View Clinical Trial (Medical Research Study)
Quantification of Outcome Measures for Mind-body Interventions
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02114 |
| Conditions: |
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Stress, Psychological - Stress, Physiological |
| Purpose: |
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The purpose of this study is to determine if participation in one of three different health
management groups will elicit genomic and biochemical changes and decrease perceived stress
levels and symptoms in healthy, stressed adults. The investigators expect that changes in
self-reported psychological stress and symptoms will be directly linked to changes in
biological indicators (genomic expression profiles and neuroendocrine and pro-inflammatory
biomarkers).
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| Study Summary: |
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This randomized, controlled trial will determine the relative strength of correlation
between changes in stress outcome measures (self-report questionnaire, genomic expression,
biochemical assay) in moderately to severely stressed healthy subjects randomized to one of
three health education interventions at both end-intervention and at a 6-month long-term
follow-up. This study will also determine which of the different outcome measures exhibit
the greatest degree of sensitivity, reliability and consistency at both end-intervention and
long-term follow-up.
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| Criteria: |
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Inclusion Criteria:
- Age 18 or older
- Stress is chronic and ongoing with no resolution of the stressors within the
timeframe of the study, with a minimum prior duration of 6 months.
- Able to provide informed consent and to understand written and spoken English.
Exclusion Criteria:
- Practice of yoga, meditation, guided imagery or other mind body techniques that
elicit the RR, once per week for 45 min total or more within the last three months or
less.
- Any current medical condition that would preclude their safe and effective practice
of the yoga or meditation interventions.
- The presence of bipolar or psychotic disorders, or history of any other DSMIV Axis I
disorder with active symptoms or treatment within the last 5 years, as determined by
a structured clinical interview.
- Initiation of psychotherapy within 6 months of entering the study.
- Serious or unstable medical illness, including serious or unstable cardiovascular,
hepatic, renal, respiratory, endocrine, neurologic or hematologic disease.
- Patient deemed unable to complete protocol due to cognitive, psychiatric or other
reasons.
- Pregnancy or planned conception over the course of the study (could confound
biomarker values).
- Current use of the following medications: systemic corticosteroids, chronic (i.e.,
more than 3 days per week) use of anti-inflammatories (e.g., ibuprofen; currently or
within the last 3 months), immunosuppressive or cytotoxic therapies (currently or
within the last 12 months), and anabolic steroids.
- Current (within the last 6 months) psychoactive medications (e.g. antidepressants,
mood stabilizers, antipsychotics, anxiolytics), with the exception of hypnotics,
which will be permitted.
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| NCT ID: |
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NCT01308970 |
| Primary Contact: |
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Lauren E Slipp, BS
Phone: 617-643-6047
Email: bhiresearchstudies@partners.org
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| Backup Contact: |
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N/A |
| Location Contact: |
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Boston, Massachusetts 02114
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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