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

• ClinicalTrials.gov Identifier: NCT02670421
• Recruitment Status: Completed
• First Posted: February 1, 2016
• Last Update Posted: March 24, 2017
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Anjali Bhagra, Mayo Clinic

Tracking Information

• First Submitted Date: January 28, 2016
• First Posted Date: February 1, 2016
• Last Update Posted Date: March 24, 2017
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 29, 2016): Change in Heart SMART Program survey score [ Time Frame: Baseline and 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 29, 2016): Participant's adherence survey score to Heart SMART program [ Time Frame: 16, 20 and 24 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Stress Management Intervention in Women's Heart Clinic, Heart SMART Program
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Stress

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 22, 2017): 50
• Original Estimated Enrollment (submitted: January 29, 2016): 40
• Actual Study Completion Date: March 2017
• Actual Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 25 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02670421
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Anjali Bhagra, Mayo Clinic
• Study Sponsor: Mayo Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anjali Bhagra, MBBS; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: March 2017