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

Major Depressive Disorder Clinical Trial

Official title:

Mindfulness-Based Cognitive Therapy Depression Efficacy and Effects on Inflammatory Biomarker Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385786
• Other study ID #: 11-07162
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Mindfulness-Based Cognitive Therapy
Eight week course in mindfulness meditation training with elements of cognitive behavioral therapy

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale Change with MBCT treatment	17-item clinician-rated measure of depression severity.	Week 0, 8
Secondary	C-Reactive Protein (Blood) Change with MBCT treatment	An inflammatory biomarker that varies with levels of inflammation in the body	Week 0-8