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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

February 16, 2010
June 6, 2011
February 2010
August 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01070134 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial

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)
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Personality Disorder
  • 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.

  • 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.

  • Experimental: Mindfulness-based Behavioural Therapy (MIBT)
    Intervention: Behavioral: Mindfulness-based Behavioural Therapy (MIBT)
  • Active Comparator: PT (psychodynamic therapy)
    Intervention: Behavioral: PT (psychodynamic therapy)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Janus Christian Jakobsen, Medical doctor +45 26186242 janusjakobsen@mac.com
Contact: Erik Simonsen, Associate professor 47 327733 es@regionsjaelland.dk
Denmark
 
NCT01070134
Mipsy trial
Yes
Janus Jakobsen
Psychiatry Roskilde
Not Provided
Not Provided
Psychiatry Roskilde
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP