Quantification of Outcome Measures for Mind-body Interventions

Stress, Psychological Clinical Trial

Official title: Quantification of Outcome Measures for Mind-body Interventions

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological

• NCT number: NCT01308970
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Completion date: October 2015