A Mixed Methods Evaluation of HPI Resilience Intervention Study

NCT03451240 | Completed

• 1 other identifier: 2017-07A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Stress; Resilience

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  3-60 days post intervention

Secondary Outcomes (7)

• Brief Resilience Scale (BRS)

  3-weeks to the day of intervention for baseline, 1-month post intervention

• Public Health Surveillance Wellbeing (PHS-WB)

  3-weeks to the day of intervention for baseline, 1-month post intervention

• Sleep Habits (Rand MOS)

  3-weeks to the day of intervention for baseline, 1-month post intervention

• Health, Wellbeing and Productivity (SF36, HPQ)

  3-weeks to the day of intervention for baseline, 1-month post intervention

• Work Productivity and Activity Impairment (WPAI)

  between 3-weeks to the day of intervention for baseline, 1-month post intervention

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: Corporate Athlete® Resilience

Interventions

Corporate Athlete® Resilience BEHAVIORAL

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: 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Health and Wellness Solutions, Inc.: lead
• Lake Nona Institute: collaborator
• Grounded Solutions Ltd: collaborator

Study Sites (1)

The Human Performance Institute

Orlando, Florida, 32827, United States

Location

Study Officials

• Shawn Mason, PhD

  Johnson & Johnson Health and Wellness Solutions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To determine the impact of the Corporate Athlete® Resilience product through recalibrating mindset and changing resilience supportive behavior.

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 1, 2018
• Study Start: September 16, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

US (1)