- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04276922
Creative Arts Program to Reduce Burnout in Healthcare Professionals (CORAL)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristen Torres, BS
- Phone Number: 303-724-6377
- Email: kristen.torres@cuanschutz.edu
Study Contact Backup
- Name: Jeffrey McKeehan, MSN
- Phone Number: 303-724-6080
- Email: jeffrey.mckeehan@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado - Anschutz Medical Campus
-
Contact:
- Jeffrey McKeehan, MSN
- Phone Number: 303-724-6080
- Email: jeffrey.mckeehan@ucdenver.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Unwillingness to participate in any of the four creative arts interventions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Visual Arts Group
Visual Arts group - sketch journals
|
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. |
Experimental: Music Group
Music group involves music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making.
|
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. |
Experimental: Dance/Movement Group
Dance/Movement group - movement check-in, gentle physical warm-up, and then either a structured or improvisational movement process.
|
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. |
Experimental: Writing/Poetry Group
Writing/Poetry group uses writing workshops using integral elements of good writing.
|
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. |
Experimental: Control Group
Surveys at baseline and 12 weeks later.
|
Control Group will only complete surveys at baseline and 12 weeks later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
At the end of 12 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in subject perception of intervention process scores as assessed by Psychological General Well-Being Index (PGWBI).
Time Frame: Baseline and after 12 weeks
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline and after 12 weeks
|
Change in perceived occupational stress as assessed by Job Content Questionnaire (JCQ).
Time Frame: Baseline and after 12 weeks
|
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.
|
Baseline and after 12 weeks
|
Change in perceived occupational stress as assessed by Turnover Intention Questionnaire (TIQ).
Time Frame: Baseline and after 12 weeks
|
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.
|
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
|
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.
|
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
|
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.
|
Baseline and after 12 weeks
|
Change in level of Burnout as measured by Maslach Burnout Inventory.
Time Frame: Baseline and after 12 weeks.
|
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. |
Baseline and after 12 weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc Moss, MD, University of Colorado, Denver
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-2759
- NEAPS1801 (Other Grant/Funding Number: National Endowment for the Arts)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Depression, Anxiety
-
University Hospital, Strasbourg, FranceCompletedAnxiety Depression DisorderFrance
-
ViomeRecruitingDepression | Anxiety Disorders | Anxiety | Mental Health Disorder | Anxiety Depression | Anxiety State | Mental Health | Depression, Anxiety | Mental Health IssueUnited States
-
3-C Institute for Social DevelopmentUniversity of Miami; Stony Brook UniversityCompletedDepression | Anxiety | Depression, Anxiety | Depression in AdolescenceUnited States
-
University Hospital, Strasbourg, FranceRecruitingDepression Anxiety DisorderFrance
-
UCLH/UCL Joint Research OfficeMedical Research Council; Camden and Islington NHS Trust; Central and North West...RecruitingAnxiety Disorders | Anxiety | Anxiety Depression | CBT | Anxiety Disorders and Symptoms | Anxiety Generalized | Generalised Anxiety Disorder | Anxiety Disorder; Mixed With Depression (Mild) | Anxiety Disorder GeneralizedUnited Kingdom
-
University of Southern CaliforniaCompletedAnxiety | Depression, Anxiety | Depression Mild | Attention Concentration DifficultyUnited States
-
Laureate Institute for Brain Research, Inc.National Institute of Mental Health (NIMH); California Institute of TechnologyRecruitingDepression | Anxiety Disorders | Fear | Depression, Anxiety | Anxiety and Fear | Anxious DepressionUnited States
-
NeuroGlove LLCRecruitingDepression | Anxiety | Anxiety Depression | Depression, AnxietyUnited States
-
San Diego State UniversityKaiser Permanente; OCHIN, Inc.Not yet recruiting
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Not yet recruitingDepression | Anxiety Disorders | Anxiety | Depression, Anxiety
Clinical Trials on Visual Arts
-
NYU Langone HealthNational Library of Medicine (NLM)Completed
-
The Nethersole School of NursingNot yet recruitingStroke | Psychosocial Problem
-
Aix Marseille UniversitéUniversity of Roma La Sapienza; WHO Collaborating Centre for Maternal and Child...CompletedReading Disability
-
School of Health Sciences GenevaUniversity of Lausanne Hospitals; University of Geneva, SwitzerlandRecruitingMagnetic Resonance Imaging | Behavior | Functional Magnetic Resonance Imaging | Music | Development, Child | Brain Imaging | Executive Functions | Brain Plasticity | Interventions | Arts | Structural Brain ConnectivitySwitzerland
-
Dartmouth-Hitchcock Medical CenterNational Endowment for the Arts, United StatesCompleted
-
The Royal Conservatory of MusicOntario Trillium FoundationUnknownPatient Engagement | Social Wellness Through Engagement in a Creative ProcessCanada
-
Allorion Therapeutics IncRecruitingChinese Healthy VolunteerChina
-
William Marsh Rice UniversityNational Endowment for the Arts, United States; Methodist Research Institute... and other collaboratorsUnknown