Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000714482
Ethics application status
Approved
Date submitted
23/06/2025
Date registered
7/07/2025
Date last updated
7/07/2025
Date data sharing statement initially provided
7/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Trauma and violence-informed cardio-boxing for female victim-survivors of intimate partner violence
Scientific title
Acceptability and feasibility of a trauma and violence-informed cardio-boxing for female victim-survivors of intimate partner violence
Secondary ID [1] 314637 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post traumatic stress disorder 337788 0
Psychological distress 337790 0
Mental health and wellbeing 337791 0
Condition category
Condition code
Mental Health 334132 334132 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 334322 334322 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mixed methods approach utilising stepped-wedge design to gather data related to the acceptability, feasibility and preliminary effectiveness of an eight-week trauma and violence-informed (TVI), non-contact cardio-boxing intervention for women who have experienced intimate partner violence.

Intervention:
This in-person (group-based) TVI non-contact cardio-boxing program is multicomponent in design and will include elements of:
• a mental health check-in at the start of each session
• aerobic warm-up
• teaching of cardio-boxing skills (safety and form)
• moderate-vigorous non-contact cardio-boxing drills
• psychoeducation around managing trauma symptoms, emotional regulation strategies
• mindful cool-down / containment exercises
Sessions will be conducted on a weekly basis for 8-weeks and the curriculum will be progressive in terms of skill development degree of difficulty. Each session will run for 90 minutes and comprise 60 minutes of physical activity with 30 minutes set aside for psycho-education and containment exercises / activities.

Four groups of eight women per group will be exposed to the same intervention on a weekly basis for the duration of the intervention. Prior to the start of the intervention, each group will be randomly assigned to a different baseline (T -5 weeks - T -2 weeks) where women will be asked to complete the Kessler K6 to measure psychological distress each week throughout the baseline period and fortnightly throughout the intervention. The intervention will be run at an established TVI gender-sensitive martial arts gym.

Groups will be co-facilitated by a TVI boxing instructor and a mental health clinician to support participant safety. The boxing instructor has a Bachelors in Exercise Science, 15+ years experience as martial artist including traditional boxing and black belt in Muay Thai, including a number of professional fights. She is the founder of a TVI, gender-sensitive mixed martial arts charitable organisation for women who have experienced gendered violence. The mental health clinician is an accredited and practicing Clinical Counsellor and Psychotherapist with a special interest on supporting women who have experienced a range of traumatic experiences, including but not limited to gender-based violence (GBV) and childhood sexual abuse using bottom-up trauma and violence-informed approaches. She has over 10 years experience in the field.

To assess feasibility of the intervention recruitment and consent rates will be measured. In addition, feasibility will be assessed based on participant retention through the trial, measured in two ways (all de-identified):
1. the number of participants who remained in the group until program completion
2. the number of participants who completed all the post-intervention assessments / follow-ups

Attendance records will be kept via a spreadsheet and will record participant / session / group across the eight-week duration to measure adherence to the program, including those participants who attend the PA component only, and those who attend the PA component and the additional psychoeducation / mindfulness component.
Intervention code [1] 331262 0
Treatment: Other
Intervention code [2] 331263 0
Lifestyle
Intervention code [3] 331264 0
Behaviour
Comparator / control treatment
Stepped-wedge trial design allowing all participants to experience the intervention without need for control group. Each group will be randomly assigned to a different baseline lengths and data will be collected on multiple occasions prior to the intervention through the baseline period to detect whether the intervention has an effectivity significantly greater than the underlying secular trend. In this way participants act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 341842 0
Acceptability
Timepoint [1] 341842 0
Post completion of intervention program: 1 week and 4 weeks
Primary outcome [2] 341843 0
Feasibility - this will be assessed as a composite outcome
Timepoint [2] 341843 0
Pre-intervention (audit of recruitment records) Baseline, weeks 1 - 8 of intervention, post completion of intervention program: 1 week and 4 weeks
Secondary outcome [1] 448816 0
Psychological distress
Timepoint [1] 448816 0
Each week of baseline (will be different for each group) - up to -5 weeks, baseline, weeks 2, 4, 6, 8 of intervention and post completion of intervention program: 1 week and 4 weeks.
Secondary outcome [2] 448817 0
PTSD symptoms
Timepoint [2] 448817 0
Baseline and post completion of intervention program: 1 week and 4 weeks.
Secondary outcome [3] 448818 0
Interoceptive Awareness
Timepoint [3] 448818 0
Baseline and post completion of intervention program: 1 week and 4 weeks.
Secondary outcome [4] 448819 0
Resilience
Timepoint [4] 448819 0
Baseline and post completion of intervention program: 1 week and 4 weeks.
Secondary outcome [5] 448820 0
Quality of Life
Timepoint [5] 448820 0
Baseline and post completion of intervention program: 1 week and 4 weeks.
Secondary outcome [6] 448821 0
Sleep quality
Timepoint [6] 448821 0
Baseline and post completion of intervention program: 1 week and 4 weeks.
Secondary outcome [7] 448822 0
Participation in leisure-time physical activity
Timepoint [7] 448822 0
Baseline and post completion of intervention program: 1 week and 4 weeks.
Secondary outcome [8] 448825 0
Implementation and dissemination strategies
Timepoint [8] 448825 0
Post completion of intervention program: 4 weeks.

