Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001017415
Ethics application status
Approved
Date submitted
4/08/2025
Date registered
12/09/2025
Date last updated
12/09/2025
Date data sharing statement initially provided
12/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Piloting implementation strategies to support deprescribing benzodiazepines in primary care practitioners
Scientific title
Deprescribing benzodiazepines: Examining the feasibility of strategies to support General Practitioners (GPs) through the deprescribing process
Secondary ID [1] 315040 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benzodiazepine dependence 338770 0
Condition category
Condition code
Public Health 334694 334694 0 0
Health service research
Mental Health 335064 335064 0 0
Anxiety
Mental Health 335065 335065 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Co-design process
A deprescribing conversation tool was co-designed by consumers with lived experience, general practitioners (GPs), and a GP advisory group. Consumers contributed via 60-minute focus groups, leading to a draft tool that was refined through an advisory group meeting and individual GP interviews (n = 13).
The resulting toolkit—also co-designed with GPs—includes the conversation tool, a tapering protocol, decision aid, patient resources, and access to free counselling and deprescribing support services (available in both digital and print formats). For the toolkit co-design, GPs participated in a Delphi study to identify the most useful support strategies, which were further refined through a one-hour advisory group meeting and 45-minute individual interviews with GPs (n = 7).
Toolkit components – brief descriptions
Conversation tool – 1 page co-designed document guiding GP through stages of readiness, main practice points and key questions. The flipside of this resource contains information on why deprescribing is important (statistics on side effects), preparation information, reduction rates and the monitoring process.
Tapering protocol and decision aid – based on the Maudsley deprescribing guidelines (Horowitz M, Taylor DM. The Maudsley Deprescribing Guidelines: Antidepressants, Benzodiazepines, Gabapentinoids and Z-drugs. New York: Wiley-Blackwell; 2024.)
Patient resources – existing patient resources on the topic (Deprescribing.org & National Institute for Health and Care Excellence resources).
List of available (free) counselling / deprescribing support – This is a list of freely available support services by state collated by the research team.

Toolkit implementation
GPs will be given access to the conversation tool resource via email & hard copies. These will contain a QR code that will link to a hosted website containing the remaining resources (tapering protocol & decision aid, patient resources, access to free counselling and deprescribing support services).
In addition, GPs will have access to a 1-hour workshop, co-delivered by a psychologist/Benzodiazepine deprescribing counsellor from an Alcohol and other drug (AOD) treatment service in Victoria (Reconnexion) and general practitioner. The workshop will involve practical deprescribing strategies. Participating GPs will be eligible for Continuing Professional Development (CPD) points for workshop attendance and monitoring.
The implementation pilot will have a 6-month duration, with toolkit resources delivered throughout, and the workshop at one time point. Depending on need there might be multiple workshops, but each GP will have access to 1 live workshop.
Adherence to the strategies will be assessed through survey and interview responses at 3 months and 6 months.
Intervention code [1] 331640 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342358 0
Primary outcome 1 – skills, confidence and willingness to identify and treat BZRA dependence (composite outcome)
Timepoint [1] 342358 0
Baseline, 3 months and 6 months post intervention commencement
Primary outcome [2] 342359 0
Primary outcome 2 – Uptake of resources and factors that influence uptake (composite)
Timepoint [2] 342359 0
3 months and 6 months post intervention commencement
Primary outcome [3] 342360 0
Primary outcome 3 –feasibility, acceptability, appropriateness of co-designed implementation strategies (composite)
Timepoint [3] 342360 0
6 months (end of intervention)
Secondary outcome [1] 450496 0
Knowledge on deprescribing BZRA dependence (exploratory)
Timepoint [1] 450496 0
Survey - Baseline, 3 months and 6 months post intervention commencement Interview - 3 months and 6 months post intervention commencement

Eligibility
Key inclusion criteria
All participants will be General Practitioners (primary care)
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose of the study
Educational / counselling / training
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
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
1/10/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319438 0
Government body
Name [1] 319438 0
Alcohol and Drug Research Innovation Agenda (ADRIA)
Country [1] 319438 0
Australia
Primary sponsor type
Other
Name
Reconnexion
Address
Country
Australia
Secondary sponsor category [1] 321929 0
University
Name [1] 321929 0
Deakin University School of Psychology
Address [1] 321929 0
Country [1] 321929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318009 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 318009 0
Ethics committee country [1] 318009 0
Australia
Date submitted for ethics approval [1] 318009 0
01/06/2024
Approval date [1] 318009 0
14/08/2024
Ethics approval number [1] 318009 0

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

Contacts
Principal investigator
Name 142862 0
Prof Petra Steiger
Address 142862 0
Deakin University Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125
Country 142862 0
Australia
Phone 142862 0
+61 392446876
Fax 142862 0
Email 142862 0
[email protected]
Contact person for public queries
Name 142863 0
Dr Erin Oldenhof
Address 142863 0
Reconnexion, 1939 Malvern Road, Malvern East, Victoria, 3145
Country 142863 0
Australia
Phone 142863 0
+61 1300273266
Fax 142863 0
Email 142863 0
[email protected]
Contact person for scientific queries
Name 142864 0
Professor Petra Steiger
Address 142864 0
Deakin University Melbourne Burwood Campus, 221 Burwood Highway, Burwood, Victoria 3125
Country 142864 0
Australia
Phone 142864 0
+61 392446876
Fax 142864 0
Email 142864 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.