Back to resultsMindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring mindfulness-based cognitive therapy, depression, treatment, mindfulness meditation, psychotherapy
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
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mindfulness-Based Cognitive Therapy
Arm Description
Adult Participants with Major Depressive Disorder who Enroll in an open clinical trial of MBCT as Mono-therapy
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale Change with MBCT treatment
17-item clinician-rated measure of depression severity.
Secondary Outcome Measures
C-Reactive Protein (Blood) Change with MBCT treatment
An inflammatory biomarker that varies with levels of inflammation in the body
Full Information
NCT ID
NCT02385786
First Posted
March 2, 2015
Last Updated
March 7, 2022
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02385786
Brief Title
Mindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment
Official Title
Mindfulness-Based Cognitive Therapy Depression Efficacy and Effects on Inflammatory Biomarker Levels
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
mindfulness-based cognitive therapy, depression, treatment, mindfulness meditation, psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Cognitive Therapy
Arm Type
Experimental
Arm Description
Adult Participants with Major Depressive Disorder who Enroll in an open clinical trial of MBCT as Mono-therapy
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy
Intervention Description
Eight week course in mindfulness meditation training with elements of cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale Change with MBCT treatment
Description
17-item clinician-rated measure of depression severity.
Time Frame
Week 0, 8
Secondary Outcome Measure Information:
Title
C-Reactive Protein (Blood) Change with MBCT treatment
Description
An inflammatory biomarker that varies with levels of inflammation in the body
Time Frame
Week 0-8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Eisendrath, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment
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