Mindfulness Based Stress Reduction for Metabolic Syndrome

NCT ID: NCT03296514

Last Updated: 2019-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-10-05

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Wait List Control

Will receive voucher for MBSR after study is concluded

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

These people will receive the MBSR

Group Type OTHER

MBSR

Intervention Type BEHAVIORAL

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

Interventions

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MBSR

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Joan Monin

Associate professor with term

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Monin, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25689576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15256293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18678242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22820409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23009599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19803566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19918956 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2000020175

Identifier Type: -

Identifier Source: org_study_id

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