Comparing the 26 Week Efficacy of Allen Carr's Easyway to Stop Smoking and NHS 1-1 Counselling Provision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 620
- 试验地点
- 2
- 主要终点
- Cessation of smoking
研究概览
简要总结
The proposed study will compare the efficacy of two psychological stop smoking interventions.
详细描述
The proposed study comprises a randomised controlled trial (n = 620) which will compare the efficacy of two psychological stop smoking interventions. Specifically, Allen Carr's Easyway smoking cessation programme comprising one 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them) and a 1-1 counselling service available via the NHS (comprising one 30 minute session and four weekly follow ups of 10-15 minutes) will be compared. The efficacy of both treatments will be followed up at 4, 12 and 26 weeks after treatment. The evaluation will be compliant with the Russell 6 Standard (which requires, amongst other things, a double blind, randomised design, chemical verification of quit outcomes, and the inclusion of all participants who received treatment in the final analysis). The findings will add to the evidence base around the use of the Allen Carr method, in particular by testing it in non-commercial settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, 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
- 否
入选标准
- •Current smoker Aged over 18 Prepared to be assigned randomly to one of two treatment conditions (NHS standard provision or Allen Carr's Easyway) Intend to quit smoking cigarettes.
排除标准
- •Individuals who would prefer an NHS provided treatment Currently in another RCT or similar research project Have a mental health condition Are pregnant Have a respiratory disease (such as chronic obstructive pulmonary disease or emphysema).
- •Unable to reach the treatment locations (London South Bank Universities Southwark Campus or SW20) .
研究组 & 干预措施
NHS smoking cessation
NHS 1-1 smoking cessation programme. One thirty minute session followed by up to five shorter sessions (approx.10/15minutes) comprising Cognitive Behavioural Therapy/Motivational Interviewing to assist with smoking cessation.
干预措施: NHS 1-1 smoking cessation programme. (Behavioral)
Allen Carr's Easyway smoking cessation
Group smoking cessation programme. One 5/6 hour group session (plus one or two 3 hour booster sessions over the following 3 months for those who require them) comprising of Allen Carr's Easyway method being delivered in a spoken form.
干预措施: Group smoking cessation programme (Behavioral)
结局指标
主要结局
Cessation of smoking
时间窗: 26 weeks post treatment commencement
Measured in line with the Russell 6 standard (i.e. fewer than 5 incidents of smoking from the quit date, including all participants lost to follow-up as failed treatment, and confirming all successful quits via breath carbon monoxide testing). The intention to treat principle will be followed, and those lost to follow-up will be considered failed quit.
次要结局
- Self-reported maintenance of smoking cessation questions(4, 12, 26 weeks post treatment commencement)
- The Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985).(Baseline and 4, 12, 26 weeks post treatment commencement)
- Survey assessing use of Nicotine replacement therapy/nicotine containing products(4, 12, 26 weeks post treatment commencement)
- Quit efficacy questionnaire(Baseline, 4, 12, 26 weeks post treatment commencement)
- Perceived value of being nicotine free - Questionnaire(4, 12, 26 weeks post treatment commencement)