Stress Clinical Trial
Official title:
A Mixed Methods Evaluation of HPI Resilience Intervention Study
The primary objective of the Resilience Study is to determine the impact of the Corporate
Athlete® Resilience product through recalibrating mindset and changing resilience supportive
behavior.
Analysis will be performed via Survey and Study Interviews (two methods) to determine how the
CAR Training recalibrated and impacted the Research Participants mindset and resilience
state.
1. Tool: Stress Mindset Measure-General (SMM-G)
Additional analysis will evaluate participants' engagement in behavior changes in the first
30 days.
2. Tool: Energy Management Behaviors.
Secondary objectives include further analysis to determine if the intervention group
demonstrated significant improvements in the following measures:
1. Brief Resilience Scale (BRS)
2. Public Health Surveillance Wellbeing (PHS-WB)
3. Sleep Habits (Rand MOS)
4. Health, Wellbeing and Productivity (SF36, HPQ)
5. Work Productivity and Activity Impairment (WPAI)
6. Brief Cope
7. Perceived Stress (PSS)
In addition, demographic assessments will be collected.
Methodology: This is an interventional mixed methods (qualitative & quantitative) study,
with pre-post design for research participants in one session. All participants will be
measured at two time points: surveys will be collected between 3-weeks to the day of
intervention for baseline, 1-month post intervention.
In addition, Qualitative interviews will be conducted on a rolling basis between 3-60 days
post intervention. The qualitative portion is a semi-structured interview will be conducted
with the purpose of understanding how participants recalibrated their mindset and impacting
their resilience behaviors.
Study Advertisement combined with the Resilience Program Advertisement will be posted by the
Lake Nona Institute. Potential Research Participants will be self-selected, and will contact
the Lake Nona Study Coordinator for additional information. The self-selected individuals
will receive HPI materials via mail, in addition to Study and Resilience Program eligibility
information.
Potential Research Participants will undergo Screening and Consenting procedures at the Lake
Nona Institute. The Research Participant will be required to sign and date a paper based
Informed Consent Document, and provide additional contact information, such as individual
email address, phone number etc.
Enrolled Research Participants will be scheduled to attend the CAR Training Session.
On the day of the CAR Training, the Research Participants will receive a set of
questionnaires as part of the Corporate Athlete® Resilience Program ("HPI Questionnaire"), in
addition to a set of Study Specific Questionnaires ("Study Questionnaire"). A description
study activities ("Study Guide") and a description of session activities ("Agenda") consists
of the introduction to stress and resilience session, will be distributed to all Research
Participants.
30 days following the CAR Training, the Research Participants will receive a follow-up HPI
questionnaires and a Study questionnaires which will be utilized in the Resilience Research
Study Analysis.
3-60 days upon completion of the CAR Training, the Research Participants will be asked to
complete a Research Study Qualitative Telephone, Video or Face-to-Face Interview ("Study
Interview").
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