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Investigating the effect of cognitive, behavioural and mindfulness-based interventions on smoking rates in lower socio-economic groups.

Investigating the effect of cognitive, behavioural and mindfulness-based interventions related to resilience on smoking rates in adults in lower socio-economic groups.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000445875
Acronym
RISC-Resilience Interventions for Smoking Cessation
Enrollment
644
Registered
2021-04-19
Start date
2021-05-03
Completion date
2023-03-31
Last updated
2024-06-03

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

Conditions

None listed

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.

Interventions

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 int

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.

Sponsors

Torrens University, Australia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

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

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.

Exclusion criteria

• Children and adolescents (under the age of 18 years of age)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026