The Compassion and Attention Longitudinal Meditation Study

NCT01251341 | Completed DMC

• 1 other identifier: 5R01AT004698
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Effects of compassion meditation on inflammatory and behavioral responses to psychosocial stress using a longitudinal design.

  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.

  Five years

Study Arms (3)

Compassion Meditation Group

EXPERIMENTAL

Behavioral: Cognitive-Based Compassion Training

Health Education and Wellness Group

ACTIVE COMPARATOR

Behavioral: Adult Health Education Curriculum

Mindful Attention Training

EXPERIMENTAL

Behavioral: Mindful Attention Training

Interventions

Cognitive-Based Compassion Training BEHAVIORAL

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

Compassion Meditation Group

Mindful Attention Training BEHAVIORAL

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

Mindful Attention Training

Adult Health Education Curriculum BEHAVIORAL

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

Health Education and Wellness Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good medical health

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead
• Emory University: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Raison, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Lobsang Tenzin Negi, PhD

  Emory University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 1, 2010
• Study Start: September 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

US (1)