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Cognitively-Based Compassion Training and Mindfulness Attention Training Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thaddeus Pace, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT01592188
First received: May 2, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This project will explore the effect of Cognitively-Based Compassion Training or mindfulness training on behavior and saliva stress hormones in elementary school-age children.


Condition Intervention Phase
Behavioral Resilience
Biological Resilience
Behavioral: Cognitively-Based Compassion Training (CBCT)
Behavioral: Mindfulness training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Cognitively-Based Compassion Training and Mindfulness Attention Training for Elementary School Students

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Interpersonal behaviors assessed using standardized protocols of social behavior, social cognition, and empathy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in interpersonal behavior. Participants will be asked to respond to questions related to social behavior in the lab setting, with the Social Circle Task, Mind In The Eyes Task, and the Implicit Association Task.

  • Concentrations of stress system biomarkers in saliva [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in stress system activity, as measured by key biomarkers (cortisol, C-reactive protein) in saliva samples.


Enrollment: 53
Study Start Date: January 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MT
Mindfulness training. Participants will be provided with once per week training in mindfulness meditation.
Behavioral: Mindfulness training
Mindfulness training will consist of 6 weeks training in mindfulness meditation.
Other Name: Mindfulness meditation
Experimental: CBCT
Cognitively-based compassion training. Participants in this arm will be provided with once weekly training on the cognitively-based compassion training program.
Behavioral: Cognitively-Based Compassion Training (CBCT)
CBCT is a 12 week program that begins by teaching mindfulness and attention. It then goes on to use new mindfulness skills to consider topics of compassion, or unbiased acceptance and compassion for all other people, both friends, unfamiliar people, and enemies.
Other Name: Compassion Meditation

Detailed Description:

This project will explore the effect of Cognitively-Based Compassion Training (CBCT) or mindfulness training (MT) on different aspects of behavior and stress-related biology in elementary school-age children. The program will consist of 12 weeks of CBCT or MT, and various social behavioral assessments will be conducted. Participants will also provide saliva in which concentrations of stress hormones including cortisol and the inflammatory biomarkers C-reactive protein will be measured.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 7-12
  • enrollment at the Paideia School.

Exclusion Criteria:

  • poor physical health
  • enrollment at a school other than the Paideia school.
  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: NCT01592188

Locations
United States, Georgia
Paideia School
Atlanta, Georgia, United States, 30307
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Philippe Rochat, PhD Emory University
Principal Investigator: Thaddeus Pace, PhD Emory University
  More Information

No publications provided

Responsible Party: Thaddeus Pace, PhD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01592188     History of Changes
Other Study ID Numbers: IRB00054782, CBCT-Paideia
Study First Received: May 2, 2012
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
meditation, inflammation, children, attention

ClinicalTrials.gov processed this record on November 25, 2014