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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670421
• Other study ID #: 16-000081
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: March 22, 2017
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Face to Face Heart SMART Program
The Heart SMART stress management program survey consists of Perceived Stress Scale (PSS), Brief Resilience Scale (BRS), Patient Health Questionnaire (PHQ - 9) and Generalized Anxiety Disorder (GAD - 7), followed by email communication every three weeks.
• On-line Heart SMART Program
The Heart SMART stress management program survey consists of PSS (Perceived Stress Scale), BRS (Brief Resilience Scale), PHQ-9 (Patient Health Questionnaire) and GAD-7 (Generalized Anxiety Disorder) taken on-line in twelve, 10 minutes sessions.
• Mayo Clinic Guide to Stress Free Living
All subjects will be provided with a copy of the book entitled Mayo Clinic Guide to Stress Free Living and encouraged to read it over the twelve week study period.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart SMART Program survey score		Baseline and 12 weeks
Secondary	Participant's adherence survey score to Heart SMART program		16, 20 and 24 weeks