Real-time eCounselling for Nicotine Addiction: a Feasibility Study and Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Overcome
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Nicotine consumption (cigarettes, time)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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.
结局指标
主要结局
Nicotine consumption (cigarettes, time)
时间窗: Baseline; 6 weeks after the intervention
Time: Time spent smoking nicotine, on average, per day
Nicotine consumption (vape, time)
时间窗: Baseline; 6 weeks after the intervention
Time: Time spent vaping nicotine, on average, per day
Nicotine consumption (cigarettes, units)
时间窗: Baseline; 6 weeks after the intervention
Unit: Number of cigarettes consumed, on average, per day
Nicotine consumption (vape, units)
时间窗: Baseline; 6 weeks after the intervention
Unit: Number of 15-minute 'episodes' of vaping, on average, per day
Abstinence status
时间窗: 1 week post study: 7 days retrospective
This is a binary indicator, suggesting whether or not participants are abstinent at point of questioning
次要结局
- Dependence and Craving (EDS)(Baseline; 6 weeks after the intervention)
- Readiness to Quit(Baseline; Every week during the intervention)
- Dependence and Craving (CDS)(Baseline; 6 weeks after the intervention)
- Decisional balance(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)