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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Psychiatry Roskilde.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Psychiatry Roskilde
ClinicalTrials.gov Identifier:
NCT01070134
First received: February 16, 2010
Last updated: June 6, 2011
Last verified: February 2010
  Purpose

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 Intervention
Major Depressive Disorder
Personality Disorder
Behavioral: Mindfulness-based Behavioural Therapy (MIBT)
Behavioral: PT (psychodynamic therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Psychiatry Roskilde:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The proportion of patients who achieve remission (Hamilton score < 8). [ Time Frame: 0 weeks, 18 weeks, and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: February 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070134

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

No publications provided by Psychiatry Roskilde

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janus Jakobsen
ClinicalTrials.gov Identifier: NCT01070134     History of Changes
Other Study ID Numbers: Mipsy trial
Study First Received: February 16, 2010
Last Updated: June 6, 2011
Health Authority: Danish Data Protection Agency (nr.: 2008-58-0020).

Additional relevant MeSH terms:
Depressive Disorder
Depression
Personality Disorders
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014