Clinical trial NCT02385786: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: mindfulness-based cognitive therapy
depression
treatment
mindfulness meditation
psychotherapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Rating Scale Change with MBCT treatment
timeFrame: Week 0, 8
Secondary outcomes:
measure: C-Reactive Protein (Blood) Change with MBCT treatment
timeFrame: Week 0-8
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stuart Eisendrath, MD
role: PRINCIPAL_INVESTIGATOR
References: