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Mindfulness-based Cognitive Therapy for Chronic Depression

This study is currently recruiting participants.
Verified July 2011 by Ruhr University of Bochum
Sponsor:
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01065311
First received: February 8, 2010
Last updated: July 20, 2011
Last verified: July 2011
History of Changes

February 8, 2010
July 20, 2011
October 2010
March 2013   (final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression [ Time Frame: Post intervention and 6 months follow-up ] [ Designated as safety issue: No ]
Hamilton Rating Scale for Depression [ Time Frame: Post intervention and 6 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01065311 on ClinicalTrials.gov Archive Site
  • Beck Depression Inventory II [ Time Frame: Post treatment and 6 months follow-up ] [ Designated as safety issue: No ]
  • Social Adaption Self-evaluation Scale [ Time Frame: Post treatment and 6 months follow-up ] [ Designated as safety issue: No ]
  • Fragebogen zum Gesundheitszustand Kurzform 36 [ Time Frame: Post treatment and 6 months follow-up ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning Scale [ Time Frame: Post treatment and 6 months follow-up ] [ Designated as safety issue: No ]
  • Response Styles Questionnaire [ Time Frame: Post treatment and 6 months follow-up ] [ Designated as safety issue: No ]
  • Beck Depression Inventory II [ Time Frame: Post treatment and 6 month follow-up ] [ Designated as safety issue: No ]
  • Social Adaption Self-evaluation Scale [ Time Frame: Post treatment and 6 month follow-up ] [ Designated as safety issue: No ]
  • Fragebogen zum Gesundheitszustand Kurzform 36 [ Time Frame: Post treatment and 6 month follow-up ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning Scale [ Time Frame: Post treatment and 6 month follow-up ] [ Designated as safety issue: No ]
  • Response Styles Questionnaire [ Time Frame: Post treatment and 6 month follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Mindfulness-based Cognitive Therapy for Chronic Depression
Mindfulness-based Cognitive Therapy for Chronic Depression

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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Major Depression
  • Behavioral: Mindfulness-based Cognitive Therapy
    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
  • Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy
    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.
  • Biological: Standard psychiatric care
    Antidepressant medication and medical care
  • Experimental: Mindfulness-based Cognitive Therapy
    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.
    Interventions:
    • Behavioral: Mindfulness-based Cognitive Therapy
    • Biological: Standard psychiatric care
  • Active Comparator: CBASP
    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.
    Interventions:
    • Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy
    • Biological: Standard psychiatric care
  • Active Comparator: Treatment-as-usual
    Standard psychiatric outpatient care
    Intervention: Biological: Standard psychiatric care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
117
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Johannes Michalak, PD Dr. phil. ++49 234 3227939 Johannes.Michalak@rub.de
Germany
 
NCT01065311
DFG Mi 700/4
No
Johannes Michalak, Ruhr University Bochum
Ruhr University of Bochum
Not Provided
Principal Investigator: Johannes Michalak, PD Dr. phil. Ruhr-University Bochum
Ruhr University of Bochum
July 2011

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