- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636072
The WISER Study: Web Based Methods for Enhancing Resilience
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 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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John B Sexton, PhD
- Phone Number: +1 919 681 4949
- Email: bryan.sexton@duke.edu
Study Contact Backup
- Name: Kathryn C Adair, PhD
- Phone Number: +1 919 681 4949
- Email: Kathryn.C.Adair@duke.edu
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27707
- Recruiting
- Duke University Health System
-
Contact:
- J. Bryan Sexton, PhD
- Phone Number: 919-681-4949
- Email: Bryan.Sexton@duke.edu
-
Contact:
- Kathryn Adair, PhD
- Phone Number: +1 919 681 4949
- Email: Kathryn.C.Adair@duke.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Immediately
Participants will engage in well-being tools immediately for 1-week.
|
Participants will engage in one or more positive psychology well-being tool(s).
|
No Intervention: Waitlist Control
Participants will wait 1 week to begin the well-being tools.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Emotional Exhaustion as measured by the 5-item Emotional Exhaustion Scale
Time Frame: Baseline, Day 8, and 1, 6, and 12 month follow-ups
|
Survey scores are measured on a 1-5 Likert-like agreement scale.
|
Baseline, Day 8, and 1, 6, and 12 month follow-ups
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Emotional Recovery as measured by the 4-item Emotional Recovery Scale
Time Frame: Baseline, Day 8, and 1, 6, and 12 month follow-ups
|
Survey scores are measured on a 1-5 Likert-like agreement scale.
|
Baseline, Day 8, and 1, 6, and 12 month follow-ups
|
Change in Work-life Integration as measured by the 7-item Work-life Integration Scale
Time Frame: Baseline, Day 8, and 1, 6, and 12 month follow-ups
|
Survey scores are measured with a 1-4 frequency of behaviors scale.
|
Baseline, Day 8, and 1, 6, and 12 month follow-ups
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John B Sexton, PhD, Duke
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00063703
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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