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CompletedNCT01643369Updated Dec 8, 2014

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

An interventional study of Cognitive-Based Compassion Training and Adult Health Education Curriculum in Immune System Processes, Inflammatory Activation and Modulation and ANS Function, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-08.

Sponsored by University of Arizona · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Immune System Processes
  • Inflammatory Activation and Modulation
  • ANS Function

Keywords

  • meditation
  • compassion
  • inflammation
  • immune system
03

In context

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Compassion Meditation Group

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

    Behavioral: Cognitive-Based Compassion Training

  • Active comparator
    Health Education and Wellness Group

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

    Behavioral: Adult Health Education Curriculum

  • Experimental
    Mindful Attention Training

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

    Behavioral: Mindful Attention Training

Interventions

  • BehavioralCognitive-Based Compassion Training

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

  • BehavioralAdult Health Education Curriculum

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

  • BehavioralMindful Attention Training

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

06

What researchers measure

Primary outcomes

  1. Objectively-assessed, real-world, prosocial and affiliative behavior

    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.

    Time frame: 8 months

07

Study locations

1 site
  • University of Arizona
    Tucson, Arizona 85724, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01643369
Lead sponsor
University of Arizona
Responsible party
Sponsor
First posted
Jul 18, 2012
Start date
Nov 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Dec 8, 2014

Study contacts

Charles Raison, MD
principal investigator · University of Arizona

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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