WELL Program for Caregiver Burnout

(WELL Trial)

Not currently recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado School of Public Health

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping early childhood education providers manage stress and improve well-being. It tests a program called WELL, which provides strategies for self-care and building better relationships with the children they teach. The trial aims to identify which aspects of the workplace most affect well-being and how the WELL program can make a difference. Head Start teachers in Colorado who care for young children might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to understanding and improving workplace well-being for educators.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the WELL program is safe for caregivers?

Research shows that the WELL program aims to help caregivers care for themselves and enhance their well-being. Although specific safety information for the WELL program is unavailable, similar programs that reduce stress and improve mental health for caregivers have been positively received. Participants in these programs often experience reduced stress, depression, and anxiety, and they report an improved quality of life.

This suggests that the WELL program might be safe and beneficial, even without direct safety data. The absence of safety concerns in similar programs is encouraging. Prospective participants should discuss any concerns with the study team before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WELL Program for caregiver burnout because it offers a fresh approach compared to traditional therapies like counseling or support groups. Unlike these standard methods, the WELL intervention focuses on implementing a structured, one-year program with three distinct strategies aimed at reducing burnout. This program is designed to be integrated into early childhood education centers, providing a unique support system directly where caregivers often experience stress. By embedding wellness strategies into caregivers' daily environments, the WELL Program has the potential to make a meaningful impact on reducing burnout more effectively than existing options.

What evidence suggests that the WELL program is effective for caregiver burnout?

Research has shown that programs like the WELL program, which participants in this trial may receive, include activities such as the Three Good Things and Gratitude Letter, and can boost well-being and reduce burnout in caregivers. Participants in similar programs have learned to solve problems more effectively and have improved their caregiving skills while experiencing less stress. These activities help caregivers understand their roles better and enhance their mental health. Physical exercise, often included in these programs, also reduces the stress and burden of caregiving. Overall, these strategies appear promising for improving the well-being of those who care for others. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for early childcare education providers who work at Head Start-funded centers in Colorado, caring for children aged 0-5. Participants must be at least 18 years old.

Inclusion Criteria

I work at a Head Start-funded center in Colorado, caring for children 0-5 years old.

Exclusion Criteria

N/A

Timeline for a Trial Participant

Control

ECE centers receive standard health promotion/professional development opportunities and usual care is documented

Varies by cohort

WELL Intervention

Implementation of the three-strategy WELL intervention begins, focusing on organization-level, interpersonal-level, and individual-level supports

1 year

Plan for Sustainability

Year allocated to plan for sustaining project infrastructures and activities with follow-up technical assistance

1 year

Sustaining WELL

First phase of withdrawal of research intervention support while maintaining support for research data collection

1 year

Observing Sustainability at a Distance

Withdrawal of all funding supports while observing the implementation and sustainability of WELL intervention

1 year

Follow-up

Participants are monitored for the effectiveness of the WELL intervention on well-being and other outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• WELL

Trial Overview The WELL program aims to help ECE providers focus on self-care and well-being, ensuring they can form stable relationships with the children they care for. The study will adapt and test the WELL program's effectiveness across various Head Start centers.

How Is the Trial Designed?

Group I: WELL intervention Experimental Treatment 1 Intervention

'WELL intervention' is when implementation of the one-year, three-strategy WELL intervention begins (see description).

Group II: Control Active Control 1 Intervention

In the stepped wedge design, ECE centers start the trial at the same point in time and act as controls with no intervention until they are randomized to crossover from control to intervention conditions.

Who Is Running the Clinical Trial?

Colorado School of Public Health

Lead Sponsor

Trials

13

Recruited

32,300+

Published Research Related to This Trial

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]

The 'Buddy Study' program, which includes a seminar and peer support for healthcare professionals after adverse events, received positive feedback from participants, with 91.6% satisfied with the seminar content and 69.1% feeling it helped them manage their emotional responses.

