Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001234404
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
1/10/2025
Date registered
Help: Date registered
6/11/2025
Date last updated
Help: Date last updated
6/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
6/11/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
Feasibility study looking at the impact of a structured breath work program on health and wellbeing of veterans
Scientific title
Feasibility study looking at the impact of Sudarshan Kriya Yoga program on health and wellbeing of veterans
Additional trial identifiers [1] 315251 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 338706 0
Post Traumatic Stress Disorder 338968 0
Well-being 338969 0
Suicide 338970 0
Condition category
Condition code
Mental Health 334992 334992 0 0
Depression
Mental Health 334993 334993 0 0
Suicide
Mental Health 334994 334994 0 0
Other mental health disorders
Mental Health 335046 335046 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will attend a structured five-day (3hrs/day) breath work program (face to face), based on the SKY (Sudarshan Kriya Yoga) breath work model by trained instructors from the International Association for Human Values (IAHV). Each day includes guided breathing techniques, group discussions, light physical stretching, and reflection. The breathing practices are designed to activate the parasympathetic nervous system, reduce physiological stress responses, and promote emotional regulation.

These sessions will be based in South-East Queensland at Griffith University and RSL locations.

Adherence will be monitored via surveys conducted at baseline, upon completion of day 5 and then at 1 month follow up.

Breakdown of the 3-hour sessions
Each daily session runs for approximately 2.5 to 3 hours and follows a consistent format that integrates theory, gentle movement, guided breathwork, meditation, and reflection. Typically, the first 45 to 60 minutes are devoted to a welcome or check-in, introductions, review of the previous session. These discussions often include group sharing and short interactive exercises. This is followed by around 15 to 20 minutes of light stretching or yoga, consisting of simple movements. The next 60 to 75 minutes focus on guided breathing practices. Participants are introduced to and practice a range of breathing techniques under the guidance of certified SKY instructors. The final 20 to 30 minutes are spent in guided meditation and reflection. Participants are led through relaxation and self-awareness exercises, followed by optional sharing or journaling to consolidate their experience.

Examples of breathing techniques used
Participants are progressively introduced to the core breathing techniques used in the Sudarshan Kriya Yoga (SKY) Resilience Program, SKY is a method of cyclical and rhythmic breathing practice aimed at promoting calmness that takes ~30 min per session. SKY practice consists of three distinct yogic breathing stages that use a range of slow, moderate, and fast breaths per minute. A SKY session is done in an upright seated posture, with closed eyes during practice. Including:

Alternative nostril breathing

Victory or Ocean Breath (Ujjayi) and Three-Stage Breathing: slow, rhythmic breathing patterns.

Bellows Breath (Bhastrika): short, energising breaths.

SKY Breath (short and long formats): a unique cyclic sequence of slow, medium, and fast rhythmic breathing.

Each technique is demonstrated and practiced under supervision, with rest periods between rounds and a guided meditation at the end.

Group discussions/sharing of experiences (This is voluntary)
The group discussions topics are structured around the daily themes, such as living in the present moment, sources of energy, self-awareness, emotional intelligence, and personal growth after service. Facilitators introduce each topic with a short presentation or prompt question (for example, “What are my goals?”).

Participants then engage in guided discussion, either as a full group (approximately 15 participants) or in smaller breakout groups of four to six participants. Sharing is entirely voluntary, and the facilitator ensures that the environment remains safe, supportive, and non-judgmental.

Examples of light physical stretching
Each session includes short periods of light physical stretching or yoga to prepare participants for breathing and meditation. These movements are gentle and low intensity, such as neck and shoulder rolls, standing side stretches, seated spinal twists, hip-opening stretches, and gentle balance postures .

Reflection component (This is voluntary)
Reflection takes place near the end of each session through guided meditation and self-reflection activities. Participants are invited to quietly consider questions such as their personal goals, challenges, lessons from the session, or areas of growth.
Intervention code [1] 331893 0
Treatment: Other
Intervention code [2] 332045 0
Behaviour
Description of the comparator or control
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342856 0
Feasibility
Timepoint [1] 342856 0
(i) eligibility rate assessed on day 1 of the study (after closure of the EOI survey) (ii) recruitment assessed on day 1 of the study (after closure of the EOI survey) (iii) protocol adherence assessed on day 5 of the study (iv) retention assessed 1 month after the program (after the closure of the 1 month follow up survey) (v) missing data assessed 1 month after the program (after the closure of the 1 month follow up survey) (vi) engagement assessed 1 month after the program (after the closure of the 1 month follow up survey) (vii) acceptability assessed 1 month after the program (after the closure of the 1 month follow up survey) (viii) safety assessed at baseline survey (day 1 of program) and 1 month after the program (after the closure of the 1 month follow up survey)
Secondary outcome [1] 451764 0
Wellbeing
Timepoint [1] 451764 0
Baseline, Day 5 of Program, 1-Month follow up
Secondary outcome [2] 452391 0
Depression
Timepoint [2] 452391 0
Baseline, Day 5 of Program, 1-Month follow up
Secondary outcome [3] 452392 0
PTSD
Timepoint [3] 452392 0
Baseline, Day 5 of Program, 1-Month follow up
Secondary outcome [4] 452397 0
Suicide
Timepoint [4] 452397 0
Baseline, Day 5 of Program, 1-Month follow up

