A randomised controlled trial to assess the effectiveness of the Breaking Free from Smoking online intervention for offenders in UK prisons

INTERVENTION: Participants will be assigned to one of the study groups following the generation of a random allocation sequence via the Research Randomizer (from the Social Psychology Network‐ Urbaniak and Plous, 2011), which uses the “Math. Random” method within the JavaScript programming language for web browsers. The sponsor’s authorised personnel will prepare the sequentially numbered opaque sealed envelopes containing the treatment group that the participant will be allocated to. The sealed envelopes will be delivered by the principal investigator to the research sites prior to commencement of the study. The participant number will be determined according to the order of enrolment in the study. The site investigator or service worker will assign and open one sealed envelope, containing the type of treatment, with the participant on the day of screening. This way, investigational site and participant will be aware of the treatment to follow from the day of screening (no blinding is applicable). Participants will be allocated randomly to either an active control (standard stop smoking behavioural and medication based support only) or intervention group (BFS online programme, plus the standard stop smoking programme) on the first session of the standard stop smoking programme in prison. The intervention group will receive the same standard prison smoking cessation support as the participants in the control group, including standard prison smoking cessation support and stop smoking medication. In addition to this, participants who are randomly assigned to the intervention group will also complete the internet‐based Breaking Free from Smoking programme. The control group will receive standard prison smoking cessation support, which incorporates evidence‐based behavioural support as specified by the National Centre for Smoking Cessation Training (NCSCT), alongside stop smoking medications (e.g., nicotine patches, lozenges). Both programmes last for a 12‐week duration and re CONDITION: Smoking cessation ; Mental and Behavioural Disorders ; Mental and behavioural disorders due to use of tobacco PRIMARY OUTCOME: Self‐reported smoking at baseline, following treatment engagement at 8 weeks, then at 3 months and 6 months follow‐up SECONDARY OUTCOME: Measured at baseline, following the 8‐week intervention period, and at 3 and 6 months follow‐up:; 1. Quality of life, measured using two items from the World Health Organisation Quality of Life scale (WHOQOL‐BREF); 2. Biopsychosocial functioning, measured using six items from the Recovery Progression Measure (RPM); INCLUSION CRITERIA: 1. Aged 18 years and over 2. Currently smoking tobacco 3. Attending the standard stop smoking programme 4. Willing to make a quit attempt in the next 14 days 5. Willing to complete the assessment measures 6. Willing to complete an online programme 7. Able to read and understand materials written in the English language 8. Not scheduled for release within 12 weeks of enrolment to the study