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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT006464 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stress Management Group 1 | Experimental |
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| Stress Management Group 2 | Experimental |
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| Stress Management Group 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Management Group 1 | 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. |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Denninger, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41020112 | Derived | 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. |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Stress Management Group 2 | 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. |
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| Stress Management Group 3 | 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. |
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