Back to resultsMindfulness Based Stress Reduction for Metabolic Syndrome (MBSR)
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MBSR
Sponsored by
About this trial
This is an interventional other trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Participant has 3 of the following: a Abdominal Obesity; b. Hypertriglyceridemia; c. Low High Density Lipoproteins (HDL); d. High Blood Pressure; e. High Fasting Blood Sugar (FBS)
- Participant must be married or co- habituating
- Both partners are over sixty
Exclusion Criteria:
- Either partner is non- English speaking
- Either partner practices mind- body therapies more than once a week/
- Either partner taking psychiatric medicine
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Wait List Control
Intervention
Arm Description
Will receive voucher for MBSR after study is concluded
These people will receive the MBSR
Outcomes
Primary Outcome Measures
Self- reported physical health status
SF 12
Perceived stress
Perceived stress scale,
Mindfulness Skills
Kentucky Inventory of Mindfulness Skills
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03296514
Brief Title
Mindfulness Based Stress Reduction for Metabolic Syndrome
Acronym
MBSR
Official Title
Mindfulness-Based Stress Reduction Study for Couples
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mindfulness based stress reduction offered to couples where one has metabolic syndrome to see if their stress is reduced as measured by bio markers and surveys
Detailed Description
This is a pilot study being designed to pilot a MBSR program for the purposes of future research.The investigators will be using two cohorts. One who will get the intervention and the other who will be wait listed and receive the intervention at a later date. Eight week mindfulness class offered to couples, who also attend an orientation session and a half day retreat with other couples to learn how to control stress through mindfulness meditation practices. Participants will come for lab work before intervention, eight weeks after initial class and at the end of entire program. Bio- markers to be measured are waist circumference, FBS and cholesterol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Will receive voucher for MBSR after study is concluded
Arm Title
Intervention
Arm Type
Other
Arm Description
These people will receive the MBSR
Intervention Type
Behavioral
Intervention Name(s)
MBSR
Intervention Description
Eight week class on MBSR in addition to an orientation class and a half day retreat
Primary Outcome Measure Information:
Title
Self- reported physical health status
Description
SF 12
Time Frame
Up to three weeks after intervention ends
Title
Perceived stress
Description
Perceived stress scale,
Time Frame
Up to three weeks after intervention ends
Title
Mindfulness Skills
Description
Kentucky Inventory of Mindfulness Skills
Time Frame
Up to three weeks after intervention ends
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant has 3 of the following: a Abdominal Obesity; b. Hypertriglyceridemia; c. Low High Density Lipoproteins (HDL); d. High Blood Pressure; e. High Fasting Blood Sugar (FBS)
Participant must be married or co- habituating
Both partners are over sixty
Exclusion Criteria:
Either partner is non- English speaking
Either partner practices mind- body therapies more than once a week/
Either partner taking psychiatric medicine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Monin, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25689576
Citation
Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015 Apr;37:1-12. doi: 10.1016/j.cpr.2015.01.006. Epub 2015 Jan 31. Erratum In: Clin Psychol Rev. 2016 Nov;49:119.
Results Reference
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PubMed Identifier
15256293
Citation
Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.
Results Reference
background
PubMed Identifier
18678242
Citation
Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.
Results Reference
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PubMed Identifier
22820409
Citation
Creswell JD, Irwin MR, Burklund LJ, Lieberman MD, Arevalo JM, Ma J, Breen EC, Cole SW. Mindfulness-Based Stress Reduction training reduces loneliness and pro-inflammatory gene expression in older adults: a small randomized controlled trial. Brain Behav Immun. 2012 Oct;26(7):1095-101. doi: 10.1016/j.bbi.2012.07.006. Epub 2012 Jul 20.
Results Reference
background
PubMed Identifier
23009599
Citation
Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25;12:162. doi: 10.1186/1472-6882-12-162.
Results Reference
background
PubMed Identifier
19803566
Citation
Biegel GM, Brown KW, Shapiro SL, Schubert CM. Mindfulness-based stress reduction for the treatment of adolescent psychiatric outpatients: A randomized clinical trial. J Consult Clin Psychol. 2009 Oct;77(5):855-66. doi: 10.1037/a0016241.
Results Reference
background
PubMed Identifier
19918956
Citation
Birnie K, Garland SN, Carlson LE. Psychological benefits for cancer patients and their partners participating in mindfulness-based stress reduction (MBSR). Psychooncology. 2010 Sep;19(9):1004-9. doi: 10.1002/pon.1651.
Results Reference
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Learn more about this trial
Mindfulness Based Stress Reduction for Metabolic Syndrome
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