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Quantification of Outcome Measures for Mind-body Interventions

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ClinicalTrials.gov Identifier: NCT01308970
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : November 13, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Stress, Psychological Stress, Physiological 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 455 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Quantification of Outcome Measures for Mind-body Interventions
Study Start Date : March 2011
Primary Completion Date : September 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
    Perceived Stress Scale (PSS-10)

  2. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308970


Locations
United States, Massachusetts
Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: John W Denninger, MD, PhD Massachusetts General Hospital
More Information

Responsible Party: John W. Denninger, MD, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01308970     History of Changes
Other Study ID Numbers: 2010P002785
R01AT006464 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms