None listed
Conditions
Brief summary
It is currently unclear whether there is a benefit for smokers to act immediately on impulses to quit smoking, and if so, whether delay is detrimental in its own right, or only if the time is not used productively for appropriate planning. It is also unclear whether planning can effectively be carried out after quitting, allowing smokers to quit spontaneously yet still effectively plan for the maintenance of their attempt. The study is designed to untangle these issues, specifically exploring the benefit of structured support and the possible positive effects of recommending immediate implementation, apart from any delay required by the help to be used (e.g., medications that need to be used for a period before quitting). We hypothesize that among smokers who seek help, 6-month sustained abstinence assessed on an intention-to-treat basis will be greater among: 1. Those encouraged to quit immediately as compared with those encouraged to quit to their own timetable; 2. Those who are provided with a structured planning program based around the development of implementation intentions (if-then statements designed to increase the likelihood that a goal is attained), as compared with those only provided motivational messages and general encouragement to plan; 3. And that these two effects will be independent. We will also explore the outcomes as a function of compliance with the recommended strategies, and whether the trial outcomes differ for different outcome measures (e.g. point-prevalence cessation, different imputation strategies for dealing with missing cases).
Interventions
The study is a 2x2 crossover trial, with participants allocated to intervention or control on both of the following arms:
Arm 1: Immediate implementation: In this arm smokers will be encouraged (recommended) to quit immediately, or as soon as practically possible (e.g., if they need to obtain medication or use it for a period before actually quitting). Those who have already decided to quit will be encouraged to implement their decision immediately. Others will be encouraged to take the next st
The study is a 2x2 crossover trial, with participants allocated to intervention or control on both of the following arms: Arm 1: Immediate implementation: In this arm smokers will be encouraged (recommended) to quit immediately, or as soon as practically possible (e.g., if they need to obtain medication or use it for a period before actually quitting). Those who have already decided to quit will be encouraged to implement their decision immediately. Others will be encouraged to take the next step toward quitting as soon as possible (this may involve getting medication), and implement the quit attempt immediately they have done so. These recommendations will take place via questions in the automated QuitCoach assessment, each time the participant completes the assesment. The control aspect of this is to quit in their own time, without any systematic encouragement to bring it forward. Arm 2: Structured Planning intervention: The structured planning augmentation of the QuitCoach will consist of highly prescriptive instructions for planning a quit attempt. Key aspects of the structured planning intervention are informed by the theory of implementation intentions. It will be delivered via modifications and additions to the basic QuitCoach tailored advice, and through a section of the QuitCoach website containing a set of tools to facilitate implementation. The control condition will receive the basic QuitCoach. Participants can be randomised to either: No immediate implementation nor structured planning; no immediate implementation but receiving structured planning; receiving recommendation to quit immediately but no structured planning; or receiving both interventions. Regardless of to which of the four possible study arms the participant has been randomised, frequency of use of the QuitCoach is at the discretion of the participant. Thus, there is no set endpoint for delivery of the intervention. All participants will be reminded to return via emails sent periodically over several weeks and scheduled according to their readiness to quit, but we anticipate that most will complete the assessment only once (when they join the study). It is possible that those allocated to receive the structured planning intervention will return more frequently, as for this group the QuitCoach will include a greater selection of tools potentially motivating return.
Sponsors
Ron Borland
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Smokers who want to quit, who are using the QuitCoach, and at recruitment have not committed to a quit attempt in the next day (Rapid Implementation arm) or had quit for up to 4 days (Structured Planning arm)
Exclusion criteria
Non-smokers, ex-smokers, people not ready to quit (defined as reporting not planning to make a quit attempt in the next month), or quit for more than 4 days, and those reporting a mental health condition for which they are taking medication.
Outcome results
None listed