Real-time eCounselling for Nicotine Addiction

Official title

Real-time eCounselling for Nicotine Addiction: a Feasibility Study and Pilot RCT

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Abstinence status [Time frame: 1 week post study: 7 days retrospective]
• Nicotine consumption (cigarettes, units) [Time frame: Baseline; 6 weeks after the intervention]
• Nicotine consumption (cigarettes, time) [Time frame: Baseline; 6 weeks after the intervention]
• Nicotine consumption (vape, units) [Time frame: Baseline; 6 weeks after the intervention]
• Nicotine consumption (vape, time) [Time frame: Baseline; 6 weeks after the intervention]

Secondary outcome measures (5)

• Dependence and Craving (CDS) [Time frame: Baseline; 6 weeks after the intervention]
• Dependence and Craving (EDS) [Time frame: Baseline; 6 weeks after the intervention]
• 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 [Time frame: Baseline; Every week during the intervention]
• Decisional balance [Time frame: Baseline; Every week during the intervention]

Eligibility criteria

Inclusion criteria

• 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
• Able to provide written informed consent to participate -

Exclusion criteria

• 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
• Individuals with a PHQ-9 score of ≥ 14 or a GAD-7 score of >12.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Key contact — Leicester

Publications

• 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

Identifiers

NCT: NCT06544057 · P-PF-03.24.0002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