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Immune System ProcessesNCT01643369

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

A study testing Cognitive-Based Compassion Training, Adult Health Education Curriculum and Mindful Attention Training in people with Immune System Processes and Inflammatory Activation and Modulation, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 55 yearsHealthy volunteers can take part
What is being tested?
Cognitive-Based Compassion Training, Adult Health Education Curriculum and Mindful Attention Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Nov 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Arizona

    Tucson, Arizona, 85724

Other trials in United States

About this study

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.

Being tested
Cognitive-Based Compassion Training, Adult Health Education Curriculum, Mindful Attention Training
Keywords
meditation, compassion, inflammation, immune system
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Based Compassion TrainingBehavioural

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

  • Adult Health Education CurriculumBehavioural

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

  • Mindful Attention TrainingBehavioural

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

Study groups in NCT01643369
Study groupRoleWhat they receive
Compassion Meditation GroupExperimentalEight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University
Receives: Behavioral: Cognitive-Based Compassion Training
Health Education and Wellness GroupActive comparatorEight week training in health and wellness, using a curriculum developed specifically for this study.
Receives: Behavioral: Adult Health Education Curriculum
Mindful Attention TrainingExperimentalEight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.
Receives: Behavioral: Mindful Attention Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01643369
Sponsor's protocol ID
12-0123-02
Status last verified
Dec 2014
First submitted
16 Jul 2012
Last updated
8 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Based Compassion Training, Adult Health Education Curriculum and Mindful Attention Training in people with Immune System Processes and Inflammatory Activation and Modulation, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objectively-assessed, real-world, prosocial and affiliative behavior (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.

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