Mindfulness-based Cognitive Therapy for Chronic Depression
This study is currently recruiting participants.
Verified July 2011 by Ruhr University of Bochum
Sponsor:
Ruhr University of Bochum
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
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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
Keywords provided by Ruhr University of Bochum:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
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 October 17, 2012