A Study of Stress Management Intervention in a Women's Heart Clinic, The Heart SMART Program

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-000081
    NCT ID: NCT02670421
    Sponsor Protocol Number: 16-000081

About this study

The purpose of this study is to see how usefull will the Heart SMART program be in moderate or high stress patients who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Women age 25-75 years
  • Able to speak English and complete questionnaire
  • Self-reported Stress Scale 6 - 10 (visual analog scale of 1 to 10 with 1 being lowest stress and 10 being highest stress)
  • Women in face to face session will have to be able to attend the SMART session
  • Women in the online group will be required to have the ability to use internet to access the online training material

Exclusion Criteria

  • Self-reported Stress Index < 6
  • Pregnant women will be excluded from participation in the study
    • Pregnancy test is not required because the intervention in this study poses no risk
  • Unable to give written consent
  • Inability or refusal to cooperate with study procedures

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Anjali Bhagra, M.D.

Closed for enrollment

Contact information:

Saswati Mahapatra

(507)284-5404

Mahapatra.Saswati@mayo.edu

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CLS-20271282

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