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

December 5, 2014 updated by: University of Arizona
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compassion Meditation Group
Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University
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
Eight week training in health and wellness, using a curriculum developed specifically for this study.
Eight week training in health and wellness, using a curriculum developed specifically for this study.
Experimental: Mindful Attention Training
Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.
Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objectively-assessed, real-world, prosocial and affiliative behavior
Time Frame: 8 months
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.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Charles Raison, MD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 16, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 12-0123-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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