search
Back to results

Creative Arts Program to Reduce Burnout in Healthcare Professionals (CORAL)

Primary Purpose

Burn-Out Syndrome, Post-Traumatic Stress Disorder, Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visual Arts
Music
Dance/Movement
Writing/Poetry
Control
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn-Out Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado - Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Visual Arts Group

Music Group

Dance/Movement Group

Writing/Poetry Group

Control Group

Arm Description

Visual Arts group - sketch journals

Music group involves music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making.

Dance/Movement group - movement check-in, gentle physical warm-up, and then either a structured or improvisational movement process.

Writing/Poetry group uses writing workshops using integral elements of good writing.

Surveys at baseline and 12 weeks later.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 30, 2020
Last Updated
October 12, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Endowment for the Arts, United States
search

1. Study Identification

Unique Protocol Identification Number
NCT04276922
Brief Title
Creative Arts Program to Reduce Burnout in Healthcare Professionals
Acronym
CORAL
Official Title
Creative Arts Program to Reduce Burnout in Healthcare Professionals
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Endowment for the Arts, United States

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn-Out Syndrome, Post-Traumatic Stress Disorder, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Visual Arts Group
Arm Type
Experimental
Arm Description
Visual Arts group - sketch journals
Arm Title
Music Group
Arm Type
Experimental
Arm Description
Music group involves music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making.
Arm Title
Dance/Movement Group
Arm Type
Experimental
Arm Description
Dance/Movement group - movement check-in, gentle physical warm-up, and then either a structured or improvisational movement process.
Arm Title
Writing/Poetry Group
Arm Type
Experimental
Arm Description
Writing/Poetry group uses writing workshops using integral elements of good writing.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Surveys at baseline and 12 weeks later.
Intervention Type
Behavioral
Intervention Name(s)
Visual Arts
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dance/Movement
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Writing/Poetry
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control Group will only complete surveys at baseline and 12 weeks later.
Primary Outcome Measure Information:
Title
Acceptability/Satisfaction of Intervention as assessed by Client Satisfaction Questionnaire (CSQ-8) scores to yield a homogeneous estimate of general satisfaction.
Description
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).
Time Frame
At the end of 12 week intervention
Secondary Outcome Measure Information:
Title
Change in subject perception of intervention process scores as assessed by Psychological General Well-Being Index (PGWBI).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in subject perception of intervention process scores as assessed by Positive and Negative Affect Schedule (PANAS).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in subject perception of intervention process scores as assessed by Maugeri Stress Index (MASI).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in perceived occupational stress as assessed by Medical Personnel Stress Survey (MPSS-R).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in perceived occupational stress as assessed by Job Content Questionnaire (JCQ).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in perceived occupational stress as assessed by Turnover Intention Questionnaire (TIQ).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in level of psychological distress as measured by Posttraumatic Diagnostic Scale (PDS).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in level of psychological distress as measured by the Hospital Anxiety Depression Scale (HADS).
Description
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.
Time Frame
Baseline and after 12 weeks
Title
Change in level of Burnout as measured by Maslach Burnout Inventory.
Description
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.
Time Frame
Baseline and after 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Torres, BS
Phone
303-724-6377
Email
kristen.torres@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey McKeehan, MSN
Phone
303-724-6080
Email
jeffrey.mckeehan@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Moss, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey McKeehan, MSN
Phone
303-724-6080
Email
jeffrey.mckeehan@ucdenver.edu

12. IPD Sharing Statement

Learn more about this trial

Creative Arts Program to Reduce Burnout in Healthcare Professionals

We'll reach out to this number within 24 hrs