Real-time eCounselling for Nicotine Addiction

Overcome

Status: Enrolling

Conditions: Nicotine Use Disorder

Treatments: Behavioral: CBT-MI

Study type: Interventional

Funder types: Other

Identifiers

NCT06544057

P-PF-03.24.0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

CBT-MI

Experimental group

Description:

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.

Treatment:

Behavioral: CBT-MI

Wait-list

No Intervention group

Description:

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