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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)

Primary Purpose

Major Depressive Disorder, Personality Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mindfulness-based Behavioural Therapy (MIBT)
PT (psychodynamic therapy)
Sponsored by
Psychiatry Roskilde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based Behavioural Therapy (MIBT)

PT (psychodynamic therapy)

Arm Description

Outcomes

Primary Outcome Measures

17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)

Secondary Outcome Measures

SCL-90-R (GSI score at the end of 18 weeks of day- treatment)
The proportion of patients who achieve remission (Hamilton score < 8).

Full Information

First Posted
February 16, 2010
Last Updated
June 6, 2011
Sponsor
Psychiatry Roskilde
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1. Study Identification

Unique Protocol Identification Number
NCT01070134
Brief Title
Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
Acronym
Mipsy
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Psychiatry Roskilde

4. Oversight

Data Monitoring Committee
Yes

5. 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: MIBT (mindfulness-based behavioural therapy) PT (psychodynamic therapy)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based Behavioural Therapy (MIBT)
Arm Type
Experimental
Arm Title
PT (psychodynamic therapy)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Behavioural Therapy (MIBT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PT (psychodynamic therapy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
The proportion of patients who achieve remission (Hamilton score < 8).
Time Frame
0 weeks, 18 weeks, and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 to 65 years Major depressive disorder (SCID I). BDI II > 13. Written informed consent. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janus Christian Jakobsen, Medical doctor
Phone
+45 26186242
Email
janusjakobsen@mac.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erik Simonsen, Associate professor
Phone
47 327733
Email
es@regionsjaelland.dk
Facility Information:
Facility Name
The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)
City
Roskilde
State/Province
Zeeland
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Simonsen, Associate professor
Phone
+4547327733
Email
es@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Kirsten Larsen, Medical doctor
Phone
47327733
Email
kala@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Janus Christian Jakobsen

12. IPD Sharing Statement

Citations:
PubMed Identifier
25138802
Citation
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.
Results Reference
derived
PubMed Identifier
23253305
Citation
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.
Results Reference
derived

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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

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