Stress, PsychologicalNCT01308970
Quantification of Outcome Measures for Mind-body Interventions
A study testing Stress Management Group 1, Stress Management Group 2 and Stress Management Group 3 in people with Stress, Psychological and Stress, Physiological, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress, Physiological
- What is being tested?
- Stress Management Group 1, Stress Management Group 2 and Stress Management Group 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the 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
- Being tested
- Stress Management Group 1, Stress Management Group 2, Stress Management Group 3
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management Group 1Behavioural
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 2Behavioural
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 3Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Management Group 1 | Experimental | Not described Receives: Behavioral: Stress Management Group 1 |
| Stress Management Group 2 | Experimental | Not described Receives: Behavioral: Stress Management Group 2 |
| Stress Management Group 3 | Experimental | Not described Receives: Behavioral: Stress Management Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Levels Post-intervention and at 6-month Follow-up
Perceived Stress Scale (PSS-10)
Measured: Baseline (Week 1), Endpoint (Week 9), Follow-Up (Week 26)
Change in Genomic Expression Profile Post-intervention and at 6-month Follow-up
Measured: Baseline (Week 1), Endpoint (Week 9), Follow-Up (Week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, John W. Denninger, MD, PhD, Massachusetts General Hospital
- Investigators
- John W Denninger, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308970
- Sponsor's protocol ID
- 2010P002785
- Other IDs
- R01AT006464
- Status last verified
- Nov 2015
- First submitted
- 24 Feb 2011
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 41020112
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Outcome Measures for Mind-body Interventions
- ClinicalTrials.gov ID
- NCT01308970
- Acronym / sponsor ID
- 2010P002785
- Conditions
- Stress, Psychological, Stress, Physiological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Mar 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stress Management Group 1 | Experimental | Behavioral: Stress Management Group 1 |
| Stress Management Group 2 | Experimental | Behavioral: Stress Management Group 2 |
| Stress Management Group 3 | Experimental | Behavioral: Stress Management Group 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Management Group 1Subjects 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. | Behavioural | Stress Management Group 1 |
| Stress Management Group 2Subjects 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. | Behavioural | Stress Management Group 2 |
| Stress Management Group 3Subjects 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. | Behavioural | Stress Management Group 3 |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Derived from this study: PubMed 41020112Denninger 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Denninger, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Management Group 1, Stress Management Group 2 and Stress Management Group 3 in people with Stress, Psychological and Stress, Physiological, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01308970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015; AzTrials last refreshed its copy on 1 Nov 2026.