WISER for Burnout

Overseen By Kathryn C Adair, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Non-English, No computer skills, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

8000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if web-based resilience tools can boost well-being by reducing stress, depression, and burnout. Participants will use brief positive psychology tools, such as reflecting on positive experiences or writing gratitude letters, all online. Two groups will participate: one begins using the tools immediately, while the other waits a week. This trial is ideal for adults, especially healthcare workers, who want to improve their resilience and often experience stress or burnout. As an unphased trial, this study provides a unique opportunity to explore innovative tools for enhancing personal well-being.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely since the study focuses on web-based resilience tools and surveys.

What prior data suggests that these web-based resilience tools are safe for improving well-being?

Research shows that the WISER program, which stands for Web-based Implementation for the Science of Enhancing Resilience, is generally safe for participants. Previous studies with healthcare workers found it effective in reducing emotional exhaustion and burnout, with no serious side effects reported.

The WISER program uses online tools to improve resilience and well-being. Participants engage in activities like reflecting on positive experiences or writing letters of gratitude. These gentle activities focus on positive emotions and are considered low risk.

However, a small chance exists that some people might feel emotional or upset when reflecting on their feelings or experiences, especially related to burnout. Overall, evidence suggests that WISER is well-tolerated, making it a safe option for those interested in joining the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WISER technique for burnout because it offers a fresh, immediate approach to improving well-being. Unlike traditional treatments that might involve long-term therapy or medication, WISER focuses on engaging participants with well-being tools over just one week, potentially providing fast relief. This method could revolutionize burnout management by delivering quick and practical tools for mental health enhancement, catering to the fast-paced lives of those affected by burnout.

What evidence suggests that the WISER intervention is effective for reducing burnout?

Research has shown that the WISER program can reduce emotional exhaustion and depression. In this trial, participants in the "Treatment Immediately" arm will use the WISER program's well-being tools for one week. A study with healthcare workers found that those who used WISER experienced better work-life balance and felt less burned out. Participants reported feeling less stressed and more resilient. The program includes online tools that focus on positive activities, such as gratitude exercises, which have been shown to improve well-being. While more research is needed for the general population, early results are promising for reducing stress and increasing overall happiness. ^{1 2 3 4 5}

Who Is on the Research Team?

John B Sexton, PhD

Principal Investigator

Duke

Are You a Good Fit for This Trial?

The WISER Study is for adults over 18, including healthcare workers from Duke University Health System and other health systems. It's aimed at those interested in using web-based tools to build resilience against stress, depression, and burnout.

Inclusion Criteria

The investigators will allow the participation of any clinical areas/healthcare worker groups whose leaders express interest in building resilience

I am over 18 years old and interested in participating in the study.

All participants will be invited to participate in one or more of the online tools

Exclusion Criteria

Adults who do not have basic computer skills

I am not proficient in English.

I have severe vision or hearing disabilities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in well-being tools immediately for 1 week

1 week

Online participation

Waitlist Control

Participants wait 1 week before beginning the well-being tools

1 week

Online participation

Follow-up

Participants are monitored for changes in emotional exhaustion, recovery, and work-life integration

12 months

Surveys at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• WISER

Trial Overview This study tests if online positive psychology tools can improve well-being by having participants engage in activities like writing gratitude letters. The effects are measured through surveys before, after, and up to 12 months post-use.

How Is the Trial Designed?

Group I: Treatment Immediately Experimental Treatment 1 Intervention

Participants will engage in well-being tools immediately for 1-week.

Group II: Waitlist Control Active Control 1 Intervention

Participants will wait 1 week to begin the well-being tools.

WISER is already approved in United States for the following indications:

Approved in United States as WISER for:

• Stress reduction
• Depression management
• Burnout prevention

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

The pilot study involving 66 doctoral students found that a brief, phone-administered behavioral intervention focused on approaching important goals significantly reduced burnout compared to a control group that only monitored their situation.

