JMIR Publications

ABSTRACT

Background:

Stopping smoking can improve mental health, with effect sizes similar to antidepressant treatment. Internet-based cognitive behavioural therapy (iCBT) provides evidence-based treatment for depression and anxiety, and online interventions can support smoking cessation. However, combined online smoking and mental health support is not currently available in UK health services.

Objective:

This feasibility trial aimed to investigate the acceptability and feasibility of an online tailored smoking cessation intervention delivered alongside usual iCBT, and test trial procedures.

Methods:

The study design was a two-armed, parallel groups, pragmatic, feasibility randomised controlled trial (RCT). Eligible participants were adult (18+), regular smokers referred to iCBT from National Health Service (NHS) Talking Therapies services in England. Participants were screened, consented, and randomised online and allocated to intervention (integrated smoking cessation support) or control (usual care) arms. Automated processes ensured allocation concealment. It was not possible to blind participants or clinicians to the behavioural intervention. Follow-ups were completed at 3- and 6-months. Prespecified progression criteria, to determine the feasibility of the integrated intervention and trial procedures for a definitive trial, were enrolment of eligible clients (≥20%); recruitment to target (≥80%); outcome data completeness (≥70%); and self-reported quit attempts in the intervention arm (≥8%).

Results:

309 participants were randomised: 154 to the intervention arm and 155 to the control arm between 19/05/2023 and 28/06/2024. The proportion of eligible clients enrolled (21%) met the criteria for progression; however, the number randomised was below target (62%). In the intervention arm, 18% self-reported at least one quit attempt, which exceeded the progression criteria but was comparable to the control arm (21%). High loss to follow-up meant data completeness was low (<30%).

Conclusions:

Integrating smoking cessation within online mental health treatment, and using automated procedures to enrol and randomise participants, appears feasible. Adjustments to site recruitment could improve participant recruitment; however, large loss to follow-up undermines the feasibility of progression. Clinical Trial: ISRCTN10612149 (https://doi.org/10.1186/ISRCTN10612149).