Clinical trial NCT06544057: Real-time eCounselling for Nicotine Addiction
Official title: Real-time eCounselling for Nicotine Addiction: a Feasibility Study and Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Use Disorder
Keywords: Smoking cessation
Vaping
Public health
eHealth
Nicotine addiction
Feasibility
Lead sponsor: Overcome
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a two-arm Block randomised pilot trial with study centres using block randomisation comparing Wait-list and Active.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Abstinence status
timeFrame: 1 week post study: 7 days retrospective
measure: Nicotine consumption (cigarettes, units)
timeFrame: Baseline; 6 weeks after the intervention
measure: Nicotine consumption (cigarettes, time)
timeFrame: Baseline; 6 weeks after the intervention
measure: Nicotine consumption (vape, units)
timeFrame: Baseline; 6 weeks after the intervention
measure: Nicotine consumption (vape, time)
timeFrame: Baseline; 6 weeks after the intervention
Secondary outcomes:
measure: Dependence and Craving (CDS)
timeFrame: Baseline; 6 weeks after the intervention
measure: Dependence and Craving (EDS)
timeFrame: Baseline; 6 weeks after the intervention
measure: Readiness to Quit
timeFrame: Baseline; Every week during the intervention
measure: Perceived Smoking Abstinence Efficacy as assessed by questionnaire measuring participants' confidence in their ability to quit smoking, and their resistance to temptation to relapse
timeFrame: Baseline; Every week during the intervention
measure: Decisional balance
timeFrame: Baseline; Every week during the intervention
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Key contact
state: Midlands
Study officials:
affiliation: Overcome
name: Helen Hayward, BSc
role: STUDY_DIRECTOR
References:
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citation: 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.