Participants in the approach intervention not only experienced lower burnout immediately after the intervention and at a 1-week follow-up, but also reported higher well-being, indicating the intervention's effectiveness and potential for remote delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study investigating the efficacy of brief, phone-based, behavioral interventions for burnout in graduate students. Fang, CM., McMahon, K., Miller, ML., et al.[2022]

A review of 18 studies found that low Neuroticism and high Extraversion are beneficial personality traits for nurses and paramedics, as they are linked to lower levels of burnout.

Nurses and paramedics exhibiting higher levels of Neuroticism and lower levels of Extraversion may be less suited for their roles, especially in high-stress situations, highlighting the importance of personality in occupational wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What personality types dominate among nurses and paramedics: A scoping review? Mason, R., Roodenburg, J., Williams, B.[2021]

A significant 79% of pediatricians reported experiencing adverse events, with 'missing a diagnosis' being the most emotionally impactful and 'aggressive behavior' the most common, leading to higher rates of mental health issues compared to the general population.

Only 26.3% of pediatricians had access to a peer support protocol for emotional support after adverse events, highlighting the need for structured support systems and education on coping strategies to improve their mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. van Steijn, ME., Scheepstra, KWF., Yasar, G., et al.[2020]

The WISER intervention significantly reduced burnout among healthcare workers, with a decrease of 5.27 points compared to a control group, indicating its efficacy in improving well-being.

Improvements in burnout, depression, and work-life integration were observed at both 1-month and 6-month follow-ups, suggesting that the benefits of the WISER program are durable over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of the "WISER" intervention to reduce healthcare worker burnout. Profit, J., Adair, KC., Cui, X., et al.[2023]

A 6-week mindfulness-based resilience training (MBRT) program significantly improved stress levels and emotional burnout among employees, while a smartphone-delivered intervention only enhanced overall well-being.

Both interventions were more effective than the control group, which showed no lasting improvements, highlighting the potential of targeted psychological interventions in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resilience Training for Work-Related Stress Among Health Care Workers: Results of a Randomized Clinical Trial Comparing In-Person and Smartphone-Delivered Interventions. Mistretta, EG., Davis, MC., Temkit, M., et al.[2019]

Physicians involved in adverse events often experience emotional distress, which significantly increases their risk of burnout, with an adjusted odds ratio of 1.90 for those affected.

Peer support is a crucial factor in reducing burnout among physicians after adverse events, as those who received such support had a lower risk of burnout (adjusted odds ratio of 0.65), highlighting the importance of fostering supportive environments in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multispecialty Physician Online Survey Reveals That Burnout Related to Adverse Event Involvement May Be Mitigated by Peer Support. Gupta, K., Rivadeneira, NA., Lisker, S., et al.[2023]

A second victim support intervention was implemented in a 500-bed University Hospital in Granada, Spain, providing structured emotional support to healthcare workers involved in serious adverse events (SAEs) over two years, with 135 workers receiving second-level support.

The intervention led to increased notification rates of SAEs and high acceptance among professionals, enhancing the visibility of support actions and contributing to a stronger culture of patient safety within the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Victim Support at the Core of Severe Adverse Event Investigation. Cobos-Vargas, A., Pérez-Pérez, P., Núñez-Núñez, M., et al.[2023]

A new inventory was developed to assess 12 distinct proactive burnout prevention behaviors among employees, based on a two-wave longitudinal survey involving 343 participants initially and 201 at follow-up.

The inventory demonstrated strong factorial validity and promising results for convergent, discriminant, and predictive validity, indicating it can effectively measure behaviors that help prevent burnout, although further research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development of a Proactive Burnout Prevention Inventory: How Employees Can Contribute to Reduce Burnout Risks. Otto, MCB., Van Ruysseveldt, J., Hoefsmit, N., et al.[2020]

The i-PARIHS framework effectively guided the implementation of patient-reported outcome measures (PROMs) in a medical oncology outpatient department, highlighting the importance of facilitation strategies to overcome barriers like time constraints and technology challenges.

