Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial (Mipsy)

• ClinicalTrials.gov Identifier: NCT01070134
• Recruitment Status: Unknown
• First Posted: February 17, 2010
• Last Update Posted: June 8, 2011
• Sponsor: Psychiatry Roskilde
• Information provided by: Psychiatry Roskilde

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder; Personality Disorder	Behavioral: Mindfulness-based Behavioural Therapy (MIBT); Behavioral: PT (psychodynamic therapy)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. The proportion of patients who achieve remission (Hamilton score < 8). [ Time Frame: 0 weeks, 18 weeks, and 1 year ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Aged 18 to 65 years
2. Major depressive disorder (SCID I).
3. BDI II > 13.
4. Written informed consent.

Exclusion Criteria:

1. Current psychosis, diagnosis of schizophrenia or schizotypal personality disorder (DSM IV-TR).
2. Alcohol or substance abuse judged to require treatment in preference to depression (assessed during patient conference).
3. Commenced or changed psychopharmacological treatment less than six weeks before randomisation.
4. Pregnancy.
5. No written informed consent.

Contacts and Locations

Contacts

Contact: Janus Christian Jakobsen, Medical doctor; +45 26186242; janusjakobsen@mac.com

Contact: Erik Simonsen, Associate professor; 47 327733; es@regionsjaelland.dk

Locations

Denmark

The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry); Recruiting

Roskilde, Zeeland, Denmark, 4000

Contact: Erik Simonsen, Associate professor +4547327733 es@regionsjaelland.dk

Contact: Kirsten Larsen, Medical doctor 47327733 kala@regionsjaelland.dk

Principal Investigator: Janus Christian Jakobsen

Sponsors and Collaborators

Psychiatry Roskilde

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Jakobsen 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.

• Responsible Party: Janus Jakobsen
• ClinicalTrials.gov Identifier: NCT01070134
• Other Study ID Numbers: Mipsy trial
• First Posted: February 17, 2010
• Last Update Posted: June 8, 2011
• Last Verified: February 2010

Additional relevant MeSH terms:

Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Personality Disorders; Pathologic Processes; Mood Disorders; Mental Disorders; Behavioral Symptoms