Stress Management Intervention in Women's Heart Clinic, Heart SMART Program

Not Applicable

Completed

• Conditions: Stress
• Interventions: Behavioral: Face to Face Heart SMART Program; Behavioral: On-line Heart SMART Program; Behavioral: Mayo Clinic Guide to Stress Free Living

• Registration Number: NCT02670421
• Lead Sponsor: Mayo Clinic

Brief Summary

Will the intervention (Heart SMART program) be feasible in moderate or high stress patients, who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic?

Detailed Description

The Heart SMART Program is designed to offer a practical and efficacious stress management and resiliency intervention. It involves making participants aware of practices to enhance present moment awareness and engagement. It teaches learners to train their attention, and refine interpretation; utilizing principles of gratitude, compassion, acceptance, higher meaning and forgiveness. Participants will choose to use one of two delivery methods (either the face to face method or the on-line method) of the Heart SMART program.

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-01
• Study Start: 2016-03
• Primary Completion: 2017-02
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face to face Heart SMART program	Mayo Clinic Guide to Stress Free Living	Stress management program presented in a face to face meeting of 90-100 minutes with daily printed program instructions to follow over the next 12 weeks, accompanied by reading from a book entitled The Mayo Clinic Guide to Stress Free Living.
Online Heart SMART program	Mayo Clinic Guide to Stress Free Living	Stress management program in the form of 10- minute videos completed weekly by participant on-line for 12 weeks, accompanied by reading from a book entitled The Mayo Clinic Guide to Stress Free Living.
Face to face Heart SMART program	Face to Face Heart SMART Program	Stress management program presented in a face to face meeting of 90-100 minutes with daily printed program instructions to follow over the next 12 weeks, accompanied by reading from a book entitled The Mayo Clinic Guide to Stress Free Living.
Online Heart SMART program	On-line Heart SMART Program	Stress management program in the form of 10- minute videos completed weekly by participant on-line for 12 weeks, accompanied by reading from a book entitled The Mayo Clinic Guide to Stress Free Living.

Primary Outcome Measures

Name	Time	Method
Change in Heart SMART Program survey score	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Participant's adherence survey score to Heart SMART program	16, 20 and 24 weeks

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States