The Sounds of Compassion: Testing How Specific Elements of Meditation Change Daily Life

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01643369
First received: July 16, 2012
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

Important health benefits of meditation may be conferred as much by what people actually do and say in their daily lives as by how they self-perceive the effect of training on their behavior and emotions. To test this hypothesis, and to explore whether specific elements of meditation (e.g. compassion vs. mindfulness) have different effects on real-world social behavior, the current project proposes to use the Electronically Activated Recorder (EAR) in a randomized, longitudinal design to objectively measure whether meditation does indeed make people behave in happier, kinder and more prosocial ways in their daily lives. This design will permit an exploratory analysis of how such behavioral transformations might relate to subjective reports of meditative effects. To accomplish these objectives, 108 medically healthy adults will be randomized to 8 weeks training in compassion meditation (n=36), Mindfulness Attention Training (MAT) (n = 36) or to an active control condition consisting of a health education discussion group (n=36). Prior to randomization and again upon completion of these interventions, all subjects will participate in an EAR protocol to evaluate the effect of meditation training on their real-world prosocial and affiliative behavior. Based on prior research and direct pilot data from 25 participants, prosocial and affiliative behavior will be assessed as the amount of (1) shown empathy and affection, (2) laughing vs. sighing, (3) arguing and complaining, (4) time spent interacting with others vs. alone, (5) meaningful conversations, (6) socially inclusive (i.e. use of "we"/us") vs. self-focused (i.e. use of "I"/me") first person language. Following the first EAR assessment, subjects will commence 8 weeks of compassion meditation training, MAT, or attendance in the health discussion group. Following these interventions subjects will participate in EAR monitoring identical to the initial assessment. To assess whether changes in daily behavior are sustained over a longer period, all subjects will undergo a final EAR assessment 6 months following completion of the study interventions. Self-report measures of social integration and support and behavioral/lifestyle variables that might be associated with EAR outcomes will be evaluated prior to each EAR assessment and treated as covariates.


Condition Intervention
Immune System Processes
Inflammatory Activation and Modulation
ANS Function
Behavioral: Cognitive-Based Compassion Training
Behavioral: Adult Health Education Curriculum
Behavioral: Mindful Attention Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Sounds of Compassion: Testing How Specific Elements of Meditation Change Daily Life

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Objectively-assessed, real-world, prosocial and affiliative behavior [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Subjects will participate in 8 weeks of compassion meditation training, MAT, or attendance in the health discussion group. Electronically Activated Recorder (EAR) protocol will be used to evaluate the effect of meditation training on their real-world prosocial and affiliative behavior.


Estimated Enrollment: 108
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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
Criteria

Inclusion Criteria:

  • Males and females between the ages of 25 - 55 at study entry
  • Ambulatory and in good medical health (see exclusion criteria below for specifics)
  • Ability to read/understand English

Exclusion Criteria: Potential subjects will be excluded for any serious ongoing medical or psychiatric condition that might influence results or increase risk of stated participation, including but not limited to:

  • Malignancy
  • Auto-immune disorder
  • Neurologic disorder
  • Endocrinopathy; chronic infection (i.e. human immunodeficiency virus, hepatitis B or C)
  • Any renal, hepatic or hematological abnormality (other than history of mild anemia)
  • Current major depression or major depression requiring hospitalization or resulting in suicide attempt in past year
  • Current active suicidal ideation as assessed by the Structured Clinical Interview for DSM-IV (SCID): current DSM-IV substance abuse
  • Schizophrenia or bipolar disorder type 1
  • BMI ≥ 30
  • Any other current/past condition that might increase the risk of participation.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643369

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Charles Raison, MD University of Arizona
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01643369     History of Changes
Other Study ID Numbers: 12-0123-02
Study First Received: July 16, 2012
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
meditation
compassion
inflammation
immune system

ClinicalTrials.gov processed this record on October 19, 2014