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
  Purpose

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 Intervention Phase
Chronic Major Depression
Behavioral: Mindfulness-based Cognitive Therapy
Behavioral: The Cognitive Behavioral Analysis System of Psychotherapy
Biological: Standard psychiatric care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based Cognitive Therapy for Chronic Depression

Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Change from Baseline in HAM-D at 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 106
Study Start Date: October 2010
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065311

Locations
Germany
University of Hildesheim
Hildesheim, Germany, 31141
Sponsors and Collaborators
Johannes Michalak
Investigators
Principal Investigator: Johannes Michalak, PD Dr. phil. University of Hildesheim
  More Information

No publications provided

Responsible Party: Johannes Michalak, Prof. Dr. phil., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01065311     History of Changes
Other Study ID Numbers: DFG Mi 700/4
Study First Received: February 8, 2010
Last Updated: May 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
Depressive Disorder
Psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014