurological or other somatic illness
Current alcohol or drug misuse
Use of high dosage of benzodiazepines (>2 mg lorazepam equivalents daily)
Recent Electro Convulsive Therapy
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 |
|---|---|
| CCMO | NL24401.091.08 |