Back to resultsThe WISER Study: Web Based Methods for Enhancing Resilience
Primary Purpose
Burnout
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WISER
Sponsored by
About this trial
This is an interventional treatment trial for Burnout focused on measuring Burnout, Well-being, Behavioral Health
Eligibility Criteria
Inclusion Criteria: Adults 18 and over are considered eligible for the study. A sub-sample will include employees (including but not limited to frontline caregivers, support staff and management) of the Duke University Health System, as well as external health systems. All participants will be invited to participate in one or more of the online tools. The investigators will allow the participation of any clinical areas/healthcare worker groups whose leaders express interest in building resilience. The investigators are targeting healthcare workers for recruitment in the study, but adults 18+ are eligible to participate in any of these tools. Identification as a healthcare worker or not is part of data collection in every tool. Exclusion Criteria: Adults who are not proficient in English, do not have basic computer skills, or who have prohibitive vision or hearing disabilities will be excluded from this study as they will be incapable of full participation in the intervention and/or the survey process.
Sites / Locations
- Duke University Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Immediately
Waitlist Control
Arm Description
Participants will engage in well-being tools immediately for 1-week.
Participants will wait 1 week to begin the well-being tools.
Outcomes
Primary Outcome Measures
Change in Emotional Exhaustion as measured by the 5-item Emotional Exhaustion Scale
Survey scores are measured on a 1-5 Likert-like agreement scale.
Secondary Outcome Measures
Change in Emotional Recovery as measured by the 4-item Emotional Recovery Scale
Survey scores are measured on a 1-5 Likert-like agreement scale.
Change in Work-life Integration as measured by the 7-item Work-life Integration Scale
Survey scores are measured with a 1-4 frequency of behaviors scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05636072
Brief Title
The WISER Study: Web Based Methods for Enhancing Resilience
Official Title
The WISER Study: Web Based Methods for Enhancing Resilience
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a research study to find out if web-based resilience tools can increase well-being.
Enrolled participants will try out one or more brief positive psychology tools. The tools ask participants to reflect on positive experiences or to do an activity (e.g., write a letter of gratitude). The study is entirely online and participants will be prompted to participate via email or text messages.
The study team is interested in the effects of the tools on stress, depression, and burnout in adults. A set of brief surveys are administered before and after using the tool, and again at follow-up periods (e.g., 1, 3, 6 and 12 months). Surveys are collected electronically using the secure, HIPAA compliant Qualtrics survey software.
There is no direct benefit to participants for participating in this research study aside from the potential to experience improvements in well-being. Risks are minimal and include the potential to feel emotional or psychological distress when asked questions related to burnout.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout
Keywords
Burnout, Well-being, Behavioral Health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Waitlist control group RCT
Masking
Participant
Allocation
Randomized
Enrollment
8000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Immediately
Arm Type
Experimental
Arm Description
Participants will engage in well-being tools immediately for 1-week.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Participants will wait 1 week to begin the well-being tools.
Intervention Type
Behavioral
Intervention Name(s)
WISER
Intervention Description
Participants will engage in one or more positive psychology well-being tool(s).
Primary Outcome Measure Information:
Title
Change in Emotional Exhaustion as measured by the 5-item Emotional Exhaustion Scale
Description
Survey scores are measured on a 1-5 Likert-like agreement scale.
Time Frame
Baseline, Day 8, and 1, 6, and 12 month follow-ups
Secondary Outcome Measure Information:
Title
Change in Emotional Recovery as measured by the 4-item Emotional Recovery Scale
Description
Survey scores are measured on a 1-5 Likert-like agreement scale.
Time Frame
Baseline, Day 8, and 1, 6, and 12 month follow-ups
Title
Change in Work-life Integration as measured by the 7-item Work-life Integration Scale
Description
Survey scores are measured with a 1-4 frequency of behaviors scale.
Time Frame
Baseline, Day 8, and 1, 6, and 12 month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults 18 and over are considered eligible for the study. A sub-sample will include employees (including but not limited to frontline caregivers, support staff and management) of the Duke University Health System, as well as external health systems. All participants will be invited to participate in one or more of the online tools. The investigators will allow the participation of any clinical areas/healthcare worker groups whose leaders express interest in building resilience. The investigators are targeting healthcare workers for recruitment in the study, but adults 18+ are eligible to participate in any of these tools. Identification as a healthcare worker or not is part of data collection in every tool.
Exclusion Criteria:
Adults who are not proficient in English, do not have basic computer skills, or who have prohibitive vision or hearing disabilities will be excluded from this study as they will be incapable of full participation in the intervention and/or the survey process.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John B Sexton, PhD
Phone
+1 919 681 4949
Email
bryan.sexton@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathryn C Adair, PhD
Phone
+1 919 681 4949
Email
Kathryn.C.Adair@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B Sexton, PhD
Organizational Affiliation
Duke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Bryan Sexton, PhD
Phone
919-681-4949
Email
Bryan.Sexton@duke.edu
First Name & Middle Initial & Last Name & Degree
Kathryn Adair, PhD
Phone
+1 919 681 4949
Email
Kathryn.C.Adair@duke.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only the research team will be accessing the data.
Citations:
PubMed Identifier
16045394
Citation
Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.
Results Reference
background
PubMed Identifier
34366432
Citation
Profit J, Adair KC, Cui X, Mitchell B, Brandon D, Tawfik DS, Rigdon J, Gould JB, Lee HC, Timpson WL, McCaffrey MJ, Davis AS, Pammi M, Matthews M, Stark AR, Papile LA, Thomas E, Cotten M, Khan A, Sexton JB. Randomized controlled trial of the "WISER" intervention to reduce healthcare worker burnout. J Perinatol. 2021 Sep;41(9):2225-2234. doi: 10.1038/s41372-021-01100-y. Epub 2021 Aug 9.
Results Reference
background
PubMed Identifier
34295357
Citation
Adair KC, Kennedy LA, Sexton JB. Three Good Tools: Positively reflecting backwards and forwards is associated with robust improvements in well-being across three distinct interventions. J Posit Psychol. 2020;15(5):613-622. doi: 10.1080/17439760.2020.1789707. Epub 2020 Jul 9.
Results Reference
background
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The WISER Study: Web Based Methods for Enhancing Resilience
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