Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000825459
Ethics application status
Approved
Date submitted
24/06/2025
Date registered
1/08/2025
Date last updated
1/08/2025
Date data sharing statement initially provided
1/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Co-design of an acceptable and user-friendly smoking and vaping cessation intervention that uses Behaviour Change Techniques (BCTs) to optimise the likelihood of achieving sustained abstinence among mental health consumers.
Scientific title
Co-design of an acceptable and user-friendly smoking and vaping cessation intervention that uses Behaviour Change Techniques (BCTs) to optimise the likelihood of achieving sustained abstinence among mental health consumers.
Secondary ID [1] 314700 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 337883 0
Vaping 337884 0
Mental health 338034 0
Condition category
Condition code
Mental Health 334214 334214 0 0
Psychosis and personality disorders
Mental Health 334215 334215 0 0
Depression
Mental Health 334216 334216 0 0
Anxiety
Mental Health 334217 334217 0 0
Schizophrenia
Mental Health 334263 334263 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- This study is being conducted as a part of MPhil Research degree by research student under the supervision and guidance by supervisors and the research team.

- This is a mixed method study involving one-on-one qualitative interviews including quantitative survey questions to co-design a smoking and vaping cessation intervention using Behaviour Change Techniques (BCTs).
Please note: The specific details of the intervention are not known at this time, as they will be developed as part of this study (as per methodology described below).

- Mental health consumers, mental health professionals, and stakeholders (n=24, 8 from each group) will be involved in the co-design process through one-on-one interviews lasting 45-60 minutes.

- Semi-structured interview guides will be used to guide the discussion. This project will use theoretical frameworks to inform development and evaluation of the intervention. The moderator guides for the interviews include questions and probes in line with these frameworks, The Behavior Change Wheel (BCW) used in conjunction with the Capability, Opportunity, and Motivation of Behaviors (COM-B) model will be used to identify perceived enablers and barriers to use of quit smoking and vaping interventions delivered within inpatient mental health units. The Theoretical Domains Framework (TDF) will be used to examine contextual factors that contribute to a behavior, and guide selection of BCTs during intervention development. Behaviour change techniques include motivational interviewing, counselling, cognitive-behavioural therapy, incentives, goal setting, social/peer support etc. Demographic information will be collected at the start of the interview, including any current use of potential confounders such as Nicotine Replacement Therapy (NRT). The next part of the interview will examine perceived barriers and enablers to use of smoking and vaping cessation interventions within the inpatient mental health setting. At approximately the halfway mark, the prototype smoking/vaping cessation intervention will be shown to participants via Miro and Microsoft 365 software (approximately 5-minutes to demonstrate). The second half of the qualitative interview will ask questions about perceived acceptability of the proposed smoking/vaping cessation intervention. Perceived usability of the intervention will also be explored using System Usability Scale and how it can be optimised for use within the mental health inpatient setting.

- Prototype intervention development: The initial intervention will be developed by taking key BCTs identified through a systematic review to produce the version 1 prototype. This will be shown to participants at the halfway mark of their interviews via wireframe mapping and content outlines using Miro and Microsoft 365 software. After the first round of n=8 interviews, participant feedback from that initial iteration will be incorporated into the prototype demonstration for presentation with the next round of participant interviews. This process will be undertaken using the Plan, Do, Study, Act (PDSA) Cycle as a guiding framework.

- Data extraction: Interviews will be audio-recorded using video conferencing software or via external and secured audio recording devices. Verbatim transcripts will be produced using Rev.com automated software. Transcripts will be reviewed for accuracy against the audio recordings, and participants will be de-identified within the transcripts at this stage, before data analysis. Quantitative data will be extracted into an excel spreadsheet, using the same matched deidentification practice performed when coding and deidentifying interview transcripts.




Intervention code [1] 331306 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341876 0
- To identify perceived barriers and enablers to use of quit smoking and vaping interventions delivered within inpatient mental health units.
Timepoint [1] 341876 0
This is a single-instance data collection with the participants by the research team.
Primary outcome [2] 342022 0
- To identify perceived intervention usability.
Timepoint [2] 342022 0
This is a single-instance data collection with the participants by the research team.
Primary outcome [3] 342347 0
- To identify perceived intervention acceptability.
Timepoint [3] 342347 0
This is a single-instance data collection with the participants by the research team.
Secondary outcome [1] 448853 0
Nil
Timepoint [1] 448853 0
Nil

Eligibility
Key inclusion criteria
Participants
o Key Stakeholders: Mental health directors, Managers
o Mental Health Professionals: Psychiatrists, Doctors, Psychologists, Nurses, Allied Health Professionals, Pharmacists
o Mental Health Consumers: Consumers admitted to adult mental health units at Lyell McEwin Hospital

Inclusion will not be restricted by ethnicity or cultural backgrounds. Individuals meeting all specified inclusion criteria will be eligible for the study, including those of Aboriginal or Torres Strait Islander descent.