Eligibility
Key inclusion criteria
Self-identified women or people who have ‘female’ recorded on their original birth certificate who:
1) have a lived / living experience of self-identified intimate partner violence (IPV)
2) are self-determined as physically safe / removed from threat of IPV
3) are aged 18-years+
4) reside in metro Melbourne and can travel to Abbotsford (VIC) by car / public transport
5) can communicate fluently in English

For the purposes of this study, IPV might include aspects of any / all the following forms of violence: psychological, emotional, sexual, physical, financial, coercive control within the context of an intimate partner relationship. This does not have to include cohabiting relationships and might be within the context of a dating / short-term relationship. In line with TVI principles, and informed by other research in the field, the research team will not be utilising any formal process to confirm these experiences and will be led by participants self-identifying as victim-survivors of IPV.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be excluded from the study based on the following criteria:
1) pregnant
2) presence of contradiction to moderate vigorous physical activity (MVPA) (e.g., significant cardiovascular, metabolic, musculoskeletal, or neurological disease) per Exercise and Sports Science Australia (ESSA) Pre-Exercise Screening Tool
3) unable to communicate in English
4) have worked with the PhD student / SI within her professional capacity as a Clinical Counsellor & Psychotherapist (will be included as part of the screening process)
5) Unable or unwilling to attend the venue at Conscious Combat Club (Abbotsford, VIC) for the duration of the intervention

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319198 0
University
Name [1] 319198 0
Deakin University
Country [1] 319198 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 321710 0
None
Name [1] 321710 0
Address [1] 321710 0
Country [1] 321710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317780 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 317780 0
Ethics committee country [1] 317780 0
Australia
Date submitted for ethics approval [1] 317780 0
26/02/2025
Approval date [1] 317780 0
03/06/2025
Ethics approval number [1] 317780 0
2025/HE000153

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

Contacts
Principal investigator
Name 142126 0
A/Prof Megan Teychenne
Address 142126 0
Institute for Physical Activity & Nutrition, Deakin University, 221 Burwood Hwy, Burwood, VIC, 3125
Country 142126 0
Australia
Phone 142126 0
+61 3 9244 6910
Fax 142126 0
Email 142126 0
[email protected]
Contact person for public queries
Name 142127 0
Thea Baker
Address 142127 0
Institute for Physical Activity & Nutrition, Deakin University, 221 Burwood Hwy, Burwood, VIC, 3125
Country 142127 0
Australia
Phone 142127 0
+61 3 9244 6613
Fax 142127 0
Email 142127 0
[email protected]
Contact person for scientific queries
Name 142128 0
Thea Baker
Address 142128 0
Institute for Physical Activity & Nutrition, Deakin University, 221 Burwood Hwy, Burwood, VIC, 3125
Country 142128 0
Australia
Phone 142128 0
+61 3 9244 6613
Fax 142128 0
Email 142128 0
[email protected]

Data sharing statement
Will the study consider sharing 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.