The Compassion and Attention Longitudinal Meditation Study (CALM)

This study is currently recruiting participants.
Verified November 2012 by University of Arizona
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Charles (Chuck) Raison, University of Arizona
ClinicalTrials.gov Identifier:
NCT01251341
First received: November 30, 2010
Last updated: November 26, 2012
Last verified: November 2012

November 30, 2010
November 26, 2012
September 2009
December 2014   (final data collection date for primary outcome measure)
Effects of compassion meditation on inflammatory and behavioral responses to psychosocial stress using a longitudinal design. [ Time Frame: Five years ] [ Designated as safety issue: No ]
Innate immune cytokine responses will be assessed before and after a psychosocial stressor to evaluate the differential impact of the two interventions and the active control.
Same as current
Complete list of historical versions of study NCT01251341 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Compassion and Attention Longitudinal Meditation Study
Mechanisms of Meditation

The increasingly widespread use of meditation for stress-related emotional and medical conditions highlights the urgent need to rigorously evaluate mechanisms through which the benefits of practice might be conferred. Primary challenges in this regard include evaluating dose response relationships between practice time and outcomes; clarifying whether physiological and behavioral effects of meditation derive primarily from non-specific aspects of training or result from specific meditation practices; and identifying molecular mechanisms by which meditation might affect physiological responses relevant to stress-related illness. Recent findings from a cross-sectional study by our group indicate that young adults who are randomized to, and practice, compassion meditation demonstrate reduced inflammatory responses, less emotional distress, and reduced autonomic responses to a standardized laboratory psychosocial stressor (Trier Social Stress Test [TSST]) when compared to subjects randomized to an active control condition. However, as a result of the cross-sectional study design and lack of a meditation comparator arm, these results provide only partial insight into key issues outlined above regarding the role played by specific meditation procedures and/or practice time in observed physiological and behavioral outcomes. The primary hypothesis of the proposed work is that practicing a meditation procedure specifically designed to enhance empathic concern for others (i.e. compassion meditation) will optimize autonomic reactivity to psychosocial stress in a manner that results in diminished activation of peripheral inflammatory signaling pathways and reduced behavioral distress.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Immune System Processes
  • Inflammatory Activation and Modulation
  • ANS Function
  • Behavioral: Cognitive-Based Compassion Training
    Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University
  • Behavioral: Mindful Attention Training
    Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.
  • Behavioral: Adult Health Education Curriculum
    Eight week training in health and wellness, using a curriculum developed specifically for this study.
  • Experimental: Compassion Meditation Group
    Intervention: Behavioral: Cognitive-Based Compassion Training
  • Active Comparator: Health Education and Wellness Group
    Intervention: Behavioral: Adult Health Education Curriculum
  • Experimental: Mindful Attention Training
    Intervention: Behavioral: Mindful Attention Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
385
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Good medical health

Exclusion Criteria:

  • current major depression
  • current substance abuse
  • lifetime history of schizophrenia or bipolar disorder type I as assessed by the Structured Diagnostic Interview for DSM-IV (SCID)
  • suicidal ideation or suicide attempt within one year of study enrollment
  • diagnosis of any serious ongoing medical condition including malignancy, auto-immune disease (i.e. rheumatoid arthritis, multiple sclerosis, Crohn's disease), cardiovascular disease (other than hypertension), seizure disorder, endocrinopathy, chronic infection (i.e. human immunodeficiency virus, hepatitis B or C), renal or hepatic insufficiency, or any other current or past medical or psychiatric condition that might increase the risk of study participation in the opinion of study personnel
  • treatment with psychotropic medications within the last year (i.e. antidepressants, anxiolytics, psychostimulants or mood stabilizers)
  • active ongoing psychiatric treatment at the time of enrollment.
  • use of any psychotropic medication (i.e. antidepressants, anxiolytics, psychostimulants or mood stabilizers) within one year of screening.
  • chronic use of anti-inflammatory/immunosuppressive agents, including, but not limited to, aspirin, non-steroidal anti-inflammatory agents, COX-2 inhibitors, corticosteroids, etanercept, infliximab, adalimumab or methotrexate.
  • any significant past meditation training/experience (defined as meditating more than 3 times a week for a period longer than a month)
Both
25 Years to 55 Years
Yes
Not Provided
United States
 
NCT01251341
5R01AT004698
Yes
Charles (Chuck) Raison, University of Arizona
University of Arizona
Emory University
Not Provided
University of Arizona
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP