Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Mindfulness-based Cognitive Therapy for Chronic Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johannes Michalak, Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT01065311
First received: February 8, 2010
Last updated: May 14, 2014
Last verified: May 2014

February 8, 2010
May 14, 2014
October 2010
March 2013   (final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression [ Time Frame: Change from Baseline in HAM-D at 8 weeks ] [ 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: Change from Baseline in BDI-II at 8 weeks ] [ Designated as safety issue: No ]
  • Social Adaption Self-evaluation Scale [ Time Frame: Change from Baseline in SASS at 8 weeks ] [ Designated as safety issue: No ]
  • Short Form (36) Health Survey [ Time Frame: Change from Baseline in SF-36 at 8 weeks ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning Scale [ Time Frame: Change from Baseline in HAM-D at 8 weeks ] [ Designated as safety issue: No ]
  • Response Styles Questionnaire [ Time Frame: Change from Baseline in RSQ at 8 weeks ] [ Designated as safety issue: No ]
  • Beck Depression Inventory II [ Time Frame: Change from Baseline in BDI-II at 6 months ] [ Designated as safety issue: No ]
  • Social Adaption Self-evaluation Scale [ Time Frame: Change from Baseline in SASS at 6 months ] [ Designated as safety issue: No ]
  • Short Form (36) Health Survey [ Time Frame: Change from Baseline in SF-36 at 6 months ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning Scale [ Time Frame: Change from Baseline in GAF at 6 months ] [ Designated as safety issue: No ]
  • Response Styles Questionnaire [ Time Frame: Change from Baseline in RSQ at 6 months ] [ 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).

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.

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.

    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

    Other Names:
    • Psychiatric care
    • neurologic care
    • ambulant setting
  • 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:

    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: 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.
 
Completed
106
May 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 information is only displayed when the study is recruiting subjects
Germany
 
NCT01065311
DFG Mi 700/4
No
Johannes Michalak, Ruhr University of Bochum
Johannes Michalak
Not Provided
Principal Investigator: Johannes Michalak, PD Dr. phil. University of Hildesheim
Ruhr University of Bochum
May 2014

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