Post-implementation surveys showed that staff perceived an increase in the usefulness and understanding of PROMs, although time limitations remained a significant barrier, indicating the need for dedicated facilitators during the implementation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of the implementation science framework "Integrated Promoting Action on Research Implementation in Health Services" (i-PARIHS) and the facilitator role for introducing patient-reported outcome measures (PROMs) in a medical oncology outpatient department. Roberts, NA., Janda, M., Stover, AM., et al.[2022]

The Patients First initiative uses the CareSense platform to combine patient-reported outcomes with biological monitoring, allowing for real-time feedback on symptoms like stress, anxiety, and depression, which enhances patient engagement and care delivery.

This project is pioneering in integrating digital therapeutics and providing video resources to primary care providers, enabling them to respond effectively when patients show signs of symptom severity, marking a significant advancement in psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Psychiatric Care Through Integrated Digital Technologies. Fowler, JC., Madan, A., Bruce, CR., et al.[2023]

The commentary emphasizes the importance of supporting surgeons' recovery after adverse events to enhance their well-being and performance.

It highlights that addressing the mental health and resilience of surgeons is crucial for maintaining high standards of patient care and surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary on supporting recovery after adverse events: An essential component of surgeon well-being. Langham, MR.[2021]

Over 6000 patients completed electronic Patient Reported Outcomes (e-PROs), achieving high completion rates (51%-95%) and demonstrating that e-PROs were well-accepted by both patients (76%) and clinicians (80%) for symptom communication and treatment planning.

The implementation of e-PROs led to significant reductions in anxiety levels and hospitalization rates, along with improved patient activation, indicating that integrating e-PROs in oncology practices can enhance patient management and reduce healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized symptom management: a quality improvement collaborative for implementation of patient reported outcomes (PROs) in 'real-world' oncology multisite practices. Howell, D., Rosberger, Z., Mayer, C., et al.[2020]

A survey of 61 healthcare providers and researchers revealed that having a dedicated PROM coordinator and integrating patient-reported outcome measures into electronic health records are key facilitators for successful implementation in clinical care.

Common barriers identified include language difficulties, IT issues, and time constraints, highlighting the need for healthcare organizations to address these challenges to enhance the use of PROMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and barriers for implementing patient-reported outcome measures in clinical care: An academic center's initial experience. Amini, M., Oemrawsingh, A., Verweij, LM., et al.[2022]

Implementing effective systems for monitoring patient-reported outcomes (PROs) in psychiatric care requires collaboration among various stakeholders, including clinicians and developers, rather than relying solely on technology.

The project revealed challenges in gaining consistent engagement from busy clinicians and administrators, highlighting the need for structured data prioritization to improve treatment effectiveness and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned while integrating patient-reported outcomes in a psychiatric hospital. Fowler, JC., Madan, A., Frueh, BC., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02603133

Web-based Implementation for the Science of Enhancing ... This study is designed to achieve the following aims: Test the effectiveness of WISER in improving NICU health professional resilience;; Test the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932377/

“WISER” intervention to reduce healthcare worker burnout The WISER intervention, a mobile program with six modules, reduced emotional exhaustion, depression, and improved work-life integration for healthcare workers ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.1016407/full

Effectiveness of a bite-sized web-based intervention to ... Objective: This study tested the effectiveness of the Web-based Implementation for the Science of Enhancing Resilience (WISER) intervention, a ...

4. nature.com nature.com/articles/s41372-021-01100-y

Randomized controlled trial of the “WISER” intervention to ... Our objective was to test the efficacy of WISER in improving NICU HCW burnout (primary outcome), depression, work-life integration, and happiness (secondary ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05636072

The WISER Study: Web Based Methods for Enhancing ... A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two ...