Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000346673
Ethics application status
Approved
Date submitted
21/03/2023
Date registered
3/04/2023
Date last updated
11/07/2024
Date data sharing statement initially provided
3/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-delivery of tele trial Behavioural Activation in people in custody with depression: a feasibility Randomised Controlled Trial
Scientific title
Investigating the feasibility of a Tele trial Behavioural Activation program for people in custody with mild to moderate depression
Secondary ID [1] 309252 0
Nil
Universal Trial Number (UTN)
Trial acronym
TBCD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 329408 0
Condition category
Condition code
Mental Health 326354 326354 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A sample of 60 people in custody aged over 18 years or older with presenting symptoms of depression as assessed using the PHQ 9 scale (with a score of 5-14 mild to moderate depression) will participate in the trial. Recruited people in custody will be randomised to receive Behavioural Activation (BA) plus treatment as usual (TAU) or TAU for depression provided by custodial health nurses. Eight custodial health nurses will be recruited from four rural prisons in South Australia.

The BA intervention will involve custodial nurses preparing people in custody to monitor their mood, identify triggers that can impact mood, identify activities that may enhance mood, and enable each participating person in custody to formulate an activity schedule. Next the custodial nurses will provide participants six 1-1 BA conversations with people in custody once a week for six weeks. The custodial nurses will be supervised by experts in BA via a tele health format. Each conversation will last up to 30minutes in duration.

The custodial health nurses that join the study will be trained to deliver BA. The training on BA techniques will be based on an academically accredited and established online “Professional Certificate in BA for Depression” program offered by the University of South Australia. The 10-week online training program consists of five modules: (a) the evidence base of BA (b) introduction to BA (c) assessment and mood monitoring (d) functional analysis, and (e) activity scheduling.
Intervention code [1] 325688 0
Behaviour
Comparator / control treatment
People in custody allocated to the control group will receive the usual prison health care alone. No other specific intervention will be provided to this group. Across sites, TAU will be composed of 30 participants.

Control group
Active

Outcomes
Primary outcome [1] 334205 0
Primary Health Questionnaire Nine (PHQ 9).

Depressive symptoms will be measured with the Primary Health Questionnaire Nine (PHQ 9).
Timepoint [1] 334205 0
The primary outcome measure will be implemented at three-time points
Baseline (0 weeks),
6 weeks post-intervention (primary timepoint),
3 months post-intervention.
Secondary outcome [1] 419834 0
The secondary outcome will be the level of health-related quality of life as measured by the 36-Item Short Form Health Survey (SF 36). The SF 36 measures physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotion, and mental health .
Timepoint [1] 419834 0
In this study, we will administer the SF 36 questionnaire at three-time points:
Baseline (0 weeks),
Immediately after postintervention (6 weeks),
At three months post-intervention.

Eligibility
Key inclusion criteria
The study will comprise two groups of participants: Custodial health nurses and people in custody with depressive symptoms.
(a) Custodial health nurses
Custodial health nurses employed by CALHN who complete training in BA and agree to participate in the study.
(b) People in custody that are:
(i) Aged 18 years or above.
(ii) Receiving a primary health care service by SA health nurses provided by CALHN at any of the four participating prison sites.
(iii) Experiencing mild to moderate depressive symptoms as demonstrated with a baseline score of 5-14 (mild to moderate depression) (18) on the PHQ-9 scale.
(iv) Understand, read, write, and speak English.
(v) Provide informed consent.
Prior or current use of medication or psychotherapy will not be a precluding factor.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(a) Custodial health nurses
Custodial health nurses employed by CALHN who have not completed training in BA
Custodial health nurses employed by CALHN who are planning to leave the service within the next twelve months.
(b) People in custody
We will exclude people in custody who:
(i) Have depressive symptoms and achieve a baseline score of 15+ on the PHQ-9 scale or acute depression. These people will be excluded from the study for their safety.
(ii) Express suicidal ideation or are at risk of self-harm, suicide, homicide, or present a risk to others. These potential participants will be referred to a general practitioner or mental health professional for support.
(iii) Have multiple mental health diagnoses.
(iv) Have a Department for Corrections (DCS) Notice of Concern (NOC) and are placed for High-Risk Assessment Team (HRAT) review. (v) Are actively being treated by Mental Health or Forensic Mental Health team.
(vi) Have a disorder that impedes effective communication (eg, severe sensory impairment) or experience difficulty communicating effectively in English.
(vii) Are unable to provide informed consent to participate in the study.


