A Study of Stress Management Intervention in a Women's Heart Clinic, The Heart SMART Program
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Anjali Bhagra, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available