Mindfulness-based Cognitive Therapy for Chronic Depression

May 14, 2014 updated by: Johannes Michalak
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hildesheim, Germany, 31141
        • University of Hildesheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Rating Scale for Depression
Time Frame: Change from Baseline in HAM-D at 8 weeks
Change from Baseline in HAM-D at 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory II
Time Frame: Change from Baseline in BDI-II at 8 weeks
Change from Baseline in BDI-II at 8 weeks
Social Adaption Self-evaluation Scale
Time Frame: Change from Baseline in SASS at 8 weeks
Change from Baseline in SASS at 8 weeks
Short Form (36) Health Survey
Time Frame: Change from Baseline in SF-36 at 8 weeks
Change from Baseline in SF-36 at 8 weeks
Global Assessment of Functioning Scale
Time Frame: Change from Baseline in HAM-D at 8 weeks
Change from Baseline in HAM-D at 8 weeks
Response Styles Questionnaire
Time Frame: Change from Baseline in RSQ at 8 weeks
Change from Baseline in RSQ at 8 weeks
Beck Depression Inventory II
Time Frame: Change from Baseline in BDI-II at 6 months
Change from Baseline in BDI-II at 6 months
Social Adaption Self-evaluation Scale
Time Frame: Change from Baseline in SASS at 6 months
Change from Baseline in SASS at 6 months
Short Form (36) Health Survey
Time Frame: Change from Baseline in SF-36 at 6 months
Change from Baseline in SF-36 at 6 months
Global Assessment of Functioning Scale
Time Frame: Change from Baseline in GAF at 6 months
Change from Baseline in GAF at 6 months
Response Styles Questionnaire
Time Frame: Change from Baseline in RSQ at 6 months
Change from Baseline in RSQ at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Michalak

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFG Mi 700/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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