Real-time eCounselling for Nicotine Addiction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nicotine Use Disorder
• Intervention / Treatment: Behavioral: CBT-MI

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helen Hayward, BSc; Phone Number: 447423967654; Email: operations_manager@overcome.org.uk

Study Locations

• United Kingdom
  • Midlands
    • Leicester, Midlands, United Kingdom, LE67 2BF
      • Recruiting
      • Key contact
      • Contact: Helen Hayward, BSc; Phone Number: 447423967654; Email: operations_manager@overcome.org.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT-MI; Behavioural Therapy (CBT) with Motivational Interviewing (MI) techniques. It comprises six individual sessions delivered via real-time video (Zoom) on mobile or computer platforms. Sessions last approximately 45 to 60 minutes each.	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'
No Intervention: Wait-list; Control group will undergo recruitment and screening and be assigned to a wait-list, to undergo the intervention after the active group. Data collection will continue as in the active arm, to compare with that collected in the active arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Overcome
• Investigators: Study Director: Helen Hayward, BSc, Overcome

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Nicotine Tob Res. 2020 Oct 29;22(11):2123. doi: 10.1093/ntr/ntz095.
• 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

Helpful Links

• Centers for Disease and Control Prevention. (2023). Economic facts about U.S. tobacco production and use.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Feasibility; Smoking cessation; eHealth; Nicotine addiction; Vaping; Public health
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Tobacco Use Disorder; Behavior, Addictive
• Other Study ID Numbers: P-PF-03.24.0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A member of the research team (HH) will regularly monitor the trial and its delivery to ensure ongoing study protocol compliance. In the event of deviations from the study protocol or unexpected events, the study team will promptly document and report such occurrences to the designated individuals and the Institutional Ethics review board, following the established reporting timelines. All study-related documentation, including data collection forms and interview transcripts, will be securely stored in password-protected electronic databases, adhering to data security and confidentiality guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No