Mindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment
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|ClinicalTrials.gov Identifier: NCT02385786|
Recruitment Status : Completed
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Mindfulness-Based Cognitive Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Hamilton Depression Rating Scale Change with MBCT treatment [ Time Frame: Week 0, 8 ]17-item clinician-rated measure of depression severity.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02385786
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Stuart Eisendrath, MD||University of California, San Francisco|