Post-Traumatic Stress Disorder Clinical Trial
— CORALOfficial title:
Creative Arts Program to Reduce Burnout in Healthcare Professionals
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado - Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Endowment for the Arts, United States |
United States,
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04317820 -
Deep Brain Reorienting in Post-traumatic Stress Disorder
|
N/A | |
Completed |
NCT05112003 -
Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
|
N/A | |
Recruiting |
NCT04518267 -
Anger and Psychotrauma: Data From Military and Civilians
|
||
Completed |
NCT02502604 -
Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder
|
N/A | |
Terminated |
NCT02234687 -
A mGlu2/3 Agonist in the Treatment of PTSD
|
Phase 1 | |
Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
Completed |
NCT01738308 -
The Effects of Healing Touch on Post Operative Pediatric Patients
|
N/A | |
Terminated |
NCT02520726 -
PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
|
Phase 4 | |
Completed |
NCT02213900 -
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
|
Phase 4 | |
Completed |
NCT01517711 -
Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)
|
Phase 4 | |
Completed |
NCT01437891 -
Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)
|
N/A | |
Completed |
NCT01199107 -
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
|
Phase 3 | |
Completed |
NCT01998100 -
Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)
|
Phase 3 | |
Completed |
NCT01231711 -
Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention
|
Phase 1 | |
Completed |
NCT00348036 -
Group Intervention for Interpersonal Trauma
|
N/A | |
Completed |
NCT00680524 -
Telephone-based Care for OEF/OIF Veterans With PTSD
|
N/A | |
Completed |
NCT00838006 -
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
|
N/A | |
Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
Completed |
NCT00183690 -
Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents
|
Phase 1 | |
Completed |
NCT00127673 -
Comparison of Two Treatments for Post-Traumatic Stress Disorder
|
Phase 3 |