The Compassion and Attention Longitudinal Meditation Study

NCT ID: NCT01251341

Last Updated: 2014-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-05-31

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.

Conditions

Immune System Processes; Inflammatory Activation and Modulation; ANS Function

Keywords

inflammation; immune system; cytokines; meditation; compassion; attention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Compassion Meditation Group

Group Type: EXPERIMENTAL

Cognitive-Based Compassion Training

Intervention Type: BEHAVIORAL

Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University

Health Education and Wellness Group

Group Type: ACTIVE_COMPARATOR

Adult Health Education Curriculum

Intervention Type: BEHAVIORAL

Eight week training in health and wellness, using a curriculum developed specifically for this study.

Mindful Attention Training

Group Type: EXPERIMENTAL

Mindful Attention Training

Intervention Type: BEHAVIORAL

Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.

Interventions

Cognitive-Based Compassion Training

Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University

Intervention Type: BEHAVIORAL

Mindful Attention Training

Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.

Intervention Type: BEHAVIORAL

Adult Health Education Curriculum

Eight week training in health and wellness, using a curriculum developed specifically for this study.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Raison, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Lobsang Tenzin Negi, PhD

Role: STUDY_DIRECTOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

5R01AT004698

Identifier Type: NIH

Identifier Source: org_study_id

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