Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001670864
Ethics application status
Approved
Date submitted
17/11/2021
Date registered
6/12/2021
Date last updated
7/04/2024
Date data sharing statement initially provided
6/12/2021
Date results provided
7/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster randomized controlled trial of a mind-body tactical resilience training in first responders
Scientific title
A cluster randomized controlled trial of a mind-body tactical resilience training in first responders
Secondary ID [1] 305828 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic stress 324356 0
Psychological distress 324357 0
Somatic symptoms 324358 0
Condition category
Condition code
Mental Health 321842 321842 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Mind-Body Tactical Resilience Training Program is developed by YogaShield® Yoga For First Responders® (YFFR). YogaShield® YFFR is a non-profit organization based in Colorado, United States that delivers this tactical resilience training to first responders using mind-body techniques that are job-specific and culturally informed. Members of the organisation consist of active and former first responders, military, as well as yoga instructors. The aim of this training is to equip first responders with a proactive and tactical skillset for processing stress, building resilience, and enhancing performance using a methodology that is job specific and culturally informed. To the best of our knowledge, this is the most well-established tactical mind-body resilience training program for first responders in the world. Given the scale and reach that the organisation has already achieved with local networks as well as throughout the U.S. and internationally, collaborating with YFFR and their first responder networks in the U.S. is an ideal location to undertake analysis on the effectiveness of this type of training.

The Mind-Body Tactical Resilience Training consists of a free-of-charge program comprising sixteen 60-minute classes delivered between approximate 8 - 16 weeks (depending on shift schedules) by trained YFFR instructors, and within the department’s training facility. The aim of this training is to equip first responders with a proactive and tactical skillset for processing stress, building resilience, and enhancing performance using a methodology that is job specific and culturally informed. The training utilizes a variety of specialized techniques including tactical breathwork, physical drills, mindfulness and self-regulation strategies. Classes will be scheduled with each department’s training chief to ensure accessibility for participants to attend as many in-person classes as possible. Adherence will be monitored using attendance records.
Intervention code [1] 322221 0
Prevention
Comparator / control treatment
Waitlist-control group.

The waitlist-control group will receive the same intervention after a 3 month delay.
Control group
Active

Outcomes
Primary outcome [1] 329596 0
Post-traumatic stress symptoms as measured by PTSD-8
Timepoint [1] 329596 0
a) Pre-intervention
b) Post-intervention (within 1 week of completion of the training program)
c) 3 month follow up
Primary outcome [2] 329597 0
Psychological distress as measured by the K-6
Timepoint [2] 329597 0
a)Pre-intervention
b)Post-intervention (within 1 week of completion of the training program)
c) 3 month follow-up
Secondary outcome [1] 403123 0
Short Form Perceived Stress Scale (PSS-4)
Timepoint [1] 403123 0
a)Pre-intervention
b)Post-intervention (within 1 week of completion of the training program)
c) 3 month follow-up
Secondary outcome [2] 403125 0
Somatic symptoms (Abbreviated PHQ-15 scale)
Timepoint [2] 403125 0
a)Pre-intervention
b)Post-intervention (within 1 week of completion of the training program)
c) 3 month follow-up
Secondary outcome [3] 403126 0
Resilience (Brief Resilience Scale)
Timepoint [3] 403126 0
a)Pre-intervention
b)Post-intervention (within 1 week of completion of the training program)
c) 3 month follow-up
Secondary outcome [4] 403127 0
Emotion regulation (ERQ scale)
Timepoint [4] 403127 0
a)Pre-intervention
b)Post-intervention (within 1 week of completion of the training program)
c) 3 month follow-up
Secondary outcome [5] 403128 0
Stress mindset (SMM questionnaire)
Timepoint [5] 403128 0
a)Pre-intervention
b)Post-intervention (within 1 week of completion of the training program)
c) 3 month follow-up
Secondary outcome [6] 403129 0
Work performance (Health and Work Performance Questionnaire (HPQ)
Timepoint [6] 403129 0
a)Pre-intervention
b)Post-intervention (within 1 week of completion of the training program)
c) 3 month follow-up

Eligibility
Key inclusion criteria
• 18 years of age or older
• Current active-duty and operational 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?
Yes
Key exclusion criteria
• Individuals not a currently working (paid or volunteer) as an active-duty frontline first responder (law enforcement, firefighters, paramedics or dispatcher)
• Non-operational staff
• Previous participation in a Yoga for First Responders® training program

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analyses will be undertaken within an intention-to-treat framework, retaining all participants as randomised regardless of extent of engagement with training or withdrawal from the study. Likelihood based methods (mixed-model repeated measures (MMRM) will be used to assess significance of change in the primary outcome measures. Clustering of each shift of participants will be accounted for by a random cluster membership factor, and an unstructured variance–covariance matrix will be used to accommodate the relationships between observations at the three different measurement timepoints, from baseline (T1) to the final 3-month follow up (T3). Stratification variables and any variables found to be substantially imbalanced between intervention arms post randomisation will be tentatively included in these models and retained if statistically significant and influential on outcomes. Additional per-protocol analysis using data for those who successful complete baseline and the follow-up assessments will also be conducted.

Secondary analyses will also include, but are not limited to, controlling for baseline symptoms to measure differential intervention effects, as well as analyses of secondary outcomes assessing differential change due to the intervention arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2022
Actual
2/03/2022
Date of last participant enrolment
Anticipated
14/02/2022
Actual
31/03/2022
Date of last data collection
Anticipated
31/07/2022
Actual
31/12/2022
Sample size
Target
100
Accrual to date
Final
92
Recruitment outside Australia
Country [1] 24330 0
United States of America
State/province [1] 24330 0
Colorado

Funding & Sponsors
Funding source category [1] 310178 0
Government body
Name [1] 310178 0
National Health and Medical Research Council Investigator Grant
Country [1] 310178 0
Australia
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] 311265 0
Charities/Societies/Foundations
Name [1] 311265 0
Black Dog Institute
Address [1] 311265 0
Hospital Road
Black Dog Institute
Randwick 2031
New South Wales
Country [1] 311265 0
Australia
Other collaborator category [1] 282072 0
Charities/Societies/Foundations
Name [1] 282072 0
YogaShield® Yoga For First Responders® (YFFR)
Address [1] 282072 0
834-F S Perry Street #1191 | Castle Rock, CO 80104, USA
Country [1] 282072 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309864 0
UNSW HREC Executive
Ethics committee address [1] 309864 0
Ethics committee country [1] 309864 0
Australia
Date submitted for ethics approval [1] 309864 0
05/10/2021
Approval date [1] 309864 0
02/12/2021
Ethics approval number [1] 309864 0
HC210832

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

Contacts
Principal investigator
Name 115654 0
Prof Samuel B. Harvey
Address 115654 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 115654 0
Australia
Phone 115654 0
+61 2 9382 8356
Fax 115654 0
Email 115654 0
[email protected]
Contact person for public queries
Name 115655 0
Leona Tan
Address 115655 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 115655 0
Australia
Phone 115655 0
+61 2 9065 9135
Fax 115655 0
Email 115655 0
[email protected]
Contact person for scientific queries
Name 115656 0
Samuel B. Harvey
Address 115656 0
Black Dog Institute
Hospital Road
Randwick 2031
NSW
Country 115656 0
Australia
Phone 115656 0
+61 2 9382 8356
Fax 115656 0
Email 115656 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
SourceTitleYear of PublicationDOI
EmbaseAdaptive and Maladaptive Cognitive-Emotional Strategies Associated With PTSD in First Responders: A Cross-Sectional Study.2023https://dx.doi.org/10.1097/JOM.0000000000002829
N.B. These documents automatically identified may not have been verified by the study sponsor.