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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05636072
Other study ID # Pro00063703
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Duke University
Contact John B Sexton, PhD
Phone +1 919 681 4949
Email bryan.sexton@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
WISER
Participants will engage in one or more positive psychology well-being tool(s).

Locations

Country Name City State
United States Duke University Health System Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, Day 8, and 1, 6, and 12 month follow-ups
Secondary 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. Baseline, Day 8, and 1, 6, and 12 month follow-ups
Secondary 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. Baseline, Day 8, and 1, 6, and 12 month follow-ups
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