StressNCT03451240
A Mixed Methods Evaluation of HPI Resilience Intervention Study
A study testing Corporate Athlete® Resilience in people with Stress, run by Johnson & Johnson Health and Wellness Solutions, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Corporate Athlete® Resilience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be an adult (18 years or older);
- Be a participant in the LNLP (i.e., provided consent for the project);
- Meet =>2 stress experience level parameters on Stress Mindset Measure-General (SMM-G);
- Meet =< 4.3 on the Brief Resilience Scale (BRS);
- Be willing to attend a full day training program at the Lake Nona Institute during the designated training date;
- Be willing to provide email and phone number as a contact method;
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- Must speak, read, and understand English fluently;
- Be able to comprehend and follow the requirements of the study;
- Research Participant must have a valid e-mail address;
- Be able to provide Informed Consent;
- Be willing and able to comply with all study procedures for the duration of the study.
Who cannot join
- Is not an adult (18 years or older);
- Has not consented to participate in the LNLP;
- Does not meet the stress or resilience parameters (as defined above);
- Unwilling or unable to provide consent and sign the ICF;
- Unwilling or unable to complete study related questionnaires;
- Have a physical or cognitive impairment that would interfere with their ability to provide accurate information;
- Not able to speak, read, or understand English fluently.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Human Performance Institute
Orlando, Florida, 32827
About this 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.
Read more
- Tool: Stress Mindset Measure-General (SMM-G)
Additional analysis will evaluate participants' engagement in behavior changes in the first 30 days.
- Tool: Energy Management Behaviors.
Secondary objectives include further analysis to determine if the intervention group demonstrated significant improvements in the following measures:
- Brief Resilience Scale (BRS)
- Public Health Surveillance Wellbeing (PHS-WB)
- Sleep Habits (Rand MOS)
- Health, Wellbeing and Productivity (SF36, HPQ)
- Work Productivity and Activity Impairment (WPAI)
- Brief Cope
- Perceived Stress (PSS)
In addition, demographic assessments will be collected.
Read the detailed description
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").
- Conditions
- Stress
- Being tested
- Corporate Athlete® Resilience
- Keywords
- Stress, Resilience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corporate Athlete® ResilienceBehavioural
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:
- Introduction to stress and resilience: an overview of stress and its impact on wellbeing, combined with the definition of resilience and its linking to daily performance.
- Introduction and implementation of stress management and resilience techniques: an overview of applicable stress management and resilience tools, combined with real time application methods. These activities aim to help individuals recover and grow from a stressful state into meaningful life engagement. The desired overall effect is better performance at home and at work.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Corporate Athlete® Resilience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Mindset Measure-General (SMM-G)
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention (assessing for a change)
Energy Management Behaviors
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention (assessing for a change)
Qualitative Interviews
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.
Measured: 3-60 days post intervention
Secondary outcomes (7)
Brief Resilience Scale (BRS)
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention
Public Health Surveillance Wellbeing (PHS-WB)
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention
Sleep Habits (Rand MOS)
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention
Health, Wellbeing and Productivity (SF36, HPQ)
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention
Work Productivity and Activity Impairment (WPAI)
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.
Measured: between 3-weeks to the day of intervention for baseline, 1-month post intervention
Brief Cope
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention
Perceived Stress (PSS)
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.
Measured: 3-weeks to the day of intervention for baseline, 1-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start16 Sep 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To determine the impact of the Corporate Athlete® Resilience product through recalibrating mindset and changing resilience supportive behavior.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Health and Wellness Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lake Nona Institute, Grounded Solutions Ltd
- Responsible party
- Sponsor
- Investigators
- Shawn Mason, PhD, Principal investigator, Johnson & Johnson Health and Wellness Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451240
- Sponsor's protocol ID
- 2017-07A
- Status last verified
- Feb 2018
- First submitted
- 5 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Evaluation of HPI Resilience Intervention Study
- ClinicalTrials.gov ID
- NCT03451240
- Acronym / sponsor ID
- 2017-07A
- Conditions
- Stress
- Keywords
- Stress, Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johnson & Johnson Health and Wellness Solutions, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lake Nona Institute, Grounded Solutions Ltd
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Tool: Stress Mindset Measure-General (SMM-G)
Additional analysis will evaluate participants' engagement in behavior changes in the first 30 days.
- Tool: Energy Management Behaviors.
Secondary objectives include further analysis to determine if the intervention group demonstrated significant improvements in the following measures:
- Brief Resilience Scale (BRS)
- Public Health Surveillance Wellbeing (PHS-WB)
- Sleep Habits (Rand MOS)
- Health, Wellbeing and Productivity (SF36, HPQ)
- Work Productivity and Activity Impairment (WPAI)
- Brief Cope
- Perceived Stress (PSS)
In addition, demographic assessments will be collected.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To determine the impact of the Corporate Athlete® Resilience product through recalibrating mindset and changing resilience supportive behavior.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Corporate Athlete® Resilience |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be an adult (18 years or older);
- Be a participant in the LNLP (i.e., provided consent for the project);
- Meet =>2 stress experience level parameters on Stress Mindset Measure-General (SMM-G);
- Meet =< 4.3 on the Brief Resilience Scale (BRS);
- Be willing to attend a full day training program at the Lake Nona Institute during the designated training date;
Key exclusion criteria (7 listed)
- Is not an adult (18 years or older);
- Has not consented to participate in the LNLP;
- Does not meet the stress or resilience parameters (as defined above);
- Unwilling or unable to provide consent and sign the ICF;
- Unwilling or unable to complete study related questionnaires;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corporate Athlete® ResilienceThe 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: 1. Introduction to stress and resilience: an overview of stress and its impact on wellbeing, combined with the definition of resilience and its linking to daily performance. 2. Introduction and implementation of stress management and resilience techniques: an overview of applicable stress management and resilience tools, combined with real time application methods. These activities aim to help individuals recover and grow from a stressful state into meaningful life engagement. The desired overall effect is better performance at home and at work. | Behavioural | Intervention |
Primary outcome
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.
7 secondary outcomes
Brief Resilience Scale (BRS)
Time frame: 3-weeks to the day of intervention for baseline, 1-month post intervention
Public Health Surveillance Wellbeing (PHS-WB)
Time frame: 3-weeks to the day of intervention for baseline, 1-month post intervention
Sleep Habits (Rand MOS)
Time frame: 3-weeks to the day of intervention for baseline, 1-month post intervention
Health, Wellbeing and Productivity (SF36, HPQ)
Time frame: 3-weeks to the day of intervention for baseline, 1-month post intervention
Work Productivity and Activity Impairment (WPAI)
Time frame: between 3-weeks to the day of intervention for baseline, 1-month post intervention
Brief Cope
Time frame: 3-weeks to the day of intervention for baseline, 1-month post intervention
Perceived Stress (PSS)
Time frame: 3-weeks to the day of intervention for baseline, 1-month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Mason, PhD principal investigator
Johnson & Johnson Health and Wellness Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corporate Athlete® Resilience in people with Stress, run by Johnson & Johnson Health and Wellness Solutions, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.