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CompletedNCT02385786Updated Mar 22, 2022

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

An interventional study of Mindfulness-Based Cognitive Therapy in Major Depressive Disorder, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-22.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • mindfulness-based cognitive therapy
  • depression
  • treatment
  • mindfulness meditation
  • psychotherapy
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 43 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Mindfulness-Based Cognitive Therapy

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

    Behavioral: Mindfulness-Based Cognitive Therapy

Interventions

  • BehavioralMindfulness-Based Cognitive Therapy

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

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What researchers measure

Primary outcomes

  1. Hamilton Depression Rating Scale Change with MBCT treatment

    17-item clinician-rated measure of depression severity.

    Time frame: Week 0, 8

Secondary outcomes

  1. C-Reactive Protein (Blood) Change with MBCT treatment

    An inflammatory biomarker that varies with levels of inflammation in the body

    Time frame: Week 0-8

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Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94143, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02385786
Lead sponsor
University of California, San Francisco
Responsible party
Sponsor
First posted
Mar 11, 2015
Start date
Nov 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Mar 22, 2022

Study contacts

Stuart Eisendrath, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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