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

University of California, San Francisco43 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Mindfulness-Based Cognitive TherapyBEHAVIORAL

Eight week course in mindfulness meditation training with elements of cognitive behavioral therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale Change with MBCT treatment

17-item clinician-rated measure of depression severity.

Time frame: Week 0, 8

Secondary Outcomes

C-Reactive Protein (Blood) Change with MBCT treatment

An inflammatory biomarker that varies with levels of inflammation in the body

Time frame: Week 0-8

Data from ClinicalTrials.gov

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