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Trial registered on ANZCTR


Registration number
ACTRN12621000445875
Ethics application status
Approved
Date submitted
10/03/2021
Date registered
19/04/2021
Date last updated
27/05/2024
Date data sharing statement initially provided
19/04/2021
Date results provided
27/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of cognitive, behavioural and mindfulness-based interventions on smoking rates in lower socio-economic groups.
Scientific title
Investigating the effect of cognitive, behavioural and mindfulness-based interventions related to resilience on smoking rates in adults in lower socio-economic groups.
Secondary ID [1] 302881 0
Nil known
Universal Trial Number (UTN)
U1111-1261-8951
Trial acronym
RISC-Resilience Interventions for Smoking Cessation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 319879 0
Condition category
Condition code
Public Health 317817 317817 0 0
Health promotion/education
Mental Health 319332 319332 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will primarily undertake a quantitative methodological approach with a parallel RCT design. Once consented, participants will be randomised to one of four groups: 1.) Arm 1-Mindfulness-integrated CBT (MiCBT) plus peer-support; 2.) Arm 2-Mindfulness Training (MT) plus peer-support, 3.) Arm 3-Setting Realistic Goals (SRG) plus peer-support 4.) Control.

This study comprises 3 distinct phases:
Phase 1 (Months 0-6): Small group intervention phase
Phase 2 (Months 7-12): Peer mentoring intervention phase
Phase 3 (Months 13-18): Maintenance phase. No intervention. Data collection only.

Arm 1 (MiCBT)-In Phase 1 (Months 0-6), participants will be involved in 8 x 1 hour online small group sessions with a maximum of 5 other participants. The content of these sessions will cover the MiCBT method and how to apply this method to smoking cessation. These sessions will be delivered at weeks: 1, 3, 5, 7, 9, 13, 17 and 20. During this phase, participants will also be encouraged to complete 2 x daily practice of mindfulness sessions on their own which will take a total duration of approximately 30-60 minutes/day. To facilitate this, participants in Arm 1 will be provided with a mobile phone app which provides guided mindfulness exercises. In Phase 2 (Months 7-12), participants will join an online peer mentoring forum with other Arm 1 participants via a blog which will be facilitated by ex-smoker peer mentors. Participants will be encouraged to interact with the blog weekly. As a minimum, participants will be asked to react to posts or post their own comment at least once/week. Peer mentors will promote discussion of specified topics and content including: the lived experience of quitting cigarettes; managing triggers and relapses; and how to translate learnings from Phase 1 into everyday lives. During Phase 2, participants will also be encouraged to use the mobile phone app to continue with the 2 x daily mindfulness sessions on their own. The intervention period will be completed at the end of Month 12. In Phase 3, the maintenance phase, participants will not be required to participate in any specific activities but will be able to use or not use the strategies/support provided during Phases 1 and 2 as they desire. Final data collection will then occur at the end of Phase 3, the maintenance phase (Months 13-18).

Arm 2 (MT)-In Phase 1 (Months 0-6), participants will be involved in 8 x 1 hour online small group sessions with a maximum of 5 other participants. The content of these sessions will cover the MT method and how to apply this method to smoking cessation. These sessions will be delivered at weeks: 1, 3, 5, 7, 9, 13, 17 and 20. During this phase, participants will also be encouraged to complete 2 x daily practice of mindfulness sessions on their own which will take a total duration of approximately 30-60 minutes/day. To facilitate this, participants in Arm 2 will be provided with a mobile phone app which provides guided mindfulness exercises. In Phase 2 (Months 7-12), participants will join an online peer mentoring forum with other Arm 2 participants via a blog which will be facilitated by ex-smoker peer mentors. Participants will be encouraged to interact with the blog weekly. As a minimum, participants will be asked to react to posts or post their own comment at least once/week. Peer mentors will promote discussion of specified topics and content including: the lived experience of quitting cigarettes; managing triggers and relapses; and how to translate learnings from Phase 1 into everyday lives. During Phase 2, participants will also be encouraged to use the mobile phone app to continue with the 2 x daily mindfulness sessions on their own. The intervention period will be completed at the end of Month 12. In Phase 3, the maintenance phase, participants will not be required to participate in any specific activities but will be able to use or not use the strategies/support provided during Phases 1 and 2 as they desire. Final data collection will then occur at the end of Phase 3, the maintenance phase (Months 13-18).

Arm 3 (SRG)-In Phase 1 (Months 0-6), participants will be involved in 8 x 1 hour online small group sessions with a maximum of 5 other participants. The content of these sessions will cover the SRG method and how to apply this method to smoking cessation. These sessions will be delivered at weeks: 1, 3, 5, 7, 9, 13, 17 and 20. In Phase 2 (Months 7-12), participants will join an online peer mentoring forum with other Arm 3 participants via a blog which will be facilitated by ex-smoker peer mentors. Participants will be encouraged to interact with the blog weekly. As a minimum, participants will be asked to react to posts or post their own comment at least once/week. Peer mentors will promote discussion of specified topics and content including: the lived experience of quitting cigarettes; managing triggers and relapses; and how to translate learnings from Phase 1 into everyday lives. The intervention period will be completed at the end of Month 12. In Phase 3, the maintenance phase, participants will not be required to participate in any specific activities but will be able to use or not use the strategies/support provided during Phases 1 and 2 as they desire. Final data collection will then occur at the end of Phase 3, the maintenance phase (Months 13-18).

