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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Mindfulness-Based Cognitive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02385786

11-07162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 1 patient group

Mindfulness-Based Cognitive Therapy

Experimental group

Description:

Adult Participants with Major Depressive Disorder who Enroll in an open clinical trial of MBCT as Mono-therapy

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy