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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

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 1, 2016
Last Update Posted Date March 24, 2017
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Change in Heart SMART Program survey score [ Time Frame: Baseline and 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Participant's adherence survey score to Heart SMART program [ Time Frame: 16, 20 and 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stress Management Intervention in Women's Heart Clinic, Heart SMART Program
Official Title  ICMJE Stress Management Intervention in Women's Heart Clinic, Heart SMART Program
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Stress
Intervention  ICMJE
  • 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: 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Face to Face Heart SMART Program
    • Behavioral: Mayo Clinic Guide to Stress Free Living
  • 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.
    Interventions:
    • Behavioral: On-line Heart SMART Program
    • Behavioral: Mayo Clinic Guide to Stress Free Living
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
40
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670421
Other Study ID Numbers  ICMJE 16-000081
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anjali Bhagra, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anjali Bhagra, MBBS Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP