AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers

Study Overview
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Brief Summary
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This research study is examining the feasibility and effectiveness of an online version of the Storytelling Through Music (STM) program with oncology nurses who have worked during the COVID-19 pandemic.

Detailed Description
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This study employs a two-group, randomized controlled trial design that will utilize quantitative and qualitative methods to evaluate the feasibility and intervention effect of an alternative delivery (online) of the Storytelling Through Music program (STM). Previous study of In-person delivery of Storytelling Through Music program STM with oncology nurses found it to be feasible and beneficial to coping with stress and work-related emotions. The research study procedures include: screening for eligibility and study intervention including follow-up surveys. Participants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid) STM group: Participants are led through a writing workshop over an online platform (i.e., Zoom or an equivalent) to develop their story. Simultaneous with the writing sessions are 10-minute self-care lessons. At the end of the development workshop, each participant will be paired with a songwriter who will turn participant stories into songs. A final workshop will be held for participants to debrief about the emotional experience of participating in the Storytelling Through Music program (STM) Waitlist control group (Storytelling Through Music-Hybrid), will listen to songs created by healthcare workers in the Storytelling Through Music program (STM) for 2 weeks. Participation length will be based on the randomized group assignment, a total of 19 weeks for the STM group and 13 weeks for the waitlist group. It is expected that about 50 people will take part in this research study.

Official Title
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An Arts-based Intervention With Healthcare Workers: Storytelling Through Music to Address Work Related Emotions (AWARENESS Trial)

Conditions
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Stress, Post Traumatic Stress Disorder, Work Related Stress

Intervention / Treatment
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* Behavioral: Storytelling Through Music (STM)
* Behavioral: Wait List / Storytelling Through Music-Hybrid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria for the study is as follows: a) >18 years old; b) licensed oncology nurse; c) provided direct patient care during COVID-19 pandemic. Exclusion Criteria: Key exclusion criteria include: a) have previously participated in the STM intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Storytelling Through Music (STM)<br>Participants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid) Storytelling Through Music (STM) group will participate in the study for a total of 19 weeks with 6 weeks of the STM program and 3 months follow up. Storytelling Through Music (STM) utilizes multiple modalities including storytelling, reflective writing, self-care skills (i.e., breathing exercises, meditation, self-compassion, body scans), and songwriting. Weeks 1-4: participants are led through weekly writing workshop over an online platform (i.e., Zoom or an equivalent) to develop their stories. Simultaneous with the writing sessions are 10-minute self-care lessons Week 5: Participants will be paired with a professional songwriter who will put their story into a song. Week 6: During the last week, participants will have one more writing workshop to debrief about the intervention. | Behavioral: Storytelling Through Music (STM)<br>* 6 week expressive arts-based program<br>|
| Experimental: Wait List / Storytelling Through Music-Hybrid<br>Participants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid) Waitlist control group (Storytelling Through Music-Hybrid) will participate in the study for a total of 13 weeks with 2 weeks of Storytelling Through Music-Hybrid program and 11 weeks of follow up . Storytelling Through Music-Hybrid involves participants listening to songs created for other healthcare professionals for 2 weeks. | Behavioral: Wait List / Storytelling Through Music-Hybrid<br>* 2 week song listening program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention | Primary endpoint is feasibility using visual analog scale Descriptive statistics will be used on the visual analog scale questions for analysis of feasibility. This intervention will be deemed feasible if 85% of the intervention is completed and 60% find it acceptable. | 6 weeks | 
| Acceptability of intervention | Additional primary endpoint is acceptability using descriptive qualitative data. Open-ended questions will prompt participants to provide insights into quantitative findings and the acceptability of the intervention. This intervention will be deemed feasible if 85% of the intervention is completed and 60% find it acceptable. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-awareness | Self-Reflection and Insight Scale; range is 12-72; higher score means better outcome. | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Post-traumatic stress | Impact of Event Scale-Revised; range is 0-88; lower score is better outcome. | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Self-compassion | Self-Compassion Scale; range is 26-130; higher score is better outcome. | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Anxiety | PROMIS Anxiety Scale (Short-form 6); range is 5-30; lower score is better outcome. | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Depression | PROMIS Depression Scale (Short-form 8); range is 8-40; lower score is better outcome. | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Insomnia | Insomnia Severity Index; range is 0-28; lower score is better outcome | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Loneliness | UCLA Loneliness Scale; range is 0-60; lower score is better outcome. | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Post-traumatic growth | Post-Traumatic Growth Index; range is 0-105; lower score is better outcome. | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 
| Professional Quality of Life | Professional Quality of Life Scale; 3 separate subscale scores=burnout (range is 10-50; lower score equals better outcome); Secondary traumatic stress (range is 10-50; lower score equals better outcome); Compassion satisfaction (range is 10-50; higher score equals better outcome). | 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Post Traumatic Stress Disorder, Work Related Stress