NCT04276922

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

4.8 years

First QC Date

January 30, 2020

Last Update Submit

December 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in subject perception of intervention process scores as assessed by Psychological General Well-Being Index (PGWBI).

    Baseline and after 12 weeks

  • Change in subject perception of intervention process scores as assessed by Positive and Negative Affect Schedule (PANAS).

    Baseline and after 12 weeks

  • Change in subject perception of intervention process scores as assessed by Maugeri Stress Index (MASI).

    Baseline and after 12 weeks

  • Change in perceived occupational stress as assessed by Medical Personnel Stress Survey (MPSS-R).

    Baseline and after 12 weeks

  • Change in perceived occupational stress as assessed by Job Content Questionnaire (JCQ).

    Baseline and after 12 weeks

  • +4 more secondary outcomes

Study Arms (5)

Visual Arts Group

EXPERIMENTAL

Visual Arts group - sketch journals

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.

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.

Behavioral: Dance/Movement

Writing/Poetry Group

EXPERIMENTAL

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

Behavioral: Writing/Poetry

Control Group

EXPERIMENTAL

Surveys at baseline and 12 weeks later.

Behavioral: Control

Interventions

Visual ArtsBEHAVIORAL

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.

Visual Arts Group
MusicBEHAVIORAL

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.

Music Group
Dance/MovementBEHAVIORAL

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.

Dance/Movement Group
Writing/PoetryBEHAVIORAL

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.

Writing/Poetry Group
ControlBEHAVIORAL

Control Group will only complete surveys at baseline and 12 weeks later.

Control Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unwillingness to participate in any of the four creative arts interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Burnout, PsychologicalStress Disorders, Post-TraumaticDepressionAnxiety Disorders

Interventions

Music TherapyMovement

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marc Moss, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 19, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2024

Study Completion

April 30, 2025

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations