Quantification of Outcome Measures for Mind-body Interventions

Completed · Not applicable

Conditions studied: Stress, Psychological, Stress, Physiological

In brief

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).

Key facts

Study ID

NCT01308970

Run by

Massachusetts General Hospital

People needed

455

Starts

2011-03-01

Expected to finish

2015-10-01

Last updated by the study team

2015-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.