Burn-Out SyndromeCORALNCT04276922
Creative Arts Program to Reduce Burnout in Healthcare Professionals
A study testing Visual Arts, Music and Dance/Movement in people with Burn-Out Syndrome and Post-Traumatic Stress Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn if creative arts programs that include visual, musical, written, or physical expression can reduce symptoms of burnout syndrome, Post Traumatic Stress Disorder (PTSD), depression, and anxiety in critical care healthcare professionals. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn-Out Syndrome, Post-Traumatic Stress Disorder, Depression, Anxiety
- What is being tested?
- Visual Arts, Music and Dance/Movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed as a healthcare provider, practicing primarily in a hospital setting for at least 20 hours per week.
- Positive symptoms of burnout measured via the Maslach Burnout Inventory (MBI):
- emotional exhaustion score of >17, or
- depersonalization score of >7, or
- personal accomplishment score of < 31.
Who cannot join
- Unwillingness to participate in any of the four creative arts interventions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
Jeffrey McKeehan, MSN, 303-724-6080, jeffrey.mckeehan@ucdenver.edu
About this study
This study plans to learn if creative arts programs that include visual, musical, written, or physical expression can reduce symptoms of burnout syndrome, Post Traumatic Stress Disorder (PTSD), depression, and anxiety in critical care healthcare professionals. This study also explores if creative arts can enhance the connection to the purpose of work, the development of adequate coping skills, while providing time to connect with peers.
- Being tested
- Visual Arts, Music, Dance/Movement, Writing/Poetry, Control
- Medical subject headings
- Burnout, Psychological, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual ArtsBehavioural
Subjects meet for 90 minutes, once weekly, over 12 weeks for guided drawing/sketching sessions. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation.
MusicBehavioural
Subjects meet for 90 minutes, once weekly, over 12 weeks, for guided music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making. The 12 sessions follow a standard sequence, addressing three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
Surveys, activity diary cards are completed at baseline, weekly and at completion to assess satisfaction, stress, and well-being. Qualitative focus groups, after the intervention, assess acceptability of intervention, outcomes, program development and implementation.
Dance/MovementBehavioural
Subjects will meet once weekly, and begin with a movement check-in, a gentle physical warm-up, and then either a structured or improvisational movement process. for a total of 12 weeks. Each session will last 90 minutes. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation.
Writing/PoetryBehavioural
Subjects will meet once weekly, for writing workshops to encourage participants to tell the stories they need to tell, using integral elements of good writing, for a total of 12 weeks. Each session will last 90 minutes. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation.
ControlBehavioural
Control Group will only complete surveys at baseline and 12 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Visual Arts Group | Experimental | Visual Arts group - sketch journals Receives: Behavioral: Visual Arts |
| Music Group | Experimental | Music group involves music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making. Receives: Behavioral: Music |
| Dance/Movement Group | Experimental | Dance/Movement group - movement check-in, gentle physical warm-up, and then either a structured or improvisational movement process. Receives: Behavioral: Dance/Movement |
| Writing/Poetry Group | Experimental | Writing/Poetry group uses writing workshops using integral elements of good writing. Receives: Behavioral: Writing/Poetry |
| Control Group | Experimental | Surveys at baseline and 12 weeks later. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability/Satisfaction of Intervention as assessed by Client Satisfaction Questionnaire (CSQ-8) scores to yield a homogeneous estimate of general satisfaction.
Acceptability of intervention will be assessed using eight item Client Satisfaction Questionnaire (SCQ-8) to generate an estimate of general satisfaction. Scores range from 8-32 (higher scores = greater satisfaction).
Measured: At the end of 12 week intervention
Secondary outcomes (9)
Change in subject perception of intervention process scores as assessed by Psychological General Well-Being Index (PGWBI).
Emotional experience and sense of achievement using Psychological General Well-Being Index (PGWB), uses a 22-item survey to produce a single measure of psychological well-being.
Measured: Baseline and after 12 weeks
Change in subject perception of intervention process scores as assessed by Positive and Negative Affect Schedule (PANAS).
Positive and Negative Affect Schedule (PANAS) is a 20-item, self-report measure for changes in mood. Positive and negative affect (PA/NA) reflect dispositional dimensions - high-NA reflects subjective distress and unpleasable engagement, while high-PA represents pleasurable engagement, such as enthusiasm and alertness; low-PA reflects lethargy and sadness.
