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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670421
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Anjali Bhagra, 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?

Condition or disease Intervention/treatment Phase
Stress Behavioral: Face to Face Heart SMART Program Behavioral: On-line Heart SMART Program Behavioral: Mayo Clinic Guide to Stress Free Living Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Stress Management Intervention in Women's Heart Clinic, Heart SMART Program
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Active Comparator: 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.
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.

Behavioral: 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.

Active Comparator: Online 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.
Behavioral: 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.

Behavioral: 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.




Primary Outcome Measures :
  1. Change in Heart SMART Program survey score [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Participant's adherence survey score to Heart SMART program [ Time Frame: 16, 20 and 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670421


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Anjali Bhagra, MBBS Mayo Clinic
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Responsible Party: Anjali Bhagra, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02670421    
Other Study ID Numbers: 16-000081
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No