Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001633178
Ethics application status
Approved
Date submitted
7/11/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The boxing group trial: An evaluation of an existing clinical intervention (a boxing group) for young people with severe mental health disorders
Scientific title
The boxing group trial: An evaluation of an existing clinical intervention (a boxing group) for young people with severe mental health disorders
Secondary ID [1] 299721 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First episode psychosis 315064 0
bipoloar-disorder 315065 0
major depressive disorder 315066 0
borderline personality disorder 315067 0
Condition category
Condition code
Mental Health 313399 313399 0 0
Psychosis and personality disorders
Mental Health 313400 313400 0 0
Schizophrenia
Mental Health 313401 313401 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The boxing group has already been established at Orygen and is run once per week by 2 qualified instructors. This study aims to evaluate this intervention. In addition to the standard case-management and medical management offered at Orygen, participants consenting to take part in the study will be invited to attend a 6-week boxing group run once a week at Orygen.

The group is run once a week and lasts one hour and is run by a fully qualified boxing coach who is also a clinical psychologist. It is supported by an exercise physiologist. Both are trained in First Aid, with a defibrillator and first aid box being available in the gym where the boxing group will occur.

The class consists of warming up, followed by learning/practicing a combination of boxing moves in pairs (for example using jabs, crosses, uppercuts, hooks, slips, weaves or covers where 1 participant hits focus mitts while the other holds), then a strength & conditioning exercise – typically a large muscle group e.g. lunges or jump squats for legs. This format is repeated three times, followed by a warm down and static stretch. To end with, the coach leads a debrief with the group discussing the following: 1) What part of the session they enjoyed the most, 2) What their partner did well, 3) What health/ fitness goals they will work on during the week.

Adherence to the intervention will monitored though session attendance checklist, i.e. how many of the 6 sessions offered were attended by the participant
Intervention code [1] 315984 0
Lifestyle
Intervention code [2] 316170 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321900 0
To determine the feasibility and acceptability of a weekly boxing group run for young people with severe mental health disorders. This will include:
- Establish the number of young people that will consent to participate in a trial of a boxing group using the recruitment log.
- Establish the proportion of participants that attend 6 session of the boxing group, using the attendance log..
- Determine the acceptability of the proposed outcome measures through completion rates and qualitative interviews. (Participants will be invited to take part in a one-to-one interview or a focus group with other intervention group members after they have completed the six group sessions they are offered as part of the intervention. The interview/focus group will last between 30 and 45 minutes and be undertaken by one of the research team following a semi-structred interview guide).
- Establish the proportion of participants that complete the trial, through recruitment and attendance log.
Timepoint [1] 321900 0
Baseline, 6 weeks.
Secondary outcome [1] 376628 0
To determine whether attending a weekly boxing group improved the physical strength of young people with severe mental health disorders measured using the strength max push-up test
Timepoint [1] 376628 0
Baseline, 6 weeks.
Secondary outcome [2] 376629 0
To determine whether attending a weekly boxing group improved the mental well-being of young people with severe mental health disorders measured using the DASS-21.
Timepoint [2] 376629 0
Baseline, 6 weeks.
Secondary outcome [3] 376630 0
To determine whether attending a weekly boxing group improved the schemas held by young people with severe mental health disorders, as determined using Young Schema Questionnaire.
Timepoint [3] 376630 0
Baseline, 6 weeks.
Secondary outcome [4] 376631 0
To investigate how young people experienced the boxing group using thematic analysis of qualitative interviews. Participants will be invited to take part in a one-to-one interview or a focus group with other intervention group members after they have completed the six group sessions they are offered as part of the intervention. The interview/focus group will last between 30 and 45 minutes and be undertaken by one of the research team following a semi-structured interview guide.
Timepoint [4] 376631 0
The qualitative interviews will occur between the end of the 6th intervention session offered and 4 weeks after the 6th session offered.
Secondary outcome [5] 376970 0
To determine whether attending a weekly boxing group improved the physical strength of young people with severe mental health disorders measured using the 60 second sit-to-stand test
Timepoint [5] 376970 0
Baseline, 6 weeks.
Secondary outcome [6] 376971 0
To determine whether attending a weekly boxing group improved the mental well-being of young people with severe mental health disorders measured using the BPRS
Timepoint [6] 376971 0
Baseline, 6 weeks.
Secondary outcome [7] 376972 0
To determine whether attending a weekly boxing group improved the mental well-being of young people with severe mental health disorders measured using the UCLA loneliness scale.
Timepoint [7] 376972 0
Baseline, 6 weeks.

Eligibility
Key inclusion criteria
a) Eligible for OYH services which involves: residing within the geographically defined catchment area, be aged between 15 and 25 and one of the following:
- for EPPIC: experiencing a first episode of psychosis (defined as experiencing at least one positive psychotic symptom on a daily basis for at least one week)
- for PACE: might be at risk of developing psychosis i.e. attenuated positive psychotic symptoms at subthreshold symptom intensity or frequency, present within the last year for at least a week, or brief limited intermittent psychotic symptoms, which are full-threshold psychotic symptoms that have lasted no more than 1 week and remitted without intervention, or trait vulnerability, defined as either schizotypal personality disorder in that individual, or a first-degree relative with a psychotic disorder diagnosis.
- for HYPE: meeting 3 out of the 9 DSM-5 criteria of borderline personality disorder
- for the Mood clinic: experiencing depression, bipolar II disorder (non-psychotic bipolar disorder) and severe anxiety disorders such as anxiety and obsessive compulsive disorder.

b) Ability to provide informed consent.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) An inability to provide informed consent.
b) Physical activity is contra-indicated, as assessed by the person’s GP or treating doctor.

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
Efficacy
Statistical methods / analysis
QUANTITATIVE DATA
Clinical and demographic data will be presented using descriptive statistics. Differences between pre and post measures will be analysed using within sample t-tests in order to inform future sample size calculations.

QUALITATIVE DATA
Data gathered from focus groups and interviews will be transcribed verbatim and subsequently analysed using thematic analysis. Again, where possible, a young person with lived experience will collaborated with the research team to analyse the results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2020
Actual
Date of last participant enrolment
Anticipated
15/03/2021
Actual
Date of last data collection
Anticipated
26/04/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15115 0
Orygen Youth Health - Parkville - Parkville
Recruitment hospital [2] 15116 0
Orygen Youth Health - Sunshine - Sunshine
Recruitment postcode(s) [1] 28409 0
3052 - Parkville
Recruitment postcode(s) [2] 28410 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 304191 0
University
Name [1] 304191 0
University of Melbourne
Country [1] 304191 0
Australia
Primary sponsor type
Other
Name
Orygen
Address
35 Poplar road, Parkville, Victoria, 3052
Country
Australia
Secondary sponsor category [1] 304447 0
None
Name [1] 304447 0
Address [1] 304447 0
Country [1] 304447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304661 0
Melbourne Health HREC
Ethics committee address [1] 304661 0
Ethics committee country [1] 304661 0
Australia
Date submitted for ethics approval [1] 304661 0
Approval date [1] 304661 0
03/10/2019
Ethics approval number [1] 304661 0

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

Contacts
Principal investigator
Name 97762 0
Dr Ellie Brown
Address 97762 0
Orygen, 35 Poplar road, Parkville, Victoria, 3052
Country 97762 0
Australia
Phone 97762 0
+61 487 786 465
Fax 97762 0
Email 97762 0
[email protected]
Contact person for public queries
Name 97763 0
Ellie Brown
Address 97763 0
Orygen, 35 Poplar road, Parkville, Victoria 3052
Country 97763 0
Australia
Phone 97763 0
+61 487 786 465
Fax 97763 0
Email 97763 0
[email protected]
Contact person for scientific queries
Name 97764 0
Ellie Brown
Address 97764 0
Orygen, 35 Poplar road, Parkville, Victoria 3052
Country 97764 0
Australia
Phone 97764 0
+61 487 786 465
Fax 97764 0
Email 97764 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
Due to lack of funding to support a research assistant to manage these enquiries


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.