A Mixed Methods Evaluation of HPI Resilience Intervention Study
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|ClinicalTrials.gov Identifier: NCT03451240|
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress||Behavioral: Corporate Athlete® Resilience||Not Applicable|
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").
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||To determine the impact of the Corporate Athlete® Resilience product through recalibrating mindset and changing resilience supportive behavior.|
|Masking:||None (Open Label)|
|Official Title:||A Mixed Methods Evaluation of HPI Resilience Intervention Study|
|Actual Study Start Date :||September 16, 2017|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Behavioral: Corporate Athlete® Resilience
The product Corporate Athlete® Resilience Training Program ("CAR Training"), is a one day training program aimed to educate participants about stress management and stress recovery techniques.
The content of the training program is divided into two parts:
- Stress Mindset Measure-General (SMM-G) [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention (assessing for a change) ]The Stress Mindset Measure-General (SMM-G) is an 8-item measure developed to address the extent to which an individual adopts a mindset that the effects of stress are enhancing or debilitating.
- Energy Management Behaviors [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention (assessing for a change) ]The Energy Management Behaviors (EMB) assessment tool consists of 40 items measuring the impact of an individual's behavior, their desired life changes as well as their stress, recovery and energy.
- Qualitative Interviews [ Time Frame: 3-60 days post intervention ]A qualitative telephone or video interview where the grounded theory research method will be used to understand 'the phenomena that occur across participants'. The purpose is to understand how participants recalibrate their mindsets and the impact of recalibration on their resilience behaviours following attendance at a one day training event.
- Brief Resilience Scale (BRS) [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention ]The Brief Resilience Scale (BRS) is a 6-item measure created to assess the ability to bounce back or recover from stress. It is scored by reverse coding items 2, 4, and 6 and finding the mean of the six items. A higher score equals higher resilience.
- Public Health Surveillance Wellbeing (PHS-WB) [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention ]The Public Health Surveillance Well-Being Scale (PHS-WB) comprises 10-items guaging self-reported mental, physical, and social components of well-being. Response options for 6 of the items are on a 5-point Likert-type scale. The responses options range from "strongly disagree" to "strongly agree," "none of the time" to "all of the time," and "poor" to "excellent." Three of the items are based on a 10-point Likert-type scale. Response options for the 10-point items range from "very dissatisfied" to "very satisfied." One item assesses energy/vitality over the past 30 day. The responses for that item ranged from 0 to 30. A score for the PHS-WB scale was created by summing the 10 items for each respondent.
- Sleep Habits (Rand MOS) [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention ]The MOS Sleep Scale is a 12-item instrument, which measures multiple facets of sleep. The MOS Sleep Scale yields a sleep problems index and six scale scores: sleep disturbance (have trouble falling asleep, how long to fall asleep, sleep was not quiet, awaken during your sleep time, and have trouble falling asleep again), sleep adequacy (get enough sleep to feel rested upon waking in the morning and get amount of sleep needed), daytime somnolence (drowsy during day, have trouble staying awake during the day, and take naps), snoring, awaken short of breath or with headache, and quantity of sleep. Quantity of sleep is scored as the average hours slept per night. The other scales and problems index are scored on a range from 0 to 100 with higher scores indicating more of the concept being measured.
- Health, Wellbeing and Productivity (SF36, HPQ) [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention ]The SF-36 is a 36-item questionnaire which measures QoL across eight domains, which are both physically- and emotionally-based. The eight domains that the SF-36 measures are as follows: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health.
- Work Productivity and Activity Impairment (WPAI) [ Time Frame: between 3-weeks to the day of intervention for baseline, 1-month post intervention ]The WPAI:GH is a six-item questionnaire, measuring the effect of one's health problems on their ability to work and perform regular activities. The questions have four scores: (1) percentage work time missed due to health (absenteeism); (2) percentage impairment at work due to health (presenteeism); (3) percentage overall work productivity loss due to health (absenteeism and presenteeism); and (4) percentage daily activity impairment outside of work due to health. Higher scores indicate prolonged sick leave or impairment and decreased productivity.
- Brief Cope [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention ]The Brief COPE inventory is a 28-item measure used to assess ways that an individual copes with stress in their life, in particular around the time a stressful event has occurred.
- Perceived Stress (PSS) [ Time Frame: 3-weeks to the day of intervention for baseline, 1-month post intervention ]The Perceived Stress Scale (PSS) is a 10-item scale used to measure the perception of stress, specifically, the degree which situations in one's life are appraised as stressful.The total score is calculated by finding the sum of 10 items, reverse coding questions 4, 5, 7, & 8. The PSS has a range of scores between 0 (no stress) and 40 (high stress). A higher score indicates more stress.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451240
|United States, Florida|
|The Human Performance Institute|
|Orlando, Florida, United States, 32827|
|Principal Investigator:||Shawn Mason, PhD||Johnson & Johnson Health and Wellness Solutions|