[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04276922":3,"trial-entities:NCT04276922":139,"trial-summary:NCT04276922":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":55,"secondary_outcomes":60,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":93,"eligibility_criteria":94,"std_ages":103,"locations":106,"central_contacts":122,"overall_officials":129,"references":133,"see_also_links":138},"NCT04276922","18-2759","Creative Arts Program to Reduce Burnout in Healthcare Professionals","RECRUITING","2025-04-30","2024-12","2024-12-16","2020-03-01","University of Colorado, Denver","OTHER",null,"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.",[17,18,19],"Burn-Out Syndrome","Post-Traumatic Stress Disorder","Depression, Anxiety",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},195,"ESTIMATED",[29,35,40,45,50],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Visual Arts","Subjects meet for 90 minutes, once weekly, over 12 weeks for guided drawing\u002Fsketching sessions. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.\n\nSurveys, 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.",[34],"Visual Arts Group",{"type":30,"name":36,"description":37,"armGroupLabels":38},"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\u002For 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.\n\nSurveys, 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.",[39],"Music Group",{"type":30,"name":41,"description":42,"armGroupLabels":43},"Dance\u002FMovement","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.\n\nSurveys, 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.",[44],"Dance\u002FMovement Group",{"type":30,"name":46,"description":47,"armGroupLabels":48},"Writing\u002FPoetry","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.\n\nSurveys, 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.",[49],"Writing\u002FPoetry Group",{"type":30,"name":51,"description":52,"armGroupLabels":53},"Control","Control Group will only complete surveys at baseline and 12 weeks later.",[54],"Control Group",[56],{"measure":57,"description":58,"timeFrame":59},"Acceptability\u002FSatisfaction 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",[61,65,68,71,74,77,80,83,86],{"measure":62,"description":63,"timeFrame":64},"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",{"measure":66,"description":67,"timeFrame":64},"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\u002FNA) 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.",{"measure":69,"description":70,"timeFrame":64},"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.",{"measure":72,"description":73,"timeFrame":64},"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.",{"measure":75,"description":76,"timeFrame":64},"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.",{"measure":78,"description":79,"timeFrame":64},"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.",{"measure":81,"description":82,"timeFrame":64},"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.",{"measure":84,"description":85,"timeFrame":64},"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.",{"measure":87,"description":88,"timeFrame":89},"Change in level of Burnout as measured by Maslach Burnout Inventory.","Maslach Burnout Inventory: Collected at baseline and post intervention.\n\nMaslach 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 \\\u003C 31.","Baseline and after 12 weeks.","ALL","18 Years","85 Years",true,{"inclusion":95,"exclusion":101,"raw_text":102},[96,97,98,99,100],"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 \\\u003C 31.",[],"Inclusion Criteria:\n\n* Employed as a healthcare provider, practicing primarily in a hospital setting for at least 20 hours per week.\n* Positive symptoms of burnout measured via the Maslach Burnout Inventory (MBI):\n\n  * emotional exhaustion score of \\>17, or\n  * depersonalization score of \\>7, or\n  * personal accomplishment score of \\\u003C 31.\n\nExclusion Criteria:\n\n• Unwillingness to participate in any of the four creative arts interventions.",[104,105],"ADULT","OLDER_ADULT",[107],{"facility":108,"status":7,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":119},"University of Colorado - Anschutz Medical Campus","Aurora","Colorado","80045","United States",[114],{"name":115,"role":116,"phone":117,"email":118},"Jeffrey McKeehan, MSN","CONTACT","303-724-6080","jeffrey.mckeehan@ucdenver.edu",{"lat":120,"lon":121},39.72943,-104.83192,[123,127],{"name":124,"role":116,"phone":125,"email":126},"Rafaela Mantelli, BS","303-724-6377","rafaela.mantelli@cuanschutz.edu",{"name":115,"role":116,"phone":117,"email":128},"jeffrey.mckeehan@cuanschutz.edu",[130],{"name":131,"affiliation":12,"role":132},"Marc Moss, MD","PRINCIPAL_INVESTIGATOR",[134],{"pmid":135,"type":136,"citation":137},"35576997","DERIVED","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\u002Fj.amjmed.2022.04.016. Epub 2022 May 14.",[],{"nct_id":4,"conditions":140,"biomarkers":144},[141,142,143,18],"Anxiety","Burnout, Psychological","Depression",[],{"nct_id":4,"found":93,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This interventional study plans to enroll 195 participants. It compares different creative arts programs to a control group that only completes surveys.","completed","Creative Arts Program for Healthcare Professional Burnout","This study is looking into whether creative arts programs can help healthcare professionals who are experiencing burnout, Post-Traumatic Stress Disorder (PTSD), depression, and anxiety. You could participate in guided sessions focusing on visual arts, music, dance\u002Fmovement, or writing\u002Fpoetry. These sessions aim to help you connect with your work's purpose, develop coping skills, and connect with peers. To join, you must be a healthcare provider working at least 20 hours per week in a hospital setting and show specific signs of burnout based on a questionnaire. The study will measure how satisfied participants are with the creative arts programs after 12 weeks. The current status of this study is unclear.","Your satisfaction with the intervention will be assessed at the end of the 12-week intervention.",109,"If you participate, you would attend weekly 90-minute creative arts sessions for 12 weeks, or complete surveys at the beginning and end of 12 weeks if in the control group.","Not stated in the trial record.",[31,36,41,46],"v2"]