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

NCT ID: NCT02385786

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-08-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based Cognitive Therapy

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

Group Type: EXPERIMENTAL

Mindfulness-Based Cognitive Therapy

Intervention Type: BEHAVIORAL

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

Interventions

Mindfulness-Based Cognitive Therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Eisendrath, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

11-07162

Identifier Type: -

Identifier Source: org_study_id