Quantification of Outcome Measures for Mind-body Interventions

Stress, Psychological Clinical Trial

Official title:

Quantification of Outcome Measures for Mind-body Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308970
• Other study ID #: 2010P002785
• Secondary ID: R01AT006464
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: November 12, 2015
• Start date: March 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Benson-Henry Institute for Mind Body Medicine; Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Change in Genomic Expression Profile Post-intervention and at 6-month Follow-up		Baseline (Week 1), Endpoint (Week 9), Follow-Up (Week 26)	No