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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04775524
• Other study ID #: 20-710
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occupational Stress
• Post Traumatic Stress Disorder
• Stress
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Work Related Stress

Intervention

Behavioral:
• Storytelling Through Music (STM)
6 week expressive arts-based program
• Wait List / Storytelling Through Music-Hybrid
2 week song listening program

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)