NCT03296514

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

September 20, 2017

Last Update Submit

January 8, 2019

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (3)

  • Self- reported physical health status

    SF 12

    Up to three weeks after intervention ends

  • Perceived stress

    Perceived stress scale,

    Up to three weeks after intervention ends

  • Mindfulness Skills

    Kentucky Inventory of Mindfulness Skills

    Up to three weeks after intervention ends

Study Arms (2)

Wait List Control

NO INTERVENTION

Will receive voucher for MBSR after study is concluded

Intervention

OTHER

These people will receive the MBSR

Behavioral: MBSR

Interventions

MBSRBEHAVIORAL

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

Intervention

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (7)

  • 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.

    PMID: 25689576BACKGROUND

  • 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.

    PMID: 15256293BACKGROUND

  • 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.

    PMID: 18678242BACKGROUND

  • 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.

    PMID: 22820409BACKGROUND

  • 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.

    PMID: 23009599BACKGROUND

  • 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.

    PMID: 19803566BACKGROUND

  • 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.

    PMID: 19918956BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Joan Monin, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor with term

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 28, 2017

Study Start

July 1, 2017

Primary Completion

October 5, 2018

Study Completion

October 5, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)