Quantification of Outcome Measures for Mind-body Interventions
This study is currently recruiting participants.
Verified January 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Herbert Benson, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01308970
First received: February 24, 2011
Last updated: January 4, 2012
Last verified: January 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Stress, Psychological Stress, Physiological |
Behavioral: Stress Management Group 1 Behavioral: Stress Management Group 2 Behavioral: Health Education Group 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Change in Perceived Stress Levels Post-intervention and at 6-month Follow-up [ Time Frame: Baseline (Week 1), Endpoint (Week 9), Follow-Up (Week 26) ] [ Designated as safety issue: No ]Perceived Stress Scale (PSS-10)
- Change in Genomic Expression Profile Post-intervention and at 6-month Follow-up [ Time Frame: Baseline (Week 1), Endpoint (Week 9), Follow-Up (Week 26) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 275 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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: Health Education 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308970
Contacts
| Contact: Lauren E Slipp, BS | 617-643-6047 | bhiresearchstudies@partners.org |
Locations
| United States, Massachusetts | |
| Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Herbert Benson, MD | |
| Sub-Investigator: John Denninger, MD, PhD | |
Sponsors and Collaborators
Massachusetts General Hospital
More Information
No publications provided
| Responsible Party: | Herbert Benson, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01308970 History of Changes |
| Other Study ID Numbers: | 2010P002785, R01AT006464 |
| Study First Received: | February 24, 2011 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Stress, Psychological Behavioral Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013