Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial (Mipsy)
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|ClinicalTrials.gov Identifier: NCT01070134|
Recruitment Status : Unknown
Verified February 2010 by Psychiatry Roskilde.
Recruitment status was: Recruiting
First Posted : February 17, 2010
Last Update Posted : June 8, 2011
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.
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:
- MIBT (mindfulness-based behavioural therapy)
- PT (psychodynamic therapy)
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Personality Disorder||Behavioral: Mindfulness-based Behavioural Therapy (MIBT) Behavioral: PT (psychodynamic therapy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
|Experimental: Mindfulness-based Behavioural Therapy (MIBT)||
Behavioral: Mindfulness-based Behavioural Therapy (MIBT)
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.
|Active Comparator: PT (psychodynamic therapy)||
Behavioral: PT (psychodynamic therapy)
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.
- 17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment) [ Time Frame: 0 weeks, 18 weeks, and 1 year ]
- SCL-90-R (GSI score at the end of 18 weeks of day- treatment) [ Time Frame: 0 weeks, 9 weeks, 18 weeks, and 1 year ]
- The proportion of patients who achieve remission (Hamilton score < 8). [ Time Frame: 0 weeks, 18 weeks, and 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070134
|Contact: Janus Christian Jakobsen, Medical doctor||+45 firstname.lastname@example.org|
|Contact: Erik Simonsen, Associate professor||47 email@example.com|
|The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)||Recruiting|
|Roskilde, Zeeland, Denmark, 4000|
|Contact: Erik Simonsen, Associate professor +4547327733 firstname.lastname@example.org|
|Contact: Kirsten Larsen, Medical doctor 47327733 email@example.com|
|Principal Investigator: Janus Christian Jakobsen|