The program fostered a compassionate culture and attentiveness to colleagues' wellbeing, although it highlighted the need for ongoing support and visibility to maintain its effectiveness, suggesting that while valuable, peer support should complement other forms of support rather than replace them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of'the Buddy Study', a peer support program for second victims in healthcare: a survey in two Danish hospital departments. Schrøder, K., Bovil, T., Jørgensen, JS., et al.[2022]

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]

Three web-based interventions—Three Good Things, Gratitude Letter, and Looking Forward Tool—were tested in three studies involving a total of 521 healthcare workers, showing significant improvements in emotional exhaustion, depression, happiness, work-life balance, and emotional recovery after the interventions.

Despite some exceptions in long-term effects, these brief and engaging tools demonstrate promise in alleviating burnout among healthcare workers, highlighting the potential for simple self-care strategies to enhance well-being in this high-stress profession.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three Good Tools: Positively reflecting backwards and forwards is associated with robust improvements in well-being across three distinct interventions. Adair, KC., Kennedy, LA., Sexton, JB.[2021]

The Ohio State University Wexner Medical Center implemented a comprehensive, multiyear program starting in 2010 to reduce provider burnout and improve resilience, which included cultural change, mindfulness training, and wellness programs, resulting in improved patient satisfaction and reduced safety events.

Mindfulness training, particularly through the Mindfulness in Motion program and 'flipped classroom' approaches, significantly enhanced provider well-being, reduced emotional exhaustion, and increased resilience among staff, faculty, and residents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Reduce Burnout and Improve Resilience: Impact on a Health System's Outcomes. Moffatt-Bruce, SD., Nguyen, MC., Steinberg, B., et al.[2020]

An 8-month intervention in the Medical Oncology Department significantly reduced Emotional Exhaustion (EE) scores among health professionals, particularly in Day Hospital operators, indicating the effectiveness of structured support and reflection in combating burnout.

The study highlights that oncology healthcare workers are at high risk for burnout, emphasizing the need for targeted interventions and personal health strategies to be integrated into routine care to prevent and manage this syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burnout and Oncology: an irreparable paradigm or a manageable condition? Prevention strategies to reduce Burnout in Oncology Health Care Professionals. Bui, S., Pelosi, A., Mazzaschi, G., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3832864/

Improving caregiving competence, stress coping, and ... Study results supported the effectiveness of the CARERS Program in improving caregiving competence, stress coping ability and mental well-being in carers.

2. withpower.com withpower.com/trial/phase-caregiver-burden-10-2021-05ce4

WELL Program for Caregiver Burnout (WELL Trial) Research shows that interventions like the Three Good Things, Gratitude Letter, and Looking Forward tools can improve well-being and reduce burnout in ...

3. publichealth.gmu.edu publichealth.gmu.edu/news/2025-10/new-program-reduces-burnout-dementia-caregivers-novel-research-evaluation-proves

New program reduces burnout in dementia caregivers, novel ... Participants became more knowledgeable about ADRD, learned problem-solving strategies, improved their personal caregiving skills, reduced stress ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0883941724000633

Effectiveness of a health education program for people with ... This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11836036/

Effects of physical exercise in reducing caregivers burden The results suggest that physical exercise interventions are effective in reducing caregiver burden and stress, while also enhancing overall well-being.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424001030

Caregiver Wellness after Traumatic Brain Injury (CG-Well) A data safety monitoring board will be in place to review data quality control, queries, adverse events, and safety every six months. 3.1. Data analysis. 3.1 ...

7. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7334a2.htm

Changes in Health Indicators Among Caregivers This report compares changes in the prevalence of 19 health indicators among caregivers and noncaregivers from 2015–2016 to 2021–2022.

8. dshs.texas.gov dshs.texas.gov/alzheimers-disease/risk-reduction-promoting-cognitive-health/prevention/stress-busting-program

Stress-Busting Program for Family Caregivers | Texas DSHS Caregivers who have participated in this program have reported significantly lowered stress, depression, and anxiety as well as improved quality of life.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2791523/

Physical and Mental Health Effects of Family Caregiving Caregiving has all the features of a chronic stress experience: It creates physical and psychological strain over extended periods of time.