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

NCT ID: NCT01643369

Last Updated: 2014-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Compassion Meditation Group

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

Group Type: EXPERIMENTAL

Cognitive-Based Compassion Training

Intervention Type: BEHAVIORAL

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

Health Education and Wellness Group

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

Group Type: ACTIVE_COMPARATOR

Adult Health Education Curriculum

Intervention Type: BEHAVIORAL

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

Mindful Attention Training

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

Group Type: EXPERIMENTAL

Mindful Attention Training

Intervention Type: BEHAVIORAL

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

Interventions

Cognitive-Based Compassion Training

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

Intervention Type: BEHAVIORAL

Adult Health Education Curriculum

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

Intervention Type: BEHAVIORAL

Mindful Attention Training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Raison, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

12-0123-02

Identifier Type: -

Identifier Source: org_study_id