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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Mindfulness-Based Cognitive Therapy

• Registration Number: NCT02385786
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Cognitive Therapy	Mindfulness-Based Cognitive Therapy	Adult Participants with Major Depressive Disorder who Enroll in an open clinical trial of MBCT as Mono-therapy

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale Change with MBCT treatment	Week 0, 8	17-item clinician-rated measure of depression severity.

Secondary Outcome Measures

Name	Time	Method
C-Reactive Protein (Blood) Change with MBCT treatment	Week 0-8	An inflammatory biomarker that varies with levels of inflammation in the body

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States