Immune System ProcessesCALMNCT01251341
The Compassion and Attention Longitudinal Meditation Study
A study testing Cognitive-Based Compassion Training, Mindful Attention Training and Adult Health Education Curriculum in people with Immune System Processes and Inflammatory Activation and Modulation, run by University of Arizona at 1 site in United States.
Trial summary
The increasingly widespread use of meditation for stress-related emotional and medical conditions highlights the urgent need to rigorously evaluate mechanisms through which the benefits of practice might be conferred. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Processes, Inflammatory Activation and Modulation, ANS Function
- What is being tested?
- Cognitive-Based Compassion Training, Mindful Attention Training and Adult Health Education Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to May 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
- Good medical health
Who cannot join
- current major depression
- current substance abuse
- lifetime history of schizophrenia or bipolar disorder type I as assessed by the Structured Diagnostic Interview for DSM-IV (SCID)
- suicidal ideation or suicide attempt within one year of study enrollment
- diagnosis of any serious ongoing medical condition including malignancy, auto-immune disease (i.e. rheumatoid arthritis, multiple sclerosis, Crohn's disease), cardiovascular disease (other than hypertension), seizure disorder, endocrinopathy, chronic infection (i.e. human immunodeficiency virus, hepatitis B or C), renal or hepatic insufficiency, or any other current or past medical or psychiatric condition that might increase the risk of study participation in the opinion of study personnel
- treatment with psychotropic medications within the last year (i.e. antidepressants, anxiolytics, psychostimulants or mood stabilizers)
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- active ongoing psychiatric treatment at the time of enrollment.
- use of any psychotropic medication (i.e. antidepressants, anxiolytics, psychostimulants or mood stabilizers) within one year of screening.
- chronic use of anti-inflammatory/immunosuppressive agents, including, but not limited to, aspirin, non-steroidal anti-inflammatory agents, COX-2 inhibitors, corticosteroids, etanercept, infliximab, adalimumab or methotrexate.
- any significant past meditation training/experience (defined as meditating more than 3 times a week for a period longer than a month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Meditation
The increasingly widespread use of meditation for stress-related emotional and medical conditions highlights the urgent need to rigorously evaluate mechanisms through which the benefits of practice might be conferred. Primary challenges in this regard include evaluating dose response relationships between practice time and outcomes; clarifying whether physiological and behavioral effects of meditation derive primarily from non-specific aspects of training or result from specific meditation practices; and identifying molecular mechanisms by which meditation might affect physiological responses relevant to stress-related illness. Recent findings from a cross-sectional study by our group indicate that young adults who are randomized to, and practice, compassion meditation demonstrate reduced inflammatory responses, less emotional distress, and reduced autonomic responses to a standardized laboratory psychosocial stressor (Trier Social Stress Test [TSST]) when compared to subjects randomized to an active control condition. However, as a result of the cross-sectional study design and lack of a meditation comparator arm, these results provide only partial insight into key issues outlined above regarding the role played by specific meditation procedures and/or practice time in observed physiological and behavioral outcomes. The primary hypothesis of the proposed work is that practicing a meditation procedure specifically designed to enhance empathic concern for others (i.e. compassion meditation) will optimize autonomic reactivity to psychosocial stress in a manner that results in diminished activation of peripheral inflammatory signaling pathways and reduced behavioral distress.
- Being tested
- Cognitive-Based Compassion Training, Mindful Attention Training, Adult Health Education Curriculum
- Keywords
- inflammation, immune system, cytokines, meditation, compassion, attention
- 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
Mindful Attention TrainingBehavioural
Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.
Adult Health Education CurriculumBehavioural
Eight week training in health and wellness, using a curriculum developed specifically for this study.
| Study group | Role | What they receive |
|---|---|---|
| Compassion Meditation Group | Experimental | Not described Receives: Behavioral: Cognitive-Based Compassion Training |
| Health Education and Wellness Group | Active comparator | Not described Receives: Behavioral: Adult Health Education Curriculum |
| Mindful Attention Training | Experimental | Not described Receives: Behavioral: Mindful Attention Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of compassion meditation on inflammatory and behavioral responses to psychosocial stress using a longitudinal design.
