The goal of this clinical trial is to pilot an eHealth intervention (real-time telecounselling) in nicotine addiction. The main questions it aims to answer are: Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial? Researchers will compare a range of outcome measures between the active and control arms, to see if a pilot eHealth intervention can successfully treat nicotine addiction.
The goal of this clinical trial is to pilot an eHealth intervention in nicotine addiction (real-time telecounselling) . It will also attempt to better understand the psychology of nicotine addiction and craving regarding consumption behaviour. The main questions it aims to answer are: Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial? Researchers will compare outcomes pre and post intervention in the active arm, and also between active and control arms, to ascertain the treatment effect of the intervention on primary (nicotine consumption, abstinence) and secondary (self-efficacy, readiness to quit, decisional balance) measures, in tests of efficacy. Following randomisation, participants will be allocated to either the active arm or the control arm. In the active arm, participants will undergo six weekly sessions of real-time CBT-MI (Cognitive Behavioural Therapy with Motivational Interviewing), with each session lasting approximately 45 to 60 minutes. In the control arm: A Wait List Control Group (WLCG) will denote the comparator, who will undergo screening and assessment only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
CBT-MI combines elements from Cognitive Behavioural Therapy and Motivational Interviewing in treating nicotine addiction, delivered remotely via Zoom by trained 'layperson coaches'
Key contact
Leicester, Midlands, United Kingdom
RECRUITINGAbstinence status
This is a binary indicator, suggesting whether or not participants are abstinent at point of questioning
Time frame: 1 week post study: 7 days retrospective
Nicotine consumption (cigarettes, units)
Unit: Number of cigarettes consumed, on average, per day
Time frame: Baseline; 6 weeks after the intervention
Nicotine consumption (cigarettes, time)
Time: Time spent smoking nicotine, on average, per day
Time frame: Baseline; 6 weeks after the intervention
Nicotine consumption (vape, units)
Unit: Number of 15-minute 'episodes' of vaping, on average, per day
Time frame: Baseline; 6 weeks after the intervention
Nicotine consumption (vape, time)
Time: Time spent vaping nicotine, on average, per day
Time frame: Baseline; 6 weeks after the intervention
Dependence and Craving (CDS)
Cigarette dependence and craving experiences will be assessed using the Cigarette Dependence Scale (CDS), which measures various aspects of nicotine dependence, including withdrawal symptoms, desire to quit, time spent using, and the effects of consumption on activities. The scale has possible values of 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.
Time frame: Baseline; 6 weeks after the intervention
Dependence and Craving (EDS)
The (Electronic) e-Cigarette Dependence Scale (EDS) captures similar dimensions of dependence specific to e-cigarette use and will be administered at the same time points as the Cigarette Dependence Scale (CDS), which measures various aspects of nicotine dependence, including withdrawal symptoms, desire to quit, time spent using, and the effects of consumption on activities. This scale measures the level of nicotine dependence in those who use e-cigarettes or vapes. The scale has possible values of 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.
Time frame: Baseline; 6 weeks after the intervention
Readiness to Quit
Participants' readiness to quit smoking will be assessed using the contemplation ladder (CL), which measures their current stage of change in the quitting process. The Contemplation Ladder (CL) measures readiness to quit using an 11-point Likert scale, ranging from "No thoughts of quitting" (0) to "Taking action to quit" (10). he possible values of the measure were 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11. On this ordinal scale, higher values denote stronger agreement regarding readiness to quit.
Time frame: Baseline; Every week during the intervention
Perceived Smoking Abstinence Efficacy as assessed by questionnaire measuring participants' confidence in their ability to quit smoking, and their resistance to temptation to relapse
The questionnaire comprises items related to positive social situations, negative affect situations, and habitual/craving situations. Responses will be recorded on a 5-point Likert scale ranging from 'Not at all tempted' to 'Extremely tempted'. The possible values of the measure were 1, 2, 3, 4, 5, 6, 7, 8, 9. On this ordinal scale, higher values denote stronger agreement regarding self-efficacy in nicotine abstinence.
Time frame: Baseline; Every week during the intervention
Decisional balance
'Decisional balance' evaluates the pros and cons of nicotine consumption and quitting. This scale measures participant's relative weighing of the pros and cons of smoking/vaping. The possible values of the measure were 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.
Time frame: Baseline; Every week during the intervention
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