For Arms 1-3, strategies to monitor adherence to the interventions will include session attendance checklists for Phase 1 and interaction with the blog according to the requested minimum amount (react to posts or post their own comment at least once per week) for Phase 2. For Arms 1 and 2, mobile phone app use will also be used to monitor adherence to the interventions throughout Phases 1 and 2.

The online delivery of the small group sessions will be via Zoom. Participants will be asked to provide approval for their small group session to be audio recorded. This will enable qualitative analysis of intervention delivery fidelity.

Facilitators of the small group sessions will have formal qualifications in psychology and will have also received specific training via the Flinders key study intervention experts on the MiCBT, MT and SRG interventions used in this study.

Participants in all 3 arms will also be invited to opt-in to be referred to their local Quitline service as part of the Royal Australian College of General Practitioner’s 'Ask, Advise, Help' model for smoking cessation. Participants will also be provided with a link to the written materials contained in the National Quitline Quitpack which includes information on accessing Nicotine Replacement Therapy and stop-smoking medications.

At the end of Phase 1, participants in Arms 1-3 will also be invited to participate in a 1 x 1 hour qualitative interview with a member of the study team to determine barriers and enablers to participation in the study. 15 participants from each arm will be randomly selected for this qualitative component, giving a total of 45 participants.

All intervention group participants in Phase 2 will be asked to participate in a 10-minute semi-structured phone interview to understand their experiences of the Blog.

Intervention code [1] 319886 0
Behaviour
Comparator / control treatment
Active control group: Participants in this group will be invited to opt-in to be referred to their local Quitline service as part of the Royal Australian College of General Practitioner’s 'Ask, Advise, Help' model for smoking cessation. Participants in this group will also be provided with a link to the written materials contained in the National Quitline Quitpack which includes information on accessing Nicotine Replacement Therapy and stop-smoking medications.

Control group participants will complete data collection questionnaires for the study at the same timepoints as the intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 326554 0
Quit smoking outcome as measured by repeated 7-day point prevalence data gathered in response to the question: 'In the last 7 days, have you smoked a cigarette, even a puff?'
Timepoint [1] 326554 0
Weeks 4, 8, 12, 16, 20, 26 (Primary outcome), 52 and 78 after Phase 1 commencement.
Secondary outcome [1] 392473 0
Internal resilience measured using Connor-Davidson Resilience Scale-25 (CD-RISC-25)
Timepoint [1] 392473 0
Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.
Secondary outcome [2] 392474 0
Cost-effectiveness measured using the EQ-5D-5L Quality of Life tool to determine changes in Quality-Adjusted Life Years (QALYs) between groups.
Timepoint [2] 392474 0
Baseline then at 6, 12 and 18 months after Phase 1 commencement.
Secondary outcome [3] 392715 0
Self-efficacy as measured by Smoking-Abstinence Self-Efficacy Questionnaire (SASEQ)
Timepoint [3] 392715 0
Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.
Secondary outcome [4] 392718 0
External resilience as measured by ENRICHD Social Support Instrument (ESSI)
Timepoint [4] 392718 0
Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.
Secondary outcome [5] 392719 0
Motivation to quit smoking using Biener and Abrams Contemplation Ladder
Timepoint [5] 392719 0
Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.
Secondary outcome [6] 392720 0
Fagerstrom test for nicotine dependency
Timepoint [6] 392720 0
Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.
Secondary outcome [7] 392721 0
Equanimity levels using Equanimity Scale-16 (ES-16)
Timepoint [7] 392721 0
Baseline then weeks 7, 13, 20. 52 and 78 weeks after Phase 1 commencement.
Secondary outcome [8] 392723 0
Stress as measured by Perceived Stress Scale-10 (PSS-10)
Timepoint [8] 392723 0
Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.
Secondary outcome [9] 392724 0
Saliva nicotine levels using NicConfirm test from Confirm Biosciences.
Timepoint [9] 392724 0
Will be requested from study participants if they self-report that they have quit smoking in response to the primary outcome question: 'In the last 7 days, have you smoked a cigarette, even a puff?'
Secondary outcome [10] 392732 0
Qualitative data will be collected during interviews with a subset of participants (n=45) exploring barriers and enablers to participation in the study with an interview tool designed by the study team.
Timepoint [10] 392732 0
Interviews to be conducted once only with each participant from months 8-12 months onwards after Phase 1 commencement.
Secondary outcome [11] 392733 0
Consistency in the delivery of Phase 1 small group interventions using a tool developed by the study team.
Timepoint [11] 392733 0
Cumulative data will be assessed at the completion of Phase 1.
Secondary outcome [12] 413782 0
A sample of intervention group participants will be asked to participate in a 10-minute phone interview to understand their experiences of the Blog.
Timepoint [12] 413782 0
During the early stages of Phase 2 (1-2 months from Phase 2 commencement).

