Quantification of Outcome Measures for Mind-body Interventions

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).

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Stress, Physiological
• Intervention / Treatment: Behavioral: Stress Management Group 1; Behavioral: Stress Management Group 2; Behavioral: Stress Management Group 3

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.

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stress Management Group 1	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.
EXPERIMENTAL: Stress Management Group 2	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.
EXPERIMENTAL: Stress Management Group 3	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress Levels Post-intervention and at 6-month Follow-up	Perceived Stress Scale (PSS-10)	Baseline (Week 1), Endpoint (Week 9), Follow-Up (Week 26)
Change in Genomic Expression Profile Post-intervention and at 6-month Follow-up		Baseline (Week 1), Endpoint (Week 9), Follow-Up (Week 26)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (ESTIMATE): March 4, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 12, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 2010P002785; R01AT006464 (NIH)