Measured: Baseline and after 12 weeks
Change in subject perception of intervention process scores as assessed by Maugeri Stress Index (MASI).
Maugeri Stress Index (MASI) is a self-report questionnaire. Four correlated sub scales (Wellness, Resilience, Perception of social support, and Negative coping styles). Total index is sum of responses (coded from 1 to 5). MASI-R score is expressed as a continuous variable: range: 0-100 , 50th percentile or less indicates presence of a stress condition) 118.
Measured: Baseline and after 12 weeks
Change in perceived occupational stress as assessed by Medical Personnel Stress Survey (MPSS-R).
Medical Personnel Stress Survey (MPSS-R) assesses key stressors on organizational and individual levels. Measures 4 components of occupational stress: organizational stress, job dissatisfaction, negative patient attitudes, somatic distress.
Measured: Baseline and after 12 weeks
Change in perceived occupational stress as assessed by Job Content Questionnaire (JCQ).
Job Content Questionnaire (JCQ) is scored on a 4-point Likert scale, covers 3 dimensions: Psychological Demand: 9 items evaluating amount of work demanded, rapidity required, time available, and level of concentration required. Decision Latitude: 9 items evaluating decision authority, use of skills, and varied aspects of tasks. Social support: 8 items evaluating help and interest provided by colleagues and supervisors.
Measured: Baseline and after 12 weeks
Change in perceived occupational stress as assessed by Turnover Intention Questionnaire (TIQ).
Turnover Intention Questionnaire (TIQ): 6 single-choice questions asking the respondents' intention to leave. Responses scored 1-4. High scores indicate high intention level to leave the profession. Total score of turnover intention is divided into four levels: lower ≤6, low >6 and ≤12, high >12 and ≤18, higher>18.
Measured: Baseline and after 12 weeks
Change in level of psychological distress as measured by Posttraumatic Diagnostic Scale (PDS).
Posttraumatic Diagnostic Scale (PDS) yields both a DSM-V diagnosis and symptom severity. Calculated by having a traumatic event, and a re-experiencing criterion, three avoidance symptoms, and two arousal symptoms.
Measured: Baseline and after 12 weeks
Change in level of psychological distress as measured by the Hospital Anxiety Depression Scale (HADS).
The Hospital Anxiety and Depression Scale (HADS) assesses 7-item anxiety subscale and a 7-item depression subscale. A score of > 8 identifies a positive history of anxiety or depression symptoms.
Measured: Baseline and after 12 weeks
Change in level of Burnout as measured by Maslach Burnout Inventory.
Maslach Burnout Inventory: Collected at baseline and post intervention.
Maslach Burnout Inventory (MBI) designates positive symptoms of burnout via three areas: emotional exhaustion score of >17, depersonalization score of >7, or a personal accomplishment score of < 31.
Measured: Baseline and after 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn-Out SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Responsible party
- Sponsor
- Investigators
- Marc Moss, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276922
- Sponsor's protocol ID
- 18-2759
- Other IDs
- NEAPS1801
- Acronym
- CORAL
- Status last verified
- Dec 2024
- First submitted
- 30 Jan 2020
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moss M, Edelblute A, Sinn H, Torres K, Forster J, Adams T, Morgan C, Henry M, Reed K. The Effect of Creative Arts Therapy on Psychological Distress in Health Care Professionals. Am J Med. 2022 Oct;135(10):1255-1262.e5. doi: 10.1016/j.amjmed.2022.04.016. Epub 2022 May 14.
PubMed 35576997
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creative Arts Program to Reduce Burnout in Healthcare Professionals
- ClinicalTrials.gov ID
- NCT04276922
- Acronym / sponsor ID
- CORAL / 18-2759
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn if creative arts programs that include visual, musical, written, or physical expression can reduce symptoms of burnout syndrome, Post Traumatic Stress Disorder (PTSD), depression, and anxiety in critical care healthcare professionals. This study also explores if creative arts can enhance the connection to the purpose of work, the development of adequate coping skills, while providing time to connect with peers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Visual Arts Group | Experimental | Behavioral: Visual ArtsVisual Arts group - sketch journals |
| Music Group | Experimental | Behavioral: MusicMusic group involves music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making. |
| Dance/Movement Group | Experimental | Behavioral: Dance/MovementDance/Movement group - movement check-in, gentle physical warm-up, and then either a structured or improvisational movement process. |
| Writing/Poetry Group | Experimental | Behavioral: Writing/PoetryWriting/Poetry group uses writing workshops using integral elements of good writing. |
| Control Group | Experimental | Behavioral: ControlSurveys at baseline and 12 weeks later. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Employed as a healthcare provider, practicing primarily in a hospital setting for at least 20 hours per week.
