Creative Arts Program to Reduce Burnout in Healthcare Professionals

Post-Traumatic Stress Disorder Clinical Trial

— CORAL  

Official title:

Creative Arts Program to Reduce Burnout in Healthcare Professionals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276922
• Other study ID #: 18-2759
• Secondary ID: NEAPS1801
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: Kristen Torres, BS
• Phone: 303-724-6377
• Email: kristen.torres[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn-Out Syndrome
• Burnout, Psychological
• Depression, Anxiety
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Visual Arts
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.
• Music
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/Movement
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/Poetry
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.
• Control
Control Group will only complete surveys at baseline and 12 weeks later.

Locations

Country	Name	City	State
United States	University of Colorado - Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Endowment for the Arts, United States

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At the end of 12 week intervention
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks
Secondary	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.	Baseline and after 12 weeks.