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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale Change with MBCT treatment | 17-item clinician-rated measure of depression severity. | Week 0, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein (Blood) Change with MBCT treatment | An inflammatory biomarker that varies with levels of inflammation in the body | Week 0-8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness-based cognitive therapy, depression, treatment, mindfulness meditation, psychotherapy