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Mindfulness-based Cognitive Therapy for Chronic Depression

Primary Purpose

Chronic Major Depression

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness-based Cognitive Therapy
The Cognitive Behavioral Analysis System of Psychotherapy
Standard psychiatric care
Sponsored by
Johannes Michalak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Major Depression focused on measuring Depressive Disorder, Psychotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnoses of Major Depression, single episode, chronic or
  • Major Depression, recurrent, chronic
  • Hamilton Rating Scale for Depression score > 14
  • Beck Depression Inventory II score > 14

Exclusion Criteria:

  • History of Schizophrenia or Schizoaffective Disorder
  • Current Substance Dependence or Eating Disorder
  • Mental Disorder Due to General Medical Condition
  • Borderline Personality Disorder

Sites / Locations

  • University of Hildesheim

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Mindfulness-based Cognitive Therapy

CBASP

Treatment-as-usual

Arm Description

Mindfulness-based Cognitive Therapy is based on an integration of certain aspects of cognitive behavioral therapy for depression (Beck et al., 1979) and components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.

The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions.

Standard psychiatric outpatient care: All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

Secondary Outcome Measures

Beck Depression Inventory II
Social Adaption Self-evaluation Scale
Short Form (36) Health Survey
Global Assessment of Functioning Scale
Response Styles Questionnaire
Beck Depression Inventory II
Social Adaption Self-evaluation Scale
Short Form (36) Health Survey
Global Assessment of Functioning Scale
Response Styles Questionnaire

Full Information

First Posted
February 8, 2010
Last Updated
May 14, 2014
Sponsor
Johannes Michalak
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1. Study Identification

Unique Protocol Identification Number
NCT01065311
Brief Title
Mindfulness-based Cognitive Therapy for Chronic Depression
Official Title
Mindfulness-based Cognitive Therapy for Chronic Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Johannes Michalak

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The propose of the study is to investigate the efficacy of Mindfulness-based Cognitive Therapy (MBCT, Segal, Williams, & Teasdale, 2002) for patients suffering from Chronic Major Depression. The efficacy of MBCT will be compared with the Cognitive Behavioral Analysis System of Psychotherapy (McCullough, 2003), a treatment approach, which has proven it's efficacy yet, and with a treatment-as-usual condition (standard psychiatric outpatient care).
Detailed Description
Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a treatment approach specifically developed for the treatment of chronic depression. CBASP aims to change dysfunctional interpersonal patterns. Mindfulness-based Cognitive Therapy (MBCT) has recently been proposed as a further treatment option for chronic depression. MBCT trains patients to step out of negative ruminative states of mind. There are no direct comparisons of the psychological treatment options for chronic depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Major Depression
Keywords
Depressive Disorder, Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based Cognitive Therapy
Arm Type
Experimental
Arm Description
Mindfulness-based Cognitive Therapy is based on an integration of certain aspects of cognitive behavioral therapy for depression (Beck et al., 1979) and components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.
Arm Title
CBASP
Arm Type
Active Comparator
Arm Description
The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions.
Arm Title
Treatment-as-usual
Arm Type
Active Comparator
Arm Description
Standard psychiatric outpatient care: All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Cognitive Therapy
Intervention Description
Mindfulness-based Cognitive Therapy is based on an integration of aspects of cognitive behavioral therapy for depression (Beck et al., 1979) with components of the Mindfulness-based Stress Reduction program developed by Kabat-Zinn and colleagues (Kabat-Zinn, 1990). After an initial orientation session, the MBCT program is delivered by an instructor in eight weekly 2.5 hr group sessions
Intervention Type
Behavioral
Intervention Name(s)
The Cognitive Behavioral Analysis System of Psychotherapy
Intervention Description
The Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, and interpersonal strategies. After two initial orientation sessions, the MBCT program is delivered weekly by an instructor in eight 2.5 hr group sessions.
Intervention Type
Biological
Intervention Name(s)
Standard psychiatric care
Other Intervention Name(s)
Psychiatric care, neurologic care, ambulant setting
Intervention Description
Antidepressant medication and medical care. Standard psychiatric outpatient care: All patients were requested to get treated individually either by a psychiatrist or by a licensed psychotherapist (not member of the study team). If patients were already in psychiatric/psychotherapeutic individual treatment at study intake they continued their treatment with this psychiatrist/psychotherapist
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Time Frame
Change from Baseline in HAM-D at 8 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory II
Time Frame
Change from Baseline in BDI-II at 8 weeks
Title
Social Adaption Self-evaluation Scale
Time Frame
Change from Baseline in SASS at 8 weeks
Title
Short Form (36) Health Survey
Time Frame
Change from Baseline in SF-36 at 8 weeks
Title
Global Assessment of Functioning Scale
Time Frame
Change from Baseline in HAM-D at 8 weeks
Title
Response Styles Questionnaire
Time Frame
Change from Baseline in RSQ at 8 weeks
Title
Beck Depression Inventory II
Time Frame
Change from Baseline in BDI-II at 6 months
Title
Social Adaption Self-evaluation Scale
Time Frame
Change from Baseline in SASS at 6 months
Title
Short Form (36) Health Survey
Time Frame
Change from Baseline in SF-36 at 6 months
Title
Global Assessment of Functioning Scale
Time Frame
Change from Baseline in GAF at 6 months
Title
Response Styles Questionnaire
Time Frame
Change from Baseline in RSQ at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnoses of Major Depression, single episode, chronic or Major Depression, recurrent, chronic Hamilton Rating Scale for Depression score > 14 Beck Depression Inventory II score > 14 Exclusion Criteria: History of Schizophrenia or Schizoaffective Disorder Current Substance Dependence or Eating Disorder Mental Disorder Due to General Medical Condition Borderline Personality Disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Michalak, PD Dr. phil.
Organizational Affiliation
University of Hildesheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hildesheim
City
Hildesheim
ZIP/Postal Code
31141
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
27128357
Citation
Forkmann T, Brakemeier EL, Teismann T, Schramm E, Michalak J. The Effects of Mindfulness-Based Cognitive Therapy and Cognitive Behavioral Analysis System of Psychotherapy added to Treatment as Usual on suicidal ideation in chronic depression: Results of a randomized-clinical trial. J Affect Disord. 2016 Aug;200:51-7. doi: 10.1016/j.jad.2016.01.047. Epub 2016 Apr 19.
Results Reference
derived
PubMed Identifier
26371617
Citation
Michalak J, Schultze M, Heidenreich T, Schramm E. A randomized controlled trial on the efficacy of mindfulness-based cognitive therapy and a group version of cognitive behavioral analysis system of psychotherapy for chronically depressed patients. J Consult Clin Psychol. 2015 Oct;83(5):951-63. doi: 10.1037/ccp0000042. Epub 2015 Aug 10.
Results Reference
derived

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Mindfulness-based Cognitive Therapy for Chronic Depression

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