Mindfulness-based Cognitive Therapy for Chronic Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ruhr University of Bochum.
Recruitment status was  Recruiting
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
  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

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression [ Time Frame: Post intervention and 6 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 117
Study Start Date: October 2010
Estimated Study Completion Date: March 2013
Estimated 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
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
Active Comparator: Treatment-as-usual
Standard psychiatric outpatient care
Biological: Standard psychiatric care
Antidepressant medication and medical care

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

Contacts
Contact: Johannes Michalak, PD Dr. phil. ++49 234 3227939 Johannes.Michalak@rub.de

Locations
Germany
Ruhr-University Recruiting
Bochum, Germany, 44780
Contact: Johannes Michalak, Prof. Dr. phil.         
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
Principal Investigator: Johannes Michalak, PD Dr. phil. Ruhr-University Bochum
  More Information

No publications provided

Responsible Party: Johannes Michalak, Ruhr University Bochum
ClinicalTrials.gov Identifier: NCT01065311     History of Changes
Other Study ID Numbers: DFG Mi 700/4
Study First Received: February 8, 2010
Last Updated: July 20, 2011
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
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014