Eligibility
Key inclusion criteria
Aged 18 years or older
Former ADF personnel
Not currently engaged in acute psychiatric treatment that would prevent participation in
group sessions (as assessed via self-report and referral advice, if applicable)
Not pregnant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Have significant cognitive impairments affecting informed consent or participation
Are currently undergoing a similar structured well-being program

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The composite primary objective for this study is to demonstrate the feasibility of conducting a powered trial to evaluate the intervention. The following feasibility parameters will be examined:

(i) eligibility (Greater than or equal to 75% of potential participants screened will meet inclusion criteria) - Assessed via REDCap EOI survey responses

(ii) recruitment (Greater than or equal to 70% of eligible participants consent to enrol into the study), Assessed via REDCap EOI survey responses

(iii) protocol adherence (greater than or equal to 80% of participants in intervention arm will adhere to the program), Assessed via session attendance over the five day course

(iv) retention (Greater than or equal to 85% of participants will complete all follow-up assessments) Assessed by the completion of the one-month survey on REDCap vs those who completed the 5 day course

(v) missing data (Less than or equal to 10% of data are missing), Assessed by the number of questions not answered vs the total number of questions provided over the three time points.

(vi) engagement (Greater than or equal to 70% of participants meet engagement criteria), Assessed via open ended question in follow-up survey, if the participants are practicing at home at least 5 times a week vs the people who completed the follow up survey

(vii) acceptability (Greater than or equal to 80% satisfaction in open-ended questions) Assessed via overall positive satisfaction in the course via the end of course survey

(viii) safety (Less than 5% severe adverse events or high-risk BSS alerts), Assessed at Baseline survey with a Becks Suicide Score or withdrawal from course due to serious adverse event less than 5%

Additionally: Quantitative data will be analysed using SPSS or Stata. Descriptive statistics will
summarise demographics and baseline characteristics. Pre–post and follow-up
comparisons will be conducted using paired t-tests or repeated-measures ANOVA (or
appropriate non-parametric alternatives). Open-ended feedback will be analysed
thematically to capture participant experiences and program suggestions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2025
Actual
Date of last participant enrolment
Anticipated
21/11/2025
Actual
Date of last data collection
Anticipated
25/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319817 0
Charities/Societies/Foundations
Name [1] 319817 0
RSL Queensland
Country [1] 319817 0
Australia
Funding source category [2] 319862 0
University
Name [2] 319862 0
Griffith University
Country [2] 319862 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 322388 0
Charities/Societies/Foundations
Name [1] 322388 0
RSL Queensland
Address [1] 322388 0
Country [1] 322388 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318377 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 318377 0
Ethics committee country [1] 318377 0
Australia
Date submitted for ethics approval [1] 318377 0
12/06/2025
Approval date [1] 318377 0
Ethics approval number [1] 318377 0
Ethics committee name [2] 318416 0
Department of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [2] 318416 0
Ethics committee country [2] 318416 0
Australia
Date submitted for ethics approval [2] 318416 0
30/06/2025
Approval date [2] 318416 0
22/09/2025
Ethics approval number [2] 318416 0
656-25

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

Contacts
Principal investigator
Name 143990 0
Dr Gayatri Marwah
Address 143990 0
Ian O'Connor Building (G40) Level 8, Griffith University, Parklands Drive Southport Qld 4222.
Country 143990 0
Australia
Phone 143990 0
+61 7 5678 0439
Fax 143990 0
Email 143990 0
[email protected]
Contact person for public queries
Name 143991 0
Zane Zulli
Address 143991 0
Ian O'Connor Building (G40) Level 8, Griffith University, Parklands Drive Southport Qld 4222.
Country 143991 0
Australia
Phone 143991 0
+61756780346
Fax 143991 0
Email 143991 0
[email protected]
Contact person for scientific queries
Name 143992 0
Gayatri Marwah
Address 143992 0
Ian O'Connor Building (G40) Level 8, Griffith University, Parklands Drive Southport Qld 4222.
Country 143992 0
Australia
Phone 143992 0
+61 7 5678 0439
Fax 143992 0
Email 143992 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Sharing participant data in a public forum is not included in the ethics approval.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    4. EV_Participant-Information-Sheet-online-surveys 1 (1).pdf


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.