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The Compassion and Attention Longitudinal Meditation Study (CALM)

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University of Arizona

Status

Completed

Conditions

Immune System Processes
Inflammatory Activation and Modulation
ANS Function

Treatments

Behavioral: Cognitive-Based Compassion Training
Behavioral: Mindful Attention Training
Behavioral: Adult Health Education Curriculum

Study type

Interventional

Funder types

Other

Identifiers

NCT01251341
5R01AT004698

Details and patient eligibility

About

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.

Enrollment

226 patients

Sex

All

Ages

25 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

226 participants in 3 patient groups

Compassion Meditation Group
Experimental group
Treatment:
Behavioral: Cognitive-Based Compassion Training
Health Education and Wellness Group
Active Comparator group
Treatment:
Behavioral: Adult Health Education Curriculum
Mindful Attention Training
Experimental group
Treatment:
Behavioral: Mindful Attention Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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