Real-time eCounselling for Nicotine Addiction
ConditionNicotine Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOvercome
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18-65 Years old
Self Reported smoking ≥ 5 cigarettes per day, or regular vaper of > 0mg nicotine
Desire to quit nicotine consumption
Willing to set a quit date
Disqualifiers
Enrolled in another behavioural intervention programme
Pregnant, breastfeeding or planning to become pregnant.
Individuals currently experiencing a problematic relationship with alcohol or drugs
Documented Cognitive Impairment
Trial design
Design model
Parallel
Treatments tested in this trial
CBT-MI
BehavioralCBT-MI combines elements from Cognitive Behavioural Therapy and Motivational Interviewing in treating nicotine addiction, delivered remotely via Zoom by trained 'layperson coaches'
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: CBT-MIExperimental treatment 1 intervention
Group B: Wait-listNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Abstinence 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 retrospective2
Nicotine consumption (cigarettes, units)
Unit: Number of cigarettes consumed, on average, per day
Time frame
Baseline; 6 weeks after the intervention3
Nicotine consumption (cigarettes, time)
Time: Time spent smoking nicotine, on average, per day
Time frame
Baseline; 6 weeks after the intervention4
Nicotine consumption (vape, units)
Unit: Number of 15-minute 'episodes' of vaping, on average, per day
Time frame
Baseline; 6 weeks after the interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 Source ClinicalTrials.gov