The Compassion and Attention Longitudinal Meditation Study (CALM)
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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 |
- 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 |
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| 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 | |
More Information
No publications provided
| Responsible Party: | Charles (Chuck) Raison, Associate Professor, University of Arizona |
| ClinicalTrials.gov Identifier: | NCT01251341 History of Changes |
| Other Study ID Numbers: | 5R01AT004698 |
| Study First Received: | November 30, 2010 |
| Last Updated: | November 26, 2012 |
| 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 May 16, 2013