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Mindfulness Based Stress Reduction for Metabolic Syndrome (MBSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03296514
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Joan Monin, Yale University

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: MBSR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mindfulness-Based Stress Reduction Study for Couples
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Wait List Control
Will receive voucher for MBSR after study is concluded
These people will receive the MBSR
Behavioral: MBSR
Eight week class on MBSR in addition to an orientation class and a half day retreat

Primary Outcome Measures :
  1. Self- reported physical health status [ Time Frame: Up to three weeks after intervention ends ]
    SF 12

  2. Perceived stress [ Time Frame: Up to three weeks after intervention ends ]
    Perceived stress scale,

  3. Mindfulness Skills [ Time Frame: Up to three weeks after intervention ends ]
    Kentucky Inventory of Mindfulness Skills

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03296514

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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
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Principal Investigator: Joan Monin, PhD Professor
  Study Documents (Full-Text)

Documents provided by Joan Monin, Yale University:
Study Protocol  [PDF] July 19, 2017
Informed Consent Form  [PDF] July 19, 2017


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Responsible Party: Joan Monin, Associate professor with term, Yale University Identifier: NCT03296514     History of Changes
Other Study ID Numbers: 2000020175
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases