Mindfulness-Based Cognitive Therapy Effect on Depression and C-Reactive Protein Levels After 8 Weeks of Treatment
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Nov 2011
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedMarch 22, 2022
March 1, 2022
9 months
March 2, 2015
March 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale Change with MBCT treatment
17-item clinician-rated measure of depression severity.
Week 0, 8
Secondary Outcomes (1)
C-Reactive Protein (Blood) Change with MBCT treatment
Week 0-8
Study Arms (1)
Mindfulness-Based Cognitive Therapy
EXPERIMENTALAdult Participants with Major Depressive Disorder who Enroll in an open clinical trial of MBCT as Mono-therapy
Interventions
Eight week course in mindfulness meditation training with elements of cognitive behavioral therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart Eisendrath, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 11, 2015
Study Start
November 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
March 22, 2022
Record last verified: 2022-03