- Positive symptoms of burnout measured via the Maslach Burnout Inventory (MBI):
Key exclusion criteria (1 listed)
- Unwillingness to participate in any of the four creative arts interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual ArtsSubjects meet for 90 minutes, once weekly, over 12 weeks for guided drawing/sketching sessions. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community. Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation. | Behavioural | Visual Arts Group |
| MusicSubjects meet for 90 minutes, once weekly, over 12 weeks, for guided music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making. The 12 sessions follow a standard sequence, addressing three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community. Surveys, activity diary cards are completed at baseline, weekly and at completion to assess satisfaction, stress, and well-being. Qualitative focus groups, after the intervention, assess acceptability of intervention, outcomes, program development and implementation. | Behavioural | Music Group |
| Dance/MovementSubjects will meet once weekly, and begin with a movement check-in, a gentle physical warm-up, and then either a structured or improvisational movement process. for a total of 12 weeks. Each session will last 90 minutes. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community. Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation. | Behavioural | Dance/Movement Group |
| Writing/PoetrySubjects will meet once weekly, for writing workshops to encourage participants to tell the stories they need to tell, using integral elements of good writing, for a total of 12 weeks. Each session will last 90 minutes. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community. Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation. | Behavioural | Writing/Poetry Group |
| ControlControl Group will only complete surveys at baseline and 12 weeks later. | Behavioural | Control Group |
Primary outcome
Acceptability/Satisfaction of Intervention as assessed by Client Satisfaction Questionnaire (CSQ-8) scores to yield a homogeneous estimate of general satisfaction.
Time frame: At the end of 12 week intervention
Acceptability of intervention will be assessed using eight item Client Satisfaction Questionnaire (SCQ-8) to generate an estimate of general satisfaction. Scores range from 8-32 (higher scores = greater satisfaction).
9 secondary outcomes
Change in subject perception of intervention process scores as assessed by Psychological General Well-Being Index (PGWBI).
Time frame: Baseline and after 12 weeks
Change in subject perception of intervention process scores as assessed by Positive and Negative Affect Schedule (PANAS).
Time frame: Baseline and after 12 weeks
Change in subject perception of intervention process scores as assessed by Maugeri Stress Index (MASI).
Time frame: Baseline and after 12 weeks
Change in perceived occupational stress as assessed by Medical Personnel Stress Survey (MPSS-R).
Time frame: Baseline and after 12 weeks
Change in perceived occupational stress as assessed by Job Content Questionnaire (JCQ).
Time frame: Baseline and after 12 weeks
Change in perceived occupational stress as assessed by Turnover Intention Questionnaire (TIQ).
Time frame: Baseline and after 12 weeks
Change in level of psychological distress as measured by Posttraumatic Diagnostic Scale (PDS).
Time frame: Baseline and after 12 weeks
Change in level of psychological distress as measured by the Hospital Anxiety Depression Scale (HADS).
Time frame: Baseline and after 12 weeks
Change in level of Burnout as measured by Maslach Burnout Inventory.
Time frame: Baseline and after 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 35576997Moss M, Edelblute A, Sinn H, Torres K, Forster J, Adams T, Morgan C, Henry M, Reed K. The Effect of Creative Arts Therapy on Psychological Distress in Health Care Professionals. Am J Med. 2022 Oct;135(10):1255-1262.e5. doi: 10.1016/j.amjmed.2022.04.016. Epub 2022 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc Moss, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Arts, Music and Dance/Movement in people with Burn-Out Syndrome and Post-Traumatic Stress Disorder, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafaela Mantelli, BS (303-724-6377, rafaela.mantelli@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability/Satisfaction of Intervention as assessed by Client Satisfaction Questionnaire (CSQ-8) scores to yield a homogeneous estimate of general satisfaction. (time frame: At the end of 12 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.