The Compassion and Attention Longitudinal Meditation Study (CALM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Arizona
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01251341
First received: November 30, 2010
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Immune System Processes
Inflammatory Activation and Modulation
ANS Function
Behavioral: Cognitive-Based Compassion Training
Behavioral: Mindful Attention Training
Behavioral: Adult Health Education Curriculum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanisms of Meditation

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 385
Study Start Date: September 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compassion Meditation Group Behavioral: Cognitive-Based Compassion Training
Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University
Active Comparator: Health Education and Wellness Group Behavioral: Adult Health Education Curriculum
Eight week training in health and wellness, using a curriculum developed specifically for this study.
Experimental: Mindful Attention Training Behavioral: Mindful Attention Training
Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251341

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Thaddeus W. Pace, MD    404-778-3965    twpace@emory.edu   
Principal Investigator: Charles L. Raison, MD         
Sponsors and Collaborators
University of Arizona
Emory University
Investigators
Principal Investigator: Charles Raison, MD University of Arizona
Study Director: Lobsang Tenzin Negi, PhD Emory University
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01251341     History of Changes
Other Study ID Numbers: 5R01AT004698
Study First Received: November 30, 2010
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
inflammation
immune system
cytokines
meditation
compassion
attention

ClinicalTrials.gov processed this record on July 31, 2014