Eligibility
Key inclusion criteria
• Adult smokers aged 18 years or above
• Regular smoker for at least the last 2 years as assessed by the following question: ‘Are you a regular smoker (i.e. you have usually smoked at least 1 cigarette per day for at least the last 2 years)?’
• Has a household income of <=$457 per adult per week
• Is planning to quit cigarettes, as assessed by the following question: 'Are you currently planning to quit smoking cigarettes?'
• Willing to spend approximately 14-20 hours online to complete the study over an 18 month period.
• Has a smartphone and regular access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Children and adolescents (under the age of 18 years of age)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, allocation concealment will be used. Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome of smoking cessation, a sample size of 203 per 4 groups (N=812) is required to provide 80% power to detect a reduction of 11.6% (Oikonomou, 2016) in smoking rates for the intervention compared to controls, Type 1 error rate/ alpha=.05.

Mixed-effects modelling will be applied to assess the effect of the intervention on primary and secondary outcomes. For outcomes assessed at a single time-point, the difference between groups at that time will be assessed. For outcomes assessed at repeated time points, differences between groups at each time-point will be assessed, with adjustment for multiple comparisons. The statistical analysis will test whether the level of resilience in participants has an influence on whether they are more likely to quit smoking.

For the cost-effectiveness assessment, a published Markov model will be utilised to assess the Quality-Adjusted Life Years (QALY).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2021
Actual
3/05/2021
Date of last participant enrolment
Anticipated
30/04/2023
Actual
31/03/2023
Date of last data collection
Anticipated
30/04/2024
Actual
2/05/2024
Sample size
Target
812
Accrual to date
Final
644
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307300 0
Government body
Name [1] 307300 0
Cancer Australia
Country [1] 307300 0
Australia
Funding source category [2] 308027 0
Charities/Societies/Foundations
Name [2] 308027 0
Flinders Foundation
Country [2] 308027 0
Australia
Primary sponsor type
University
Name
Torrens University, Australia
Address
Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 308749 0
None
Name [1] 308749 0
Address [1] 308749 0
Country [1] 308749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307396 0
Southern Adelaide Clinical Human Research Ethics Committee (SACHREC)
Ethics committee address [1] 307396 0
Ethics committee country [1] 307396 0
Australia
Date submitted for ethics approval [1] 307396 0
Approval date [1] 307396 0
12/12/2019
Ethics approval number [1] 307396 0
270.19

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

Contacts
Principal investigator
Name 107086 0
Prof Paul Ward
Address 107086 0
Torrens University Australia, Director, Research Centre for Public Health, Equity and Human Flourishing, Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000
Country 107086 0
Australia
Phone 107086 0
+61 0434 187054
Fax 107086 0
Email 107086 0
paul.ward@torrens.edu.au
Contact person for public queries
Name 107087 0
Elissa Mortimer
Address 107087 0
Torrens University Australia, Research Centre for Public Health, Equity and Human Flourishing, Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000
Country 107087 0
Australia
Phone 107087 0
+61 0415 216 907
Fax 107087 0
Email 107087 0
elissa.mortimer@torrens.edu.au
Contact person for scientific queries
Name 107088 0
Elissa Mortimer
Address 107088 0
Torrens University Australia, Research Centre for Public Health, Equity and Human Flourishing, Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000
Country 107088 0
Australia
Phone 107088 0
+61 0415 216 907
Fax 107088 0
Email 107088 0
elissa.mortimer@torrens.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?
Raw de-identified individual participant data of primary outcomes only
When will data be available (start and end dates)?
June 2023-2024
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To achieve the aims in the proposal discussed with the Primary Sponsor.
How or where can data be obtained?
By email request to the Chief Investigator A, Professor Paul Ward: paul.ward@flinders.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10885Ethical approval    381007-(Uploaded-04-03-2021-15-05-47)-Study-related document.pdf
23752Study protocolDe Zylva R, Mortimer E, Miller E, Tsourtos G, Lawn E, Wilson C, Karnon J, Woodman R, Ward P. Efficacy of mindfulness and goal setting interventions for increasing resilience and reducing smoking in lower socio-economic groups: randomised controlled trial protocol. Addiction Science & Clinical Practice 2023; 18:7. https://doi.org/10.1186/s13722-022-00355-whttps://doi.org/10.1186/s13722-022-00355-w 



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Early preliminary analyses indicate a non-signific... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of mindfulness and goal setting interventions for increasing resilience and reducing smoking in lower socio-economic groups: randomised controlled trial protocol.2023https://dx.doi.org/10.1186/s13722-022-00355-w
N.B. These documents automatically identified may not have been verified by the study sponsor.