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MBSR: Mindfulness Based Stress Reduction for Metabolic Syndrome

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT03296514
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
15.1
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MBSR
 N/A

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 Design

Study Type:
Interventional
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 :
Jul 1, 2017
Actual Primary Completion Date :
Oct 5, 2018
Actual Study Completion Date :
Oct 5, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Wait List Control

Will receive voucher for MBSR after study is concluded
Other: 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

Outcome Measures

Primary Outcome Measures

  1. Self- reported physical health status [Up to three weeks after intervention ends]

    SF 12

  2. Perceived stress [Up to three weeks after intervention ends]

    Perceived stress scale,

  3. Mindfulness Skills [Up to three weeks after intervention ends]

    Kentucky Inventory of Mindfulness Skills

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 90 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University New Haven Connecticut United States 06511

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Joan Monin, PhD, Professor

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Joan Monin, Associate professor with term, Yale University
ClinicalTrials.gov Identifier:
NCT03296514
Other Study ID Numbers:
  • 2000020175
First Posted:
Sep 28, 2017
Last Update Posted:
Jan 9, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
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:
Metabolic Syndrome
Syndrome

Study Results

No Results Posted as of Jan 9, 2019