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

Mayo Clinic

Status: Completed

Conditions: Stress

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02670421

16-000081

Details and patient eligibility

About

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?

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Face to face Heart SMART program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Face to Face Heart SMART Program

Behavioral: Mayo Clinic Guide to Stress Free Living

Online Heart SMART program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Mayo Clinic Guide to Stress Free Living

Behavioral: On-line Heart SMART Program