Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000471886
Ethics application status
Approved
Date submitted
22/01/2021
Date registered
21/04/2021
Date last updated
7/04/2024
Date data sharing statement initially provided
21/04/2021
Date results provided
21/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility, acceptability and preliminary effectiveness of an online mind-body resilience training program for management of symptoms of trauma related disorders amongst first responders
Scientific title
The feasibility, acceptability and preliminary effectiveness of an online mind-body resilience training program for management of symptoms of trauma related disorders amongst first responders
Secondary ID [1] 303243 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PTSD 320417 0
psychological distress 320418 0
Condition category
Condition code
Mental Health 318314 318314 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to ascertain the feasibility and acceptability of administering Online Tactical Resilience Training, a mind-body resilience training program developed by YogaShield® Yoga For First Responders® (YFFR). YogaShield® YFFR is a 501(c)(3) non-profit organization based in the United States that delivers in-person and online tactical yoga training to first responders.

The Online Tactical Resilience Training program is designed specifically for first responders and aims to provide proactive resilience training to first responders based on the foundation of traditional Hatha yoga, principles of Trauma-Sensitive yoga and uses a methodology that is job-specific and culturally informed. The online program will include modules on developing sustainable habits, foundations of Yoga for First Responders incorporating tactical breathwork and yoga techniques, processing stress and self-regulations strategies, building mental, physical, and emotional resilience, as well as enhancing job performance from decision-making to tactical skills. The program will also provide training on how to apply these techniques on and off the job.

The program will include pre-recorded lecture videos and audio materials, interactive exercises, pre-recorded yoga exercise videos, invitations to join a private Facebook group, access to a community forum via the online platform, as well as the option of attending live group Zoom classes with a YFFR instructor.

The program is designed to be completed within 6 weeks. However, participants will be given an additional 2 weeks to complete the course if they are unable to complete the course within then. Within these 6 weeks, participants are recommended to login to the online program on Day 1 of each week for a session that that is no longer than 1 hour. Days 2 to 7 of each week will comprise of homework videos no more than 30 minutes. There will also be an optional live zoom class facilitated by a YFFR instructor twice during the course. However, if participants are unable to attend the class at a predetermined time, a recording of the class will be made available, in which participants will be able to view at time that is more convenient to them. The educational material is a readily available resource from the Online Tactical Resilience Training, developed by YogaShield® Yoga For First Responders® (YFFR). To check that participants are adhering to the program, an automated reminder from the YFFR training platform will be sent 3 days from the first login to remind participants to continue with the course and to email YFFR support if they are encountering any technical difficulties with the course.
Intervention code [1] 319544 0
Behaviour
Comparator / control treatment
This pilot study uses a quantitative research methodology with a longitudinal cohort design using online self-report questionnaires. There will be no control group in the pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326281 0
1. Feasibility and acceptability – measure by usefulness of course components (measure developed by the researchers using likert scales), retention in study, adherence to sessions - assessed using data from program database
Timepoint [1] 326281 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Primary outcome [2] 326282 0
2. Symptoms of PTSD. • PTSD 8. Hansen, M., Andersen, T. E., Armour, C., Elklit, A., Palic, S., & Mackrill, T. (2010). PTSD-8: a short PTSD inventory. Clinical practice and epidemiology in mental health: CP & EMH, 6, 101.
Timepoint [2] 326282 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Primary outcome [3] 326283 0
symptoms of psychological distress. • K-6 Psychological Distress. Kessler, R. C., Green, J. G., Gruber, M. J., Sampson, N. A., Bromet, E., Cuitan, M., ... & Lara, C. (2010). Screening for serious mental illness in the general population with the K6 screening scale: results from the WHO World Mental Health (WMH) survey initiative. International journal of methods in psychiatric research, 19(S1), 4-22.
Timepoint [3] 326283 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Secondary outcome [1] 390894 0
Emotion Regulation • Emotion Regulation Questionnaire (ERQ). Gross, J.J., & John, O.P. (2003). Individual differences in two emotion regulation processes: Implications for affect, relationships, and well-being. Journal of Personality and Social Psychology, 85, 348-362.
Timepoint [1] 390894 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Secondary outcome [2] 390896 0
stress mindset. • Stress Mindset Questionnaire. Crum, A. J., Salovey, P., & Achor, S. (2013). Rethinking stress: The role of mindsets in determining the stress response. Journal of personality and social psychology, 104(4), 716.
Timepoint [2] 390896 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Secondary outcome [3] 390897 0
• Psychological Preparedness will be measured as a single tool by adapting the previously validated Psychologically preparedness for natural disasters scale to the first responders. Zulch, H. R., Reser, J. P., & Creed, P. (2012, November). Psychological preparedness for natural disasters. In Proceedings of the First International Conference on Urban Sustainability and Resilience, London, UK (pp. 5-6). McLennan, J., Marques, M. D., & Every, D. (2020). Conceptualising and measuring psychological preparedness for disaster: The Psychological Preparedness for Disaster Threat Scale. Natural Hazards, 101(1), 297-307.
Timepoint [3] 390897 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Secondary outcome [4] 390899 0
• Help-seeking will be measured using two self-report survey items developed by the researchers.
Timepoint [4] 390899 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Secondary outcome [5] 390903 0
• Work Performance will be measured using a single item from the Health and Work Performance Questionnaire (HPQ) (28) and two additional items pertaining to past month sickness absence.
Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, et al. The world health organization health and work performance questionnaire (HPQ). Journal of Occupational and Environmental Medicine. 2003;45(2):156-74.
Timepoint [5] 390903 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up
Secondary outcome [6] 390904 0
• COVID-19 Impact on Work (developed by researchers) will be measured using a self-report questionnaire
Timepoint [6] 390904 0
baseline, upon completion of training program (6-8 weeks after baseline), 3 month follow up

