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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: 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 l CONDITION: Mental Health ‐ Addiction Public Health ‐ Health promotion/education Tobacco smoking; ; Tobacco smoking PRIMARY OUTCOME: 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?'; [Weeks 4, 8, 12, 16, 20, 26 (Primary outcome), 52 and 78 after Phase 1 commencement.] 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. SECONDARY OUTCOME: Consistency in the delivery of Phase 1 small group interventions using a tool developed by the study team. [Cumulative data will be assessed at the completion of Phase 1.] Cost‐effectiveness measured using the EQ‐5D‐5L Quality of Life tool to determine changes in Quality‐Adjusted Life Years (QALYs) between groups.[Baseline then at 6, 12 and 18 months after Phase 1 commencement.] Equanimity levels using Equanimity Scale‐16 (ES‐16)[Baseline then weeks 7, 13, 20. 52 and 78 weeks after Phase 1 commencement.] External resilience as measured by ENRICHD Social Support Instrument (ESSI)[Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.] Fagerstrom test for nicotine dependency[Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.] Internal resilience measured using Connor‐Davidson Resilience Scale‐25 (CD‐RISC‐25) ; [Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.] Motivation to quit smoking using Biener and Abrams Contemplation Ladder[Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.] 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.[Interviews to be conducted once only with each participant from month 8 onwards after Phase 1 commencement. ] Saliva nicotine levels using NicConfirm test from Confirm Biosciences.[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?'] Self‐efficacy as measured by Smoking‐Abstinence Self‐Efficacy Questionnaire (SASEQ)[Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.] Stress as measured by Perceived Stress Scale‐10 (PSS‐10)[Baseline then at 3, 6, 9, 12 and 18 months after Phase 1 commencement.]
Epistemonikos ID: 06973c14c7a8229893462b41469fa8056364b9be
First added on: Aug 25, 2024