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Mindfulness-based Cognitive Therapy for Chronic Depression

Sponsor
Johannes Michalak (Other)
Overall Status
Completed
CT.gov ID
NCT01065311
Collaborator
(none)
106
Enrollment
1
Location
3
Arms
31
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-based Cognitive Therapy
  • Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy
  • Biological: Standard psychiatric care
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mindfulness-based Cognitive Therapy for Chronic Depression
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

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

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

    		•
    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.

    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

    		•
    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

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hamilton Rating Scale for Depression [Change from Baseline in HAM-D at 8 weeks]

    Secondary Outcome Measures

    1. Beck Depression Inventory II [Change from Baseline in BDI-II at 8 weeks]

    2. Social Adaption Self-evaluation Scale [Change from Baseline in SASS at 8 weeks]

    3. Short Form (36) Health Survey [Change from Baseline in SF-36 at 8 weeks]

    4. Global Assessment of Functioning Scale [Change from Baseline in HAM-D at 8 weeks]

    5. Response Styles Questionnaire [Change from Baseline in RSQ at 8 weeks]

    6. Beck Depression Inventory II [Change from Baseline in BDI-II at 6 months]

    7. Social Adaption Self-evaluation Scale [Change from Baseline in SASS at 6 months]

    8. Short Form (36) Health Survey [Change from Baseline in SF-36 at 6 months]

    9. Global Assessment of Functioning Scale [Change from Baseline in GAF at 6 months]

    10. Response Styles Questionnaire [Change from Baseline in RSQ at 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Hildesheim Hildesheim Germany 31141

    Sponsors and Collaborators

    • Johannes Michalak

    Investigators

    • Principal Investigator: Johannes Michalak, PD Dr. phil., University of Hildesheim

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johannes Michalak, Prof. Dr. phil., Ruhr University of Bochum
    ClinicalTrials.gov Identifier:
    NCT01065311
    Other Study ID Numbers:
    • DFG Mi 700/4
    First Posted:
    Feb 9, 2010
    Last Update Posted:
    May 15, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Johannes Michalak, Prof. Dr. phil., Ruhr University of Bochum
    Depressive Disorder
    Psychotherapy
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of May 15, 2014