Clinical trial NCT03451240: A Mixed Methods Evaluation of HPI Resilience Intervention Study
Official title: A Mixed Methods Evaluation of HPI Resilience Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress
Resilience
Lead sponsor: Johnson & Johnson Health and Wellness Solutions, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lake Nona Institute
name: Grounded Solutions Ltd
First posted: 2018-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To determine the impact of the Corporate Athlete® Resilience product through recalibrating mindset and changing resilience supportive behavior.
Primary purpose: OTHER

Brief 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.

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.

Detailed description: Methodology: This is an interventional mixed methods (qualitative \&amp; 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").

Eligibility criteria: Inclusion Criteria:

1. Be an adult (18 years or older);
2. Be a participant in the LNLP (i.e., provided consent for the project);
3. Meet =\>2 stress experience level parameters on Stress Mindset Measure-General (SMM-G);
4. Meet =\< 4.3 on the Brief Resilience Scale (BRS);
5. Be willing to attend a full day training program at the Lake Nona Institute during the designated training date;
6. Be willing to provide email and phone number as a contact method;
7. Must speak, read, and understand English fluently;
8. Be able to comprehend and follow the requirements of the study;
9. Research Participant must have a valid e-mail address;
10. Be able to provide Informed Consent;
11. Be willing and able to comply with all study procedures for the duration of the study.

Exclusion Criteria:

1. Is not an adult (18 years or older);
2. Has not consented to participate in the LNLP;
3. Does not meet the stress or resilience parameters (as defined above);
4. Unwilling or unable to provide consent and sign the ICF;
5. Unwilling or unable to complete study related questionnaires;
6. Have a physical or cognitive impairment that would interfere with their ability to provide accurate information;
7. Not able to speak, read, or understand English fluently.

Primary outcomes:
measure: Stress Mindset Measure-General (SMM-G)
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention (assessing for a change)
measure: Energy Management Behaviors
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention (assessing for a change)
measure: Qualitative Interviews
timeFrame: 3-60 days post intervention
Secondary outcomes:
measure: Brief Resilience Scale (BRS)
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention
measure: Public Health Surveillance Wellbeing (PHS-WB)
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention
measure: Sleep Habits (Rand MOS)
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention
measure: Health, Wellbeing and Productivity (SF36, HPQ)
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention
measure: Work Productivity and Activity Impairment (WPAI)
timeFrame: between 3-weeks to the day of intervention for baseline, 1-month post intervention
measure: Brief Cope
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention
measure: Perceived Stress (PSS)
timeFrame: 3-weeks to the day of intervention for baseline, 1-month post intervention
Other outcomes:
Locations:
city: Orlando
country: United States
facility: The Human Performance Institute
state: Florida
Study officials:
affiliation: Johnson & Johnson Health and Wellness Solutions
name: Shawn Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References: