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Trial registered on ANZCTR


Registration number
ACTRN12624000501549p
Ethics application status
Submitted, not yet approved
Date submitted
19/03/2024
Date registered
23/04/2024
Date last updated
23/04/2024
Date data sharing statement initially provided
23/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Is it possible to conduct a trial of a talking treatment for depression in farmers with mood problems.
Scientific title
Back-on-Track: Randomised controlled feasibility trial of behavioural activation in farmers with mild-to-moderate depression
Secondary ID [1] 311773 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BoT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate depression 333279 0
Condition category
Condition code
Mental Health 329972 329972 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Back-on-Track is an individual ten-session (that will last around 30 minutes, delivered approximately weekly, either face-to face or using video conferencing) psychological intervention based on Behavioural Activation. Back-on-Track encourages a person to develop or get back into activities which are meaningful to them by scheduling activities and monitoring behaviours and looking at specific situations where changing these behaviours and activities may be helpful (activity scheduling and mood monitoring). People will be asked to complete worksheets (that will be developed for the purposes of the study) during and after the session (worksheets will take no more than 20 minutes to complete each week and involve making a plan for the week and rating mood on a daily basis). Peer workers will be encouraged to, generally, adhere to the structure of the Back-on-Track approach but can tailor sessions to address individual contexts.

Peer workers will complete the Back-on-Track training package that includes:
1. Introduction to Back-on-Track
2. Behavioural activation training – University of South Australia Professional Certificate in Behavioural Activation for Depression.
3. Peer worker fortnightly clinical supervision.
In total the Back-on-Track training package will take 76 hours to complete. Trainee peer workers will need to pass a standardised competency assessment to successfully complete the program to become a Back-on-Track peer worker.
The training lead for the trial is Associate Professor Martin Jones, other members of the research team will also contribute to the training as required.
Intervention code [1] 328223 0
Behaviour
Comparator / control treatment
Participants allocated to the control intervention will receive treatment as usual and will be sent the Managing Stress on the Farm self-help workbook. This booklet provides information, practical activities and links to further resources to support the mental health of farmers, farm workers, farming families and the broader farming community. Participants are asked to spend 1 hour per week using the workbook for 10 weeks
Control group
Active

Outcomes
Primary outcome [1] 337729 0
Feasibility outcomes - peer workers
o Recruitment of ten peer workers.
o Eight trainee peer workers successfully complete the Back-on-Track training package.
o Six peer workers are employed as peer workers to deliver the Back-on-Track intervention.
o Five peer workers are retained at the completion of the project.
Timepoint [1] 337729 0
End of the trial.
Primary outcome [2] 337961 0
Feasibility outcomes for members of the farming community with mild to moderate depression:
o One-hundred and twenty members of the farming community express an interest in taking part in the trial.
o Forty consent to participate in the trial.
o Forty complete baseline measures.
o Forty agree to be randomised.
o Forty commence the Back-on-Track program.
o Thirty-two complete the Back-on-Track program (defined as attending six of the ten sessions. The minimum duration of a session is ten minutes).
o Thirty-two complete week 10 (after baseline assessment) measures.
o Twenty-eight complete week 26 (after baseline assessment) measures.
Timepoint [2] 337961 0
End of the trial
Primary outcome [3] 337962 0
Feasibility outcome - Ninety per-cent of the Behavioural Activation (BA) sessions are delivered to at least a satisfactory level of fidelity to model
Timepoint [3] 337962 0
A random 10% sample of sessions conducted during the trial will be audio recorded, and blind rated using the behavioural activation fidelity, by an independent (not part of the research group) researcher experienced in behavioural activation.
Secondary outcome [1] 433018 0
Work productivity
Timepoint [1] 433018 0
Baseline (week 0), week 10 and week 26 post-baseline.
Secondary outcome [2] 433019 0
Loneliness
Timepoint [2] 433019 0
Baseline (week 0), week 10 and week 26 post-baseline.
Secondary outcome [3] 433020 0
Wellbeing
Timepoint [3] 433020 0
Baseline (week 0), week 10 and week 26 post-baseline.
Secondary outcome [4] 433887 0
Depression
Timepoint [4] 433887 0
Baseline (week 0), week 10 and week 26 post-baseline.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. PHQ-9 (Patient Health Questionnaire) score of between 5 and 19 (indicative of mild to moderate depression).
2. Self identifies as a member of the farming community
3. Not currently receiving any formal psychological treatment (e.g., Cognitive Behavioural Therapy) for any mental health problem.
4. Does not have serious long term health conditions that may necessitate hospital admission or regular contact with secondary health services during the trial
5. Are not actively suicidal or have attempted suicide in the past two months
6. Does not have a diagnosis of psychosis, personality disorder, or cognitive impairment
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be undertaken using a web-based randomisation service (sealedenvelope.com)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using a web-based randomisation service (sealedenvelope.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will use descriptive statistics (predominantly number and proportion) to summarise the feasibility outcomes from our trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316105 0
Charities/Societies/Foundations
Name [1] 316105 0
Gardiner Foundation
Country [1] 316105 0
Australia
Primary sponsor type
Hospital
Name
Western District Health Service
Address
Country
Australia
Secondary sponsor category [1] 318273 0
None
Name [1] 318273 0
Address [1] 318273 0
Country [1] 318273 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314932 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 314932 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 314932 0
Australia
Date submitted for ethics approval [1] 314932 0
19/03/2024
Approval date [1] 314932 0
Ethics approval number [1] 314932 0

Summary
Brief summary
We are undertaking a randomised controlled trial to test if it is feasible to conduct a full scale study of the safety and effectiveness of peer worker (people with lived experience of living and working in the farming community) delivered behavioural activation (a brief evidence based psychological treatment for depression) for people with moderate to severe depression. We want to find out if it is possible to recruit and train peer workers, if they can sucessfully deliver the intervention and if people from farming communities will agree to participate in a clinical trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133178 0
A/Prof Alison Kennedy
Address 133178 0
Western District Health Service, PO Box 283, MacKellar House Tyers street, Hamilton, Victoria 3300 Australia
Country 133178 0
Australia
Phone 133178 0
+61 407549970
Fax 133178 0
Email 133178 0
a.kennedy@deakin.edu.au
Contact person for public queries
Name 133179 0
Alison Kennedy
Address 133179 0
Western District Health Service, PO Box 283, MacKellar House Tyers street, Hamilton, Victoria 3300 Australia
Country 133179 0
Australia
Phone 133179 0
+61 407549970
Fax 133179 0
Email 133179 0
a.kennedy@deakin.edu.au
Contact person for scientific queries
Name 133180 0
Richard Gray
Address 133180 0
School of Nursing and Midwfery, La Trobe University Plenty Rd, Bundoora Victoria 3086
Country 133180 0
Australia
Phone 133180 0
+61 481248182
Fax 133180 0
Email 133180 0
r.gray@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Complete data set (deidentified)
When will data be available (start and end dates)?
From December 2025, indefinitely
Available to whom?
Anyone
Available for what types of analyses?
Any
How or where can data be obtained?
IPD can be obtained by contacting the Chief Investigator (Dr Alison Kennedy, Western District Health Service, PO Box 283, MacKellar House Tyers street, Hamilton, Victoria 3300, Australia. E: a.kennedy@deakin.edu.au)

The data set will be made available via the Deakin University data repository.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21894Study protocol    387530-(Uploaded-19-03-2024-14-25-31)-Study-related document.pdf



Results publications and other study-related documents

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