Real-time eCounselling for 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.

• CBT-MI (Behavioral): CBT-MI combines elements from Cognitive Behavioural Therapy and Motivational Interviewing in treating nicotine addiction, delivered remotely via Zoom by trained 'layperson coaches'

Primary outcomes

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

Secondary outcomes

• Dependence and Craving (CDS) [Baseline; 6 weeks after the intervention]: 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.
• Dependence and Craving (EDS) [Baseline; 6 weeks after the intervention]: 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.
• Readiness to Quit [Baseline; Every week during the intervention]: 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.
• Perceived Smoking Abstinence Efficacy as assessed by questionnaire measuring participants' confidence in their ability to quit smoking, and their resistance to temptation to relapse [Baseline; Every week during the intervention]: 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.
• Decisional balance [Baseline; Every week during the intervention]: '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.

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

1. Age: 18-65 Years old
2. Self Reported smoking ≥ 5 cigarettes per day, or regular vaper of > 0mg nicotine
3. Desire to quit nicotine consumption
4. Willing to set a quit date
5. Able to provide written informed consent to participate -

Exclusion Criteria:

1. Enrolled in another behavioural intervention programme
2. Pregnant, breastfeeding or planning to become pregnant.
3. Individuals currently experiencing a problematic relationship with alcohol or drugs
4. Documented Cognitive Impairment
5. Individuals with a PHQ-9 score of ≥ 14 or a GAD-7 score of >12.

• Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360. PMID 1935872
• Etter JF, Le Houezec J, Perneger TV. A self-administered questionnaire to measure dependence on cigarettes: the cigarette dependence scale. Neuropsychopharmacology. 2003 Feb;28(2):359-70. doi: 10.1038/sj.npp.1300030. PMID 12589389
• Morean ME, Krishnan-Sarin S, Sussman S, Foulds J, Fishbein H, Grana R, O'Malley SS. Psychometric Evaluation of the E-cigarette Dependence Scale. Nicotine Tob Res. 2019 Oct 26;21(11):1556-1564. doi: 10.1093/ntr/ntx271. PMID 29301008
• Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38. PMID 10170434
• Abrams, D. B., Herzog, T. A., Emmons, K. M., Linnan, L., & Stages of Change Working Group. (2000). Predicting smoking cessation from intentions and plans: Does type of smoker matter? Health Psychology, 19(1S), 24-33. DOI: 10.1016/j.addicn.2023.100068.
• Fidancı, I., Sümer, H. C., & Fırat, S. (2017). The role of emotion regulation difficulties and smoking-related cognitions in understanding anxiety and smoking among treatment-seeking smokers. Journal of Cognitive Psychotherapy, 31(3), 227-240
• Velicer WF, Diclemente CC, Rossi JS, Prochaska JO. Relapse situations and self-efficacy: an integrative model. Addict Behav. 1990;15(3):271-83. doi: 10.1016/0306-4603(90)90070-e. PMID 2378287

• Informed Consent Form (PDF, 2024-07-11)

• Helen Hayward, BSc, Study director, Overcome