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)
An external computerised randomisation service will be contracted to generate random allocation once relevant baseline data has been collected. . Following baseline data collection from consenting people in custody, the tele-trial trial nurse will insert the unique participant ID into Sealed Envelope (sealedenvelope.com), an online software application for randomising patients into clinical trials. The online computer application will generate treatment allocation and send an email confirmation of the group allocation to the tele-trial research nurse. The allocation sequence is retained by the contracted service and the tele-trial research nurse will be unaware of group allocation until receiving confirmation for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with random permuted block sizes will ensure appropriate treatment allocation concealment and equal sample sizes across the three groups.
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
Safety/efficacy
Statistical methods / analysis
Our target sample size is 60 people in custody and eight custodial health nurses. We determined our sample size estimation based on the median sample size per arm of 30 recommended for feasibility studies with continuous outcome measures such as levels of depressive symptoms.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/11/2023
Actual
9/11/2023
Date of last participant enrolment
Anticipated
10/02/2025
Actual
Date of last data collection
Anticipated
19/05/2025
Actual
Sample size
Target
68
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313442 0
University
Name [1] 313442 0
University of South Australia
Country [1] 313442 0
Australia
Primary sponsor type
Government body
Name
SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
Address
SA/NT Regional Clinical Trial Coordinating Centre (SA/NT RCCC)
Office for Research
Department for Health and Wellbeing
Clinical Collaboration
System Leadership and Design
Level 5,
Citi Centre Building
11 Hindmarsh Square
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 315217 0
None
Name [1] 315217 0
Address [1] 315217 0
Country [1] 315217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312648 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 312648 0
Ethics committee country [1] 312648 0
Australia
Date submitted for ethics approval [1] 312648 0
04/08/2023
Approval date [1] 312648 0
04/08/2023
Ethics approval number [1] 312648 0
Ethics committee name [2] 315686 0
Central Adelaide Local Health Network HREC
Ethics committee address [2] 315686 0
Ethics committee country [2] 315686 0
Australia
Date submitted for ethics approval [2] 315686 0
02/06/2023
Approval date [2] 315686 0
28/06/2023
Ethics approval number [2] 315686 0
2023/HRE00097
Ethics committee name [3] 315687 0
Department for Correctional Services
Ethics committee address [3] 315687 0
Ethics committee country [3] 315687 0
Australia
Date submitted for ethics approval [3] 315687 0
20/10/2023
Approval date [3] 315687 0
23/10/2023
Ethics approval number [3] 315687 0
N/A

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

Contacts
Principal investigator
Name 125418 0
A/Prof Martin Jones
Address 125418 0
University of South Australia
57 Wellington Street
Mount Barker
SA 5251
South Australia
Country 125418 0
Australia
Phone 125418 0
+61 0401198633
Fax 125418 0
Email 125418 0
martin.jones@unisa.edu.au
Contact person for public queries
Name 125419 0
Martin Jones
Address 125419 0
University of South Australia
57 Wellington Street
Mount Barker
SA 5251
South Australia
Country 125419 0
Australia
Phone 125419 0
+61 0401198633
Fax 125419 0
Email 125419 0
martin.jones@unisa.edu.au
Contact person for scientific queries
Name 125420 0
Sandra Walsh
Address 125420 0
Department of Rural Health, University of South Australia, 111 Nicolson Avenue, Whyalla Campus, Whyalla Norrie, SA 5608
Country 125420 0
Australia
Phone 125420 0
+61 439328641
Fax 125420 0
Email 125420 0
sandra.walsh@unisa.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?
De-identified person in “custody data” and deidentified location data that will be generated by this study will be made available upon written request, to enable trial checking and reuse.
When will data be available (start and end dates)?
This will be made available once the findings have been published with no end date.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator Martin Jones, martin.jones@unisa.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18641Study protocol    The study protocol will be a protocol publication.
18642Statistical analysis plan    The statistical analysis/data analysis plan will a... [More Details]
18643Ethical approval    A copy of our ethics application will be made avai... [More Details]



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.