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

NCT01643369 | Completed DMC

• 1 other identifier: 12-0123-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune System Processes; Inflammatory Activation and Modulation; ANS Function

Keywords

meditation; compassion; inflammation; immune system

Outcome Measures

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.

  8 months

Study Arms (3)

Compassion Meditation Group

EXPERIMENTAL

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

Behavioral: Cognitive-Based Compassion Training

Health Education and Wellness Group

ACTIVE COMPARATOR

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

Behavioral: Adult Health Education Curriculum

Mindful Attention Training

EXPERIMENTAL

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

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

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

Mindful Attention Training BEHAVIORAL

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

Mindful Attention Training

Eligibility Criteria

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

You may qualify if:

• Males and females between the ages of 25 - 55 at study entry

You may not qualify if:

• Ability to read/understand English
• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, 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

Study Design

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

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 8, 2014

Record last verified: 2014-12

Locations

US (1)