Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
Mipsy
1 other identifier
interventional
84
1 country
1
Brief Summary
Background: According to the WHO, major depressive disorder is the second largest healthcare problem worldwide in terms of disability caused by illness. It afflicts an estimated 17% of individuals during their lifetimes at tremendous costs. A number of depressive patients are treated with antidepressant medication. The efficacy of antidepressant medication has been studied in a number of systematic reviews, and in recent years some of these reviews have shown that the efficacy is questionable for many patients. So are there other effective treatments for this serious illness? Cognitive- and psychodynamic therapies are probably both significantly more effective for depression than no treatment, but only limited comparisons have been made between the two interventions. A Cochrane review shows that cognitive therapy has a preventive effect against recurrent depression, and that this effect may surpass the preventive effect of antidepressant medication. Mindfulness training may be an effective technique in preventing relapse in patients who have had at least 3 previous depressive episodes. But efficacy in treating currently depressed patients has not been studied. Objective To perform a randomised clinical trial with blinded assessment of efficacy variables in order to study the effects of mindfulness based behavioral therapy (cognitive therapy and mindfulness) versus psychodynamic therapy in depressive patients. Methods A randomised clinical trial of 84 consecutive patients diagnosed with major depressive disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be randomised to one of two interventions:
- 1.MIBT (mindfulness-based behavioural therapy)
- 2.PT (psychodynamic therapy)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable major-depressive-disorder
Started Feb 2010
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJune 8, 2011
February 1, 2010
1.5 years
February 16, 2010
June 6, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
0 weeks, 18 weeks, and 1 year
Secondary Outcomes (2)
SCL-90-R (GSI score at the end of 18 weeks of day- treatment)
0 weeks, 9 weeks, 18 weeks, and 1 year
The proportion of patients who achieve remission (Hamilton score < 8).
0 weeks, 18 weeks, and 1 year
Study Arms (2)
Mindfulness-based Behavioural Therapy (MIBT)
EXPERIMENTALPT (psychodynamic therapy)
ACTIVE COMPARATORInterventions
The MIBT treatment consists of weekly individual MIBT therapy (45-50 min.), together with weekly mindfulness-skills training group (1.5 hours). The treatment is based on the cognitive model of depression, but will, based on concrete problems, draw from alternative cognitive techniques in order to treat personality-related problems and will use elements from mindfulness.
The PT treatment consists of weekly individual PT therapy (45-50 min.), together with weekly PT group therapy (1.5 hours). The main elements of PT are the free-flowing, non-therapist guided dialogue, based on classic psychoanalytical free association. Basically, the role of the therapist is to set ground rules and organise the time, place and duration, to maintain a proper tone, and ultimately to ensure that a therapeutic process takes place using relevant interventions.
Eligibility Criteria
You may qualify if:
- Aged 18 to 65 years
- Major depressive disorder (SCID I).
- BDI II \> 13.
- Written informed consent.
You may not qualify if:
- Current psychosis, diagnosis of schizophrenia or schizotypal personality disorder (DSM IV-TR).
- Alcohol or substance abuse judged to require treatment in preference to depression (assessed during patient conference).
- Commenced or changed psychopharmacological treatment less than six weeks before randomisation.
- Pregnancy.
- No written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)
Roskilde, Zeeland, 4000, Denmark
Related Publications (2)
Jakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial. BMJ Open. 2014 Aug 19;4(8):e004903. doi: 10.1136/bmjopen-2014-004903.
PMID: 25138802DERIVEDJakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial. BMC Psychiatry. 2012 Dec 19;12:232. doi: 10.1186/1471-244X-12-232.
PMID: 23253305DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
June 8, 2011
Record last verified: 2010-02