The aim of this study is to examine whether MBCT is also effective in patients with chronic, treatment-resistant depression in a mental healthcare setting.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will consist of a reduction in depressive symptoms
according to the Inventory of Depression symptomatology (IDS-SR, Rush, Gullion,
Base et al, 1996).
Secondary outcome
Secondary outcomes will include: rumination (Ruminative Response Scale and
Rumination on Sadness Scale (Raes et al, 2003), mindfulness skills (Five Facet
Mindfulness Questionnaire, Baer et al, 2006), self-compassion (Self Compassion
Scale; Neff, 2003) and quality of life (QOL WHO, World health Organization,
2004) and general health (EQ-5D; Dolan et al, 1997).
Background summary
Depression is a major public health problem with high prevalence and burden of
disease. A large number of patients
not improve with currently available psychopharmacological and psychological
treatments. Mindfulness based cognitive therapy
(MBCT) has proven to be effective in preventing relapse in patients with
recurrent depression.
Earlier, uncontrolled study showed that MBCT can also be effective in patients
who are currently depressed (Kenny et al, 2007). In a small randomized trial of
MBCT in 28 depressed patients with chronic and recurrent course of disease,
also demonstrated a 50% reduction in depressive complaints (Barnhofer et al,
2009). Seven of the 10 depressed participants in the MBCT group did afterwards
no longer meet the diagnostic criteria. A recent randomized trial conducted by
us of more than 200 patients with recurrent depression also showed that MBCT is
as effective in people who are currently depressed as those who are in
remission (of Aalderen et al, 2011). The effect size of MBCT in reducing
depression was large (Cohen's d = 0.53) and independent of the degree of
depressive symptoms at the start of the treatment.
The effectiveness of MBCT in people with recurrent depression who are currently
depressed creates interesting possibilities to investigate the effectiveness of
MBCT in people with chronic, treatment-resistant depression. MBCT has so far
only included in the guideline for those with three or more previous
depressions and is not offered to our target group. In addition to specific
effects on cognition and mood MBCT can also potentially contribute to the
feeling of empowerment among people with chronic depression while the manner of
offering (group training) meets the need for support and contact with fellow
sufferers. Not only can MBCT in patients with chronic, treatment-resistant
depression result in a reduction of complaints, but also in a reduction of the
related care and therefore costs.
Study objective
The aim of this study is to examine whether MBCT is also effective in patients
with chronic, treatment-resistant depression in a mental healthcare setting.
Study design
The study design will be a randomized clinical trial with a crossover design.
Patients will be randomized after a baseline interview about MBCT added to the
regular treatment and regular treatment as usual. The control condition wil
receive MBCT after three moniths. The two groups will be followed for six
months.
Intervention
Mindfulness based cognitive therapy (MBCT) compared with treatment as usual.
Study burden and risks
For the patients randomized into either the MBCT condition or treatment as
usual condition, the burden will consist of participation in the 8-week course.
In addition, the participants are expected to do exercises at home
daily.Furthermore, all patients get a baseline interview (about one hour) and
three follow-up visits with several measurements (about one hour). The control
condition will have four follow-up visits as they start with care as susal of
three months.
Reinier Postlaan 6
Nijmegen 6525 GC
NL
Reinier Postlaan 6
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Patients with a major depressive disorder (according to DSM-IV) with a duration of one year or longer. Patients have responded insufficiently (IDS >21, moderate depression) to a therapeutic dose of antidepressant medication and a psychotherapy protocol (cognitive behavioral therapy or interpersonal psychotherapy).
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL41357.091.12 |
| OMON | NL-OMON27713 |