Real-time eCounselling for Nicotine Addiction

NCT06544057 | Recruiting

• 1 other identifier: P-PF-03.24.0002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Use Disorder

Keywords

Smoking cessation; Vaping; Public health; eHealth; Nicotine addiction; Feasibility

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Dependence and Craving (CDS)

  Baseline; 6 weeks after the intervention

• Dependence and Craving (EDS)

  Baseline; 6 weeks after the intervention

• 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

  Baseline; Every week during the intervention

• Decisional balance

  Baseline; Every week during the intervention

Study Arms (2)

CBT-MI

EXPERIMENTAL

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

Wait-list

NO INTERVENTION

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

Interventions

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'

CBT-MI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Overcome: lead

Study Sites (1)

Key contact

Leicester, Midlands, LE67 2BF, United Kingdom

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Smoking

Study Officials

• Helen Hayward, BSc

  Overcome

  STUDY DIRECTOR

Central Study Contacts

Helen Hayward, BSc

CONTACT

447423967654; operations_manager@overcome.org.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The blinding procedure aims to minimise bias by ensuring the outcome assessor, a member of our research team, remains unaware of participants' treatment allocation (Intervention or WLCG). This 'Single-Blind' design involves blinding the internal team's outcome assessor, who evaluates study endpoints without knowledge of participants' group assignments. To uphold blinding integrity, outcome assessors refrain from engaging with participants or study personnel. Participants and intervention administrators are not blinded due to the intervention nature
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a two-arm Block randomised pilot trial with study centres using block randomisation comparing Wait-list and Active.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 9, 2024
• Study Start: July 8, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 30, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)