Eligibility
Key inclusion criteria

• 18 years of age or older
• Current active duty frontline first responders (including law enforcement, firefighters, paramedics, and dispatchers) currently residing in the United States
• English speaking
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/02/2021
Date of last participant enrolment
Anticipated
Actual
22/02/2021
Date of last data collection
Anticipated
18/10/2021
Actual
2/05/2021
Sample size
Target
55
Accrual to date
Final
58
Recruitment outside Australia
Country [1] 23400 0
United States of America
State/province [1] 23400 0

Funding & Sponsors
Funding source category [1] 307653 0
Charities/Societies/Foundations
Name [1] 307653 0
YogaShield® Yoga For First Responders®
Country [1] 307653 0
United States of America
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 308345 0
Charities/Societies/Foundations
Name [1] 308345 0
Black Dog Institute
Address [1] 308345 0
Black Dog Institute
Hospital Road,
Randwick NSW 2031
Country [1] 308345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307691 0
UNSW HREC
Ethics committee address [1] 307691 0
Ethics committee country [1] 307691 0
Australia
Date submitted for ethics approval [1] 307691 0
31/08/2020
Approval date [1] 307691 0
27/10/2020
Ethics approval number [1] 307691 0
HC200707

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108158 0
Prof Samuel B. Harvey
Address 108158 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 108158 0
Australia
Phone 108158 0
+61 293824517
Fax 108158 0
Email 108158 0
[email protected]
Contact person for public queries
Name 108159 0
Leona Tan
Address 108159 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 108159 0
Australia
Phone 108159 0
+61290659135
Fax 108159 0
Email 108159 0
[email protected]
Contact person for scientific queries
Name 108160 0
Leona Tan
Address 108160 0
Black Dog Institute,
Hospital Road
Randwick NSW 2031
Country 108160 0
Australia
Phone 108160 0
+61290659135
Fax 108160 0
Email 108160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.