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CompletedNCT03296514MBSRUpdated Jan 9, 2019

Mindfulness Based Stress Reduction for Metabolic Syndrome

An interventional study of MBSR in Metabolic Syndrome, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by Yale University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Metabolic Syndrome
03

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Either partner is non- English speaking
  • Either partner practices mind- body therapies more than once a week/
  • Either partner taking psychiatric medicine
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • No intervention
    Wait List Control

    Will receive voucher for MBSR after study is concluded

  • Other
    Intervention

    These people will receive the MBSR

    Behavioral: MBSR

Interventions

  • BehavioralMBSR

    Eight week class on MBSR in addition to an orientation class and a half day retreat

05

What researchers measure

Primary outcomes

  1. Self- reported physical health status

    SF 12

    Time frame: Up to three weeks after intervention ends

  2. Perceived stress

    Perceived stress scale,

    Time frame: Up to three weeks after intervention ends

  3. Mindfulness Skills

    Kentucky Inventory of Mindfulness Skills

    Time frame: Up to three weeks after intervention ends

06

Study locations

1 site
  • Yale University
    New Haven, Connecticut 06511, United States
07

References and documents

Publications

  • 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. doi: 10.1016/j.cpr.2016.09.011. PubMed 25689576 ↗
  • 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. PubMed 15256293 ↗
  • 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. PubMed 18678242 ↗
  • 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. PubMed 22820409 ↗
  • 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. PubMed 23009599 ↗
  • 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. PubMed 19803566 ↗
  • 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. PubMed 19918956 ↗

Study documents

  • Study protocol · Jul 19, 2017
  • Informed consent form · Jul 19, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03296514
Lead sponsor
Yale University
Responsible party
Joan Monin (Associate professor with term, Yale University) — Principal investigator
First posted
Sep 28, 2017
Start date
Jul 1, 2017
Primary completion
Oct 5, 2018
Completion
Oct 5, 2018
Last update
Jan 9, 2019

Study contacts

Joan Monin, PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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