Eligibility Criteria
Key Stakeholders
Inclusion
• Provides informed consent
• Working in a participating mental health site
• Policy leader, clinical practice manager, or content expert


Mental Health Professionals
Inclusion criteria
• Provides informed consent
• Working in a participating Northern Adelaide Local Health Network (NALHN) mental health site
• Psychiatrist, Doctors, Psychologist, Nurses, Allied Health Professionals, Pharmacist



Mental Health Consumers
Inclusion criteria
• Current daily smokers/vapers
• Provides informed consent
• Minimum 18 years old
• Admitted or previously admitted to the hospital’s mental health unit
• Deemed clinically safe to participate by a treating health professional





Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key Stakeholders
Exclusion
• Limited or no English
• Unwilling to participate


Mental Health Professionals
Exclusion criteria
• Limited or no English
• Unwilling to participate


Mental Health Consumers
Exclusion criteria
• Limited or no English
• Unwilling to participate
• Not clinically appropriate determined by mental health professionals based on Mental State Examination and risk assessment

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
Interviews will be audio-recorded using video conferencing software or via external and secured audio recording devices. Verbatim transcripts will be produced using Rev.com automated software,

- Data analysis and synthesis: NVivo 2022 software will be used to aid in data synthesis for both interview and survey data. Two independent researchers will code the transcripts using inductive thematic analysis to identify barriers and enablers, and to identify how the proposed smoking/vaping intervention should be delivered in a future pilot and feasibility study to be undertaken in the Mental Health Units. A codebook will be produced based on themes developed through the independent review process. Data from independent coding will be compared and allocation to themes discussed between researchers to produce a consensus. Where necessary, a third-party arbiter will be used to resolve any disagreements (e.g., Principal Supervisor KVC). Findings will be narratively synthesized within themes and presented in a tabulated format against pre-specified frameworks.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2025
Actual
Date of last participant enrolment
Anticipated
5/12/2025
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 28120 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 44324 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 319250 0
University
Name [1] 319250 0
University of Adelaide and Houd Research Group scholarship (Industry Partnership)
Country [1] 319250 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 321722 0
Commercial sector/Industry
Name [1] 321722 0
University of Adelaide and Houd Research Group scholarship (Industry Partnership)
Address [1] 321722 0
Country [1] 321722 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317830 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [1] 317830 0
Ethics committee country [1] 317830 0
Australia
Date submitted for ethics approval [1] 317830 0
27/11/2024
Approval date [1] 317830 0
02/04/2025
Ethics approval number [1] 317830 0
2024/HRE00297
Ethics committee name [2] 317831 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 317831 0
Ethics committee country [2] 317831 0
Australia
Date submitted for ethics approval [2] 317831 0
10/04/2025
Approval date [2] 317831 0
14/05/2025
Ethics approval number [2] 317831 0
40559

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

Contacts
Principal investigator
Name 142290 0
Mrs Pabitra Thapa
Address 142290 0
MPhil Research candidate at University of Adelaide, Adelaide Medical School- 4 North Terrace, Adelaide, SA, 5000
Country 142290 0
Australia
Phone 142290 0
+61 424194565
Fax 142290 0
Email 142290 0
[email protected]
Contact person for public queries
Name 142291 0
Kristin Carson-Chahhoud
Address 142291 0
A/Prof at University of Adelaide, Adelaide Medical School, 4 North Terrace, Adelaide, SA, 5000
Country 142291 0
Australia
Phone 142291 0
+61 412708879
Fax 142291 0
Email 142291 0
[email protected]
Contact person for scientific queries
Name 142292 0
Kristin Carson-Chahhoud
Address 142292 0
A/Prof at University of Adelaide, Adelaide Medical School, 4 North Terrace, Adelaide, SA, 5000
Country 142292 0
Australia
Phone 142292 0
+61 412708879
Fax 142292 0
Email 142292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: De-identified individual participant data will not be available for this study.

All the data will be in digital form which will be stored in the secure University of Adelaide server, in a password-protected database, only accessible to people named on the approved ethics application. All data used for analysis will be deidentified. All identifiable data will be deleted in accordance with University and Ethics requirements to preserve anonymity of research participants. Data will be stored for a period of 15-years after the research has been completed, and electronic records wiped by deleted all content at least seven times from the source to ensure permanent removal of the files.


Reports finalized after the study will be presented to stakeholders and mental health professionals. Participants will be notified of publications and sent a copy if they consent during interviews to receive the report findings, or if they contact the research team after the findings are ready. Outcome papers will be submitted to peer reviewed journals for publication.




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.