Quantification of Outcome Measures for Mind-body Interventions

NCT ID: NCT01308970

Last Updated: 2015-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 455 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2015-10-31

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).

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.

Conditions

Stress, Psychological; Stress, Physiological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Stress Management Group 1

Group Type: EXPERIMENTAL

Stress Management Group 1

Intervention Type: BEHAVIORAL

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.

Stress Management Group 2

Group Type: EXPERIMENTAL

Stress Management Group 2

Intervention Type: BEHAVIORAL

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.

Stress Management Group 3

Group Type: EXPERIMENTAL

Stress Management Group 3

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

John W. Denninger, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John W Denninger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 41020112 (View on PubMed)

Other Identifiers

R01AT006464

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010P002785

Identifier Type: -

Identifier Source: org_study_id