Trial record 8 of 1493 for:    "Mayo Clinic" [Exact]

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Anjali Bhagra, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02670421
First received: January 28, 2016
Last updated: January 29, 2016
Last verified: January 2016
  Purpose
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 Intervention
Stress
Behavioral: Face to Face Heart SMART Program
Behavioral: On-line Heart SMART Program
Behavioral: Mayo Clinic Guide to Stress Free Living

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Stress Management Intervention in Women's Heart Clinic, Heart SMART Program

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Heart SMART Program survey score [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participant's adherence survey score to Heart SMART program [ Time Frame: 16, 20 and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 PSS (Perceived Stress Scale), BRS (Brief Resilience Scale), PHQ-9 (Patient Health Questionnaire) and GAD-7 (Generalized Anxiety Disorder), 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.

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.
  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02670421

Contacts
Contact: Saswati Mahapatra, MS 507-284-4504 Mahapatra.Sawarti@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Anjali Bhagra, MBBS Mayo Clinic
  More Information

No publications provided

Responsible Party: Anjali Bhagra, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02670421     History of Changes
Other Study ID Numbers: 16-000081 
Study First Received: January 28, 2016
Last Updated: January 29, 2016
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 11, 2016