Real-time eCounselling for Nicotine Addiction
NCT Number: NCT06544057
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nicotine Use Disorder
Interventions: BEHAVIORAL: CBT-MI
Sponsor: Overcome
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-08
Completion Date: 2024-11
Locations: Key contact, Leicester, Midlands, LE67 2BF, United Kingdom

Summary:
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.

Primary Outcome Measures: Abstinence status, This is a binary indicator, suggesting whether or not participants are abstinent at point of questioning, 1 week post study: 7 days retrospective|Nicotine consumption (cigarettes, units), Unit: Number of cigarettes consumed, on average, per day, Baseline; 6 weeks after the intervention|Nicotine consumption (cigarettes, time), Time: Time spent smoking nicotine, on average, per day, Baseline; 6 weeks after the intervention|Nicotine consumption (vape, units), Unit: Number of 15-minute 'episodes' of vaping, on average, per day, Baseline; 6 weeks after the intervention|Nicotine consumption (vape, time), Time: Time spent vaping nicotine, on average, per day, Baseline; 6 weeks after the intervention
Secondary Outcome Measures: 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., 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., 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., 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., 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., Baseline; Every week during the intervention