The Compassion and Attention Longitudinal Meditation Study (CALM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251341
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : December 5, 2014
Emory University
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
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 or disease Intervention/treatment Phase
Immune System Processes Inflammatory Activation and Modulation ANS Function Behavioral: Cognitive-Based Compassion Training Behavioral: Mindful Attention Training Behavioral: Adult Health Education Curriculum Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mechanisms of Meditation
Study Start Date : September 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Effects of compassion meditation on inflammatory and behavioral responses to psychosocial stress using a longitudinal design. [ Time Frame: Five years ]
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251341

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
University of Arizona
Emory University
Principal Investigator: Charles Raison, MD University of Arizona
Study Director: Lobsang Tenzin Negi, PhD Emory University

Responsible Party: University of Arizona Identifier: NCT01251341     History of Changes
Other Study ID Numbers: 5R01AT004698 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University of Arizona:
immune system