ANZCTR - Registration

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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 information initially 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]

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

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

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]

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]

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]

Weeks 4, 8, 12, 16, 20, 26 (Primary outcome), 52 and 78 after Phase 1 commencement.

Secondary outcome [1]

Internal resilience measured using Connor-Davidson Resilience Scale-25 (CD-RISC-25)

Timepoint [1]

Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.

Secondary outcome [2]

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]

Baseline then at 6, 12 and 18 months after Phase 1 commencement.

Secondary outcome [3]

Self-efficacy as measured by Smoking-Abstinence Self-Efficacy Questionnaire (SASEQ)

Timepoint [3]

Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.

Secondary outcome [4]

External resilience as measured by ENRICHD Social Support Instrument (ESSI)

Timepoint [4]

Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.

Secondary outcome [5]

Motivation to quit smoking using Biener and Abrams Contemplation Ladder

Timepoint [5]

Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.

Secondary outcome [6]

Fagerstrom test for nicotine dependency

Timepoint [6]

Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.

Secondary outcome [7]

Equanimity levels using Equanimity Scale-16 (ES-16)

Timepoint [7]

Baseline then weeks 7, 13, 20. 52 and 78 weeks after Phase 1 commencement.

Secondary outcome [8]

Stress as measured by Perceived Stress Scale-10 (PSS-10)

Timepoint [8]

Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.

Secondary outcome [9]

Saliva nicotine levels using NicConfirm test from Confirm Biosciences.

Timepoint [9]

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]

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]

Interviews to be conducted once only with each participant from months 8-12 months onwards after Phase 1 commencement.

Secondary outcome [11]

Consistency in the delivery of Phase 1 small group interventions using a tool developed by the study team.

Timepoint [11]

Cumulative data will be assessed at the completion of Phase 1.

Secondary outcome [12]

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]

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?

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]

Government body

Name [1]

Cancer Australia

Address [1]

Locked Bag 3, Strawberry Hills
NSW 2012

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Flinders Foundation

Address [2]

Flinders Foundation
Flinders Drive
Bedford Park
SA 5042

Country [2]

Australia

Primary sponsor type

University

Name

Torrens University, Australia

Address

Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee (SACHREC)

Ethics committee address [1]

Flinders Medical Centre,
Ward 6C, Room 6A219
Flinders Drive
Bedford Park
SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/12/2019

Ethics approval number [1]

270.19

Summary

Brief summary

Overall study hypothesis: That increasing levels of resilience for low socio-economic status (SES) smokers who are contemplating quitting will help them quit smoking cigarettes.

This study is likely to have an impact on improving the poorer health of lower SES populations by reducing smoking and increasing resilience, mental wellbeing, confidence, self-esteem and self-efficacy. This will address the high smoking prevalence rates in lower SES areas and the limited number of studies that have addressed this health problem in this target population. The cost-effectiveness analysis of the interventions will also provide important information to policy-makers.

This study will utilise a Randomised Controlled Trial (RCT) design with one control group and three intervention groups. Once consented, participants will be randomised to one of these 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 will enable the study to determine which of the interventions works best when compared to the control group and also when compared to each other.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Paul Ward

Address

Torrens University Australia, Director, Research Centre for Public Health, Equity and Human Flourishing, Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000

Country

Australia

Phone

+61 0434 187054

Fax

paul.ward@torrens.edu.au

Contact person for public queries

Name

Ms Elissa Mortimer

Address

Torrens University Australia, Research Centre for Public Health, Equity and Human Flourishing, Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000

Country

Australia

Phone

+61 0415 216 907

Fax

elissa.mortimer@torrens.edu.au

Contact person for scientific queries

Name

Ms Elissa Mortimer

Address

Torrens University Australia, Research Centre for Public Health, Equity and Human Flourishing, Adelaide Campus: 88 Wakefield Street
Adelaide, SA 5000

Country

Australia

Phone

+61 0415 216 907

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
10885	Ethical approval					381007-(Uploaded-04-03-2021-15-05-47)-Study-related document.pdf
23752	Study protocol	De 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-w	https://doi.org/10.1186/s13722-022-00355-w

Results publications and other study-related documents

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Current Study Results

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Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4157	Plain language summary	No		Early preliminary analyses indicate a non-signific... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy of mindfulness and goal setting interventions for increasing resilience and reducing smoking in lower socio-economic groups: randomised controlled trial protocol.	2023	https://dx.doi.org/10.1186/s13722-022-00355-w

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