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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02670421
Collaborator
(none)
50
1
2
12
4.2

Study Details

Study Description

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
  • Behavioral: Face to Face Heart SMART Program
  • Behavioral: On-line Heart SMART Program
  • Behavioral: Mayo Clinic Guide to Stress Free Living
N/A

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 Design

Study Type:
Interventional
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 :
Mar 1, 2016
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Heart SMART Program survey score [Baseline and 12 weeks]

Secondary Outcome Measures

  1. Participant's adherence survey score to Heart SMART program [16, 20 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Anjali Bhagra, MBBS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anjali Bhagra, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02670421
Other Study ID Numbers:
  • 16-000081
First Posted:
Feb 1, 2016
Last Update Posted:
Mar 24, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 24, 2017