NCT01308970

Quantification of Outcome Measures for Mind-body Interventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Stress, Psychological
• Stress, Physiological

Interventions

Type	Name	Description
BEHAVIORAL	Stress Management Group 1	Subjects will attend individual stress management sessions once weekly for 8 weeks and will be instructed to listen to a health education CD for 20 minutes every day for the duration of the study.
BEHAVIORAL	Stress Management Group 2	Subjects will attend individual stress management sessions once weekly for 8 weeks and will be instructed to listen to a health education CD for 20 minutes every day for the duration of the study.
BEHAVIORAL	Stress Management Group 3	Subjects will attend individual stress management sessions once weekly for 8 weeks and will be instructed to listen to a health education CD for 20 minutes every day for the duration of the study.

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2011-03-04
• Last updated: 2015-11-13

Locations

1 site across 1 country: United States