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Completed

NCT Number: NCT02385786

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Cognitive Therapy

Behavioral

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

Primary outcomes

  1. Hamilton Depression Rating Scale Change with MBCT treatment

    Time frame: Week 0, 8

    17-item clinician-rated measure of depression severity.

Secondary outcomes

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

    Time frame: Week 0-8

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Mindfulness-Based Cognitive Therapy Depression Efficacy and Effects on Inflammatory Biomarker Levels

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 11, 2015
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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