CClinicalTrials.gg
CompletedNCT02670421Updated Mar 24, 2017

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

An interventional study of Face to Face Heart SMART Program and On-line Heart SMART Program in Stress, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
25 Years to 75 Years
Sex
Female
01

Study 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?

Read the 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.

02

Conditions studied

  • Stress
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

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.

    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.

    Behavioral: On-line Heart SMART Program · Behavioral: Mayo Clinic Guide to Stress Free Living

Interventions

  • BehavioralFace 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.

  • BehavioralOn-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.

  • BehavioralMayo 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.

06

What researchers measure

Primary outcomes

  1. Change in Heart SMART Program survey score

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Participant's adherence survey score to Heart SMART program

    Time frame: 16, 20 and 24 weeks

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02670421
Lead sponsor
Mayo Clinic
Responsible party
Anjali Bhagra (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Feb 1, 2016
Start date
Mar 2016
Primary completion
Feb 2017
Completion
Mar 2017
Last update
Mar 24, 2017

Study contacts

Anjali Bhagra, MBBS
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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