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Mindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02385786
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):
Stuart Eisendrath, University of California, San Francisco

Brief Summary:
This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from baseline to completion of treatment at 8 weeks in terms of depression severity using the Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of inflammation, over the same time period.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Mindfulness-Based Cognitive Therapy Not Applicable

Detailed Description:

This study will investigate the effectiveness of MBCT as a primary treatment for MDD. Twelve unmedicated subjects with MDD were enrolled in the study. All subjects with MDD underwent depression severity assessment at baseline and after the 8-week intervention was complete to measure change. In addition, the subjects underwent blood sampling at the same time points to measure C-Reactive Protein change over the 8 weeks.

The primary goal of this pilot study is to determine the efficacy of MBCT as a primary treatment for adults with MDD. We will also measure change in the inflammatory biomarker C-Reactive Protein for an examination of the effects of depression treatment on this measure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Cognitive Therapy Depression Efficacy and Effects on Inflammatory Biomarker Levels
Study Start Date : November 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mindfulness-Based Cognitive Therapy
Adult Participants with Major Depressive Disorder who Enroll in an open clinical trial of MBCT as Mono-therapy
Behavioral: Mindfulness-Based Cognitive Therapy
Eight week course in mindfulness meditation training with elements of cognitive behavioral therapy

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale Change with MBCT treatment [ Time Frame: Week 0, 8 ]
    17-item clinician-rated measure of depression severity.

Secondary Outcome Measures :
  1. C-Reactive Protein (Blood) Change with MBCT treatment [ Time Frame: Week 0-8 ]
    An inflammatory biomarker that varies with levels of inflammation in the body

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • English speaking
  • Able to give informed consent
  • DSM-IV (SCID) Diagnosis of Major Depression
  • HAM-D17 score ≥ 17
  • Good general medical health; no active significant uncontrolled medical illness
  • Free of antidepressant medication for a minimum of 6 weeks before study entry
  • Not "needle phobic" by self report

Exclusion Criteria:

  • Axis I and II disorders including: Bipolar, Obsessive Compulsive Disorder, Psychosis, or Antisocial or Borderline Personality Disorder with suicidal risk
  • Major Depression with Psychotic Features
  • Actively suicidal
  • Recent (6 month) history of substance or alcohol dependence (DSM-IV criteria)
  • Meditation practice once or more per week
  • Yoga practice more than twice per week at study entry
  • Mini Mental Status Exam score < 25or history of neurologic illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02385786

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Stuart Eisendrath, MD University of California, San Francisco

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Responsible Party: Stuart Eisendrath, M.D., Principal Investigator, University of California, San Francisco Identifier: NCT02385786     History of Changes
Other Study ID Numbers: 11-07162
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by Stuart Eisendrath, University of California, San Francisco:
mindfulness-based cognitive therapy
mindfulness meditation
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders