Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000101482
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
30/01/2025
Date last updated
30/01/2025
Date data sharing statement initially provided
30/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effectiveness of Breathwork on increasing resilience and psychological well-
being while preventing and attenuating anxiety, depression, insomnia, and stress in emergency responders
Scientific title
Examining the effectiveness of Breathwork on increasing resilience and psychological well-
being while preventing and attenuating anxiety, depression, insomnia, and stress in emergency responders
Secondary ID [1] 313545 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 336033 0
Depression 336298 0
Stress 336299 0
Insomnia 336300 0
Resilience 336301 0
Psychological Wellbeing 336302 0
Condition category
Condition code
Mental Health 332598 332598 0 0
Anxiety
Mental Health 332599 332599 0 0
Depression
Mental Health 332600 332600 0 0
Other mental health disorders
Neurological 332834 332834 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the study, the most appropriate study design is a pragmatic mixed methods single-blinded RCT. The experimental design will use deductive reasoning, intervention, and survey strategies, and be longitudinal spanning 12 weeks. It will use a variety of validated and reliable self-questionnaires to examine the effectiveness of the interventions. This RCT will have 2 groups: a) control group, and b) Breathwork group.

The sampling frame will include paramedicine students from a) Victoria University, b) Monash University, c) ACU, and d) La Trobe. 160 subjects in total will be recruited in cooperation with their governing organisations. Informed consent will be obtained from all participating subjects with the ability to withdraw at any time.
Inclusion Criteria: subjects (aged 18-99) who can commit and adhere to intervention or control schedule, capable of providing informed consent, can speak and read English, have not performed breathwork before, and are in at least their second year of study.
Exclusion Criteria: participants who have a serious psychiatric condition such as schizophrenia or bipolar disorder or be taking illicit drugs.

An initial pre-intervention questionnaire will be administered at least 2-days prior to interventions commencing.
A) For the breathwork group, the subjects will individually watch a one-hour online teaching with a qualified breathwork instructor (Johannes Egberts). This will be a pre-recorded video to be distributed to the intervention participants. Subjects will be informed on the theory of correct breathing practices, a brief history of breathwork, “the why”, and given instructions on how to practice the Little A breathing method (5 seconds in, 5 seconds out, 2 second hold) for 10 minutes twice daily for 12-weeks. They will also be provided with a 10-minute pre-recorded audio track which the participants will listen to when they practice.
Intervention code [1] 330135 0
Prevention
Intervention code [2] 330136 0
Treatment: Other
Intervention code [3] 330137 0
Lifestyle
Comparator / control treatment
The control group will follow current University protocols regarding mental health, such as accessing the on and off campus resources recommended by the University. Well-being pathways include mental health services, university counsellors, and student well-being support programs, which will be available to control group participants.
Following the 12-week period, a secondary post-intervention questionnaire will be administered to participants to be completed. At the end of the post-intervention questionnaire, there will be a subjective open-ended question for the participants to complete.
Control group
Active

Outcomes
Primary outcome [1] 340117 0
Self-reported resilience
Timepoint [1] 340117 0
Baseline and 12 weeks post-commencement of intervention
Primary outcome [2] 340365 0
Psychological well-being
Timepoint [2] 340365 0
Baseline and 12 weeks post-commencement of intervention
Primary outcome [3] 340366 0
Depression
Timepoint [3] 340366 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [1] 444246 0
Primary - Anxiety
Timepoint [1] 444246 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [2] 444247 0
Primary - Stress
Timepoint [2] 444247 0
Baseline and 12 weeks post-commencement of intervention
Secondary outcome [3] 444248 0
Primary - Insomnia
Timepoint [3] 444248 0
Baseline and 12 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
Subjects (aged 18-99) who can commit and adhere to intervention or control schedule, capable of providing informed consent, can speak and read English, have not performed breathwork before, and are in at least their second year of study.
Subjects will be paramedicine students from a) Victoria University, b) Monash University, c) ACU, and d) La Trobe.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who have a serious psychiatric condition such as schizophrenia or bipolar disorder or be taking illicit drugs or have performed breathwork before.

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 involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software at a ratio of 1:1.
Matching between participants will ensue if required, so that gender and age are equally distributed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Using G*Power (latest ver. 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) software, this sample size was calculated with an effect size of 0.5, power of 0.8, significance of 0.05 and 2 groups. This equated to n=64 in each group, rounded to 80 for attrition, incomplete data, or dropouts. Informed consent will be obtained from all participating subjects with the ability to withdraw at any time.

Statistical analysis using mixed measures ANOVA will be used to efficiently assess between-subject (intervention types) and within-subject (repeated measures) effectiveness simultaneously. A mixed measures ANOVA has been chosen to determine effectiveness of the interventions while reducing the risk of Type I error (false positives). If a significant result is found, Tukey’s Honestly Significant Difference (HSD) post-hoc test will be used.
Significance will be accepted at p<0.05, and differences will be expressed as mean ±95% confidence limits and effect sizes.
Pearson Correlation analysis will be used to investigate the strength and direction of linear relationships between the continuous variables of age; DASS-21 scores; ISI; RS-14; and RPWB-18 post-intervention. Patterns between mental health variables will be identified following intervention.
Simple Linear Regression analysis will be used to explore which intervention or control can more greatly influence resilience and psychological well-being. Thus, providing insight into which intervention, if any, can contribute to positive and preventative mental health outcomes.
Leximancer Text Analytics Software (Version 5) will be used to analyse the qualitative data from the open-ended question.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2025
Actual
Date of last participant enrolment
Anticipated
10/03/2025
Actual
Date of last data collection
Anticipated
9/06/2025
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 318007 0
University
Name [1] 318007 0
Griffith University
Country [1] 318007 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320349 0
None
Name [1] 320349 0
None
Address [1] 320349 0
Country [1] 320349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316668 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316668 0
Ethics committee country [1] 316668 0
Australia
Date submitted for ethics approval [1] 316668 0
13/11/2024
Approval date [1] 316668 0
06/12/2024
Ethics approval number [1] 316668 0
GU2024/767

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

Contacts
Principal investigator
Name 138594 0
Ms Abbie Little
Address 138594 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138594 0
Australia
Phone 138594 0
+61417128159
Fax 138594 0
Email 138594 0
[email protected]
Contact person for public queries
Name 138595 0
Abbie Little
Address 138595 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138595 0
Australia
Phone 138595 0
+61417128159
Fax 138595 0
Email 138595 0
[email protected]
Contact person for scientific queries
Name 138596 0
Abbie Little
Address 138596 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138596 0
Australia
Phone 138596 0
+61417128159
Fax 138596 0
Email 138596 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The public upon request

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified raw data points for all measures to validate findings

What types of analyses could be done with individual participant data?
• Any

When can requests for individual participant data be made (start and end dates)?
From:
Upon publication around September 2025; no official end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Through the publishing journal.
Alternatively they can contact the lead researcher, Abbie Little, at [email protected].

Are there extra considerations when requesting access to individual participant data?
No


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.