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OpenTrials
Completed

NCT Number: NCT02670421

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

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?

Completed

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Key information

Conditions

Stress

Age range

25 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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

Treatment and study plan

Face to Face Heart SMART Program

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in Heart SMART Program survey score

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Participant's adherence survey score to Heart SMART program

    Time frame: 16, 20 and 24 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2016
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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