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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670421
Enrollment
50
Registered
2016-02-01
Start date
2016-03-31
Completion date
2017-03-31
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

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.

Interventions

BEHAVIORALFace 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.

BEHAVIORALOn-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.

BEHAVIORALMayo 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Heart SMART Program survey scoreBaseline and 12 weeks

Secondary

MeasureTime frame
Participant's adherence survey score to Heart SMART program16, 20 and 24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026