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临床试验/NCT02567097
NCT02567097已完成不适用

The Role of Self-Incentives in Smoking Cessation: A Randomised Controlled Trial Within a Local Prison

University of Manchester2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Smoking status

研究概览

简要总结

Tobacco use is the greatest cause of ill health and early mortality, and smoking is the main contributor to around 75,000 deaths a year in England. The aim of the present research is to test the effect of helping people to reward themselves when they have successfully abstained from smoking and the impact this will have on subsequent smoking cessation. Each participant will be randomly allocated to one of four conditions. The trial requires 159 participants to perform an fully powered statistical analysis. The four conditions include: (1) a control condition (asked to form a plan to quit smoking), (2) an implementation intention condition (asked to form a more specific 'if-then' plan), (3) baseline which include: (1) a control condition (asked to form a plan to quit smoking), (2) a volitional help sheet condition (asked to link temptations with appropriate behavioural responses), (3) a weekly self-incentivising condition (asked to reward themselves at the end of each week that they have successfully abstained from smoking), or (4) a monthly self-incentivising condition (asked to reward themselves at the end of each month that they have successfully abstained from smoking). The main outcome measure will be smoking quit status, which will be verified biochemically at the end of the stop smoking programme, and at six-months post quit date.

详细描述

The research aims to test the role of self-incentivising implementation intentions in smoking cessation among prisoners aged 18 and over, enrolling on a stop smoking programme provided by Livewire within Risley Prison. The effectiveness of self-incentives has been successfully seen previously within health behaviour change, but not within smoking cessation (ongoing randomised controlled trial in alongside community stop smoking services, and local workplaces). This research will build on this by testing the effectiveness of self-incentives in prisoners' stop smoking attempts.

This study is a randomised controlled trial with the between participants factor of condition which has four levels:

  1. Control (plan) 2 Self-generated implementation intention (if-then plan) 3. Weekly self-incentivising implementation intention 4. Monthly self-incentivising implementation intention

The within participants' factor will be time which has three levels:

  1. Baseline (T1)
  2. Follow-up (T2) (end of stop smoking programme)
  3. Follow-up (T3) (six months post quit date)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 or over
  • Able to understand verbal English
  • Competent to provide informed consent
  • Attending or previously attended the stop smoking services provided

排除标准

  • Not aged 18 or over
  • Not able to understand verbal English
  • Not competent to provide informed consent
  • Not attending or previously attended the stop smoking services provided

结局指标

主要结局

Smoking status

时间窗: up to 6-months

次要结局

  • Amount of cigarettes smoked at both followup time periods(up to 6-months)
  • Frequency of self-incentivisation(up to 6-months)
  • Self-incentives used(up to 6-months)
  • Self-regulation strategies used(up to 6-months)
  • Source of motivation to quit smoking(up to 6-months)
  • Compliance to self-incentivise(up to 6-months)
  • Smoking behaviour (habitual)(up to 6-months)
  • Intentions to stop smoking(up to 6-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Armitage

Professor Christopher Armitage

University of Manchester

研究点 (2)

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