Quantification of Outcome Measures for Mind-body Interventions
2 other identifiers
interventional
455
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedNovember 13, 2015
November 1, 2015
4.5 years
February 24, 2011
November 12, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (3)
Stress Management Group 1
EXPERIMENTALStress Management Group 2
EXPERIMENTALStress Management Group 3
EXPERIMENTALInterventions
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.
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Denninger JW, Joss D, Romero PM, Khalsa SBS, Hoge EA, Bhasin M, Lazar SW, Dusek JA, Macklin E, Libermann T, Fricchione GL, Benson H. Psychological assessments, allostatic load and gene expression analyses in a randomized controlled trial comparing meditation, yoga, and stress education. Front Psychol. 2025 Sep 12;16:1653242. doi: 10.3389/fpsyg.2025.1653242. eCollection 2025.
PMID: 41020112DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John W Denninger, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2011
First Posted
March 4, 2011
Study Start
March 1, 2011
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
November 13, 2015
Record last verified: 2015-11