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Mindfulness Based Stress Reduction for Metabolic Syndrome (MBSR)

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ClinicalTrials.gov Identifier: NCT03296514
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 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
Intervention
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

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT03296514


Contacts
Contact: kathleen williams, Bsn Mba 475 331-1501 kathleen.williams@yale.edu
Contact: Joan Monin, PhD 412 519-5621

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: kathleen Williams, MBA    475-331-1501    kathleen.williams@yale.edu   
Contact: Joan Monin, PhD    412 519-5621    joan.monin@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
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


Publications:

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

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

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