Innate immune cytokine responses will be assessed before and after a psychosocial stressor to evaluate the differential impact of the two interventions and the active control.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startSep 2009
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System ProcessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Sponsor
- Investigators
- Charles Raison, MD, Principal investigator, University of ArizonaLobsang Tenzin Negi, PhD, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251341
- Sponsor's protocol ID
- 5R01AT004698
- Acronym
- CALM
- Status last verified
- Dec 2014
- First submitted
- 30 Nov 2010
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Meditation
- ClinicalTrials.gov ID
- NCT01251341
- Acronym / sponsor ID
- CALM / 5R01AT004698
- Keywords
- inflammation, immune system, cytokines, meditation, compassion, attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- Sep 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The increasingly widespread use of meditation for stress-related emotional and medical conditions highlights the urgent need to rigorously evaluate mechanisms through which the benefits of practice might be conferred. Primary challenges in this regard include evaluating dose response relationships between practice time and outcomes; clarifying whether physiological and behavioral effects of meditation derive primarily from non-specific aspects of training or result from specific meditation practices; and identifying molecular mechanisms by which meditation might affect physiological responses relevant to stress-related illness. Recent findings from a cross-sectional study by our group indicate that young adults who are randomized to, and practice, compassion meditation demonstrate reduced inflammatory responses, less emotional distress, and reduced autonomic responses to a standardized laboratory psychosocial stressor (Trier Social Stress Test [TSST]) when compared to subjects randomized to an active control condition. However, as a result of the cross-sectional study design and lack of a meditation comparator arm, these results provide only partial insight into key issues outlined above regarding the role played by specific meditation procedures and/or practice time in observed physiological and behavioral outcomes. The primary hypothesis of the proposed work is that practicing a meditation procedure specifically designed to enhance empathic concern for others (i.e. compassion meditation) will optimize autonomic reactivity to psychosocial stress in a manner that results in diminished activation of peripheral inflammatory signaling pathways and reduced behavioral distress.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Compassion Meditation Group | Experimental | Behavioral: Cognitive-Based Compassion Training |
| Health Education and Wellness Group | Active comparator | Behavioral: Adult Health Education Curriculum |
| Mindful Attention Training | Experimental | Behavioral: Mindful Attention Training |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Good medical health
Key exclusion criteria (10 listed)
- current major depression
- current substance abuse
- lifetime history of schizophrenia or bipolar disorder type I as assessed by the Structured Diagnostic Interview for DSM-IV (SCID)
- suicidal ideation or suicide attempt within one year of study enrollment
- diagnosis of any serious ongoing medical condition including malignancy, auto-immune disease (i.e. rheumatoid arthritis, multiple sclerosis, Crohn's disease), cardiovascular disease (other than hypertension), seizure disorder, endocrinopathy, chronic infection (i.e. human immunodeficiency virus, hepatitis B or C), renal or hepatic insufficiency, or any other current or past medical or psychiatric condition that might increase the risk of study participation in the opinion of study personnel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Based Compassion TrainingEight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University | Behavioural | Compassion Meditation Group |
| Mindful Attention TrainingEight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D. | Behavioural | Mindful Attention Training |
| Adult Health Education CurriculumEight week training in health and wellness, using a curriculum developed specifically for this study. | Behavioural | Health Education and Wellness Group |
Primary outcome
Effects of compassion meditation on inflammatory and behavioral responses to psychosocial stress using a longitudinal design.
Time frame: Five years
Innate immune cytokine responses will be assessed before and after a psychosocial stressor to evaluate the differential impact of the two interventions and the active control.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Raison, MD principal investigator
University of Arizona
Lobsang Tenzin Negi, PhD study director
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Based Compassion Training, Mindful Attention Training and Adult Health Education Curriculum 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 1 inclusion and 10 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 5 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?
Effects of compassion meditation on inflammatory and behavioral responses to psychosocial stress using a longitudinal design. (time frame: Five years). 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 5 Dec 2014.