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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.

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.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000825459
Enrollment
24
Registered
2025-08-01
Start date
2025-10-31
Completion date
2025-12-05
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to co-design BCT intervention to support smoking and vaping cessation that is easy to use, acceptable, and tailored to the needs of mental health consumers.

Interventions

- 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

- 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.

Sponsors

University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: May 7, 2026