A Randomized Controlled Trial of Smoking Interventions in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Smoking Intentions
研究概览
简要总结
The study is a randomised controlled trial (RCT) designed to test two tailored conditions of an appearance-based intervention for smoking in female smokers, compared to a control group administered a general stop smoking intervention.
The intervention delivery is being tested to assess whether the level of physiological arousal evoked by the intervention and the instruction type has an influence on the outcome measures. To do this one condition will receive the intervention with a neutral instruction and the other the intervention with additional instructions, measures of physiological stress reactivity will be used to measure level of stress evoked by the intervention and delivery.
详细描述
Background
Despite health-related smoking cessation campaigns, still one in five of adults in the UK smokes and it is estimated that half of all regular smokers will eventually die from smoking-related diseases. Innovative smoking cessation campaigns are needed to reach the remaining smoker population and prevent smoking-related diseases.
Smoking interventions have previously focused on smoking impact on health. However, besides health-related diseases, smoking causes aging effects to the skin and recent research suggests that smoking interventions based on threats to appearance may be more effective. Further research using an age-appearance facial morphing intervention for smoking, which shows women realistic images of the effects of smoking on their own face, research found that female smokers aged 18-34 reported increased motivation to quit after the intervention. Quantitative results from a randomised control trial support the interventions effectiveness .
The previous research on appearance-based interventions for smoking show promising results however these studies had report small sample sizes and differences in the age range of participants. Additionally, previous research has focused on the primary outcome measures of smoking including smoking cognitions, behaviours and CO readings and have not investigated further moderating variables such as, anxiety, depression, appearance orientation and stage of change.
In previous research participants have consistently reported a 'shock' reaction, and findings from a pilot and feasibility study (unpublished) suggest that this 'shock' reaction as measured by physiological reactivity to the intervention could mediate smoking outcomes. Therefore, the present research proposes to assess facial morphing intervention effectiveness in relation to individual's physiological shock reactions to viewing the morphed images and moderator variables in a large sample of women across a broad age range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will receive a brief description of both the appearance-based intervention and general stop smoking intervention. Participants will not know prior to taking part which condition they will be randomised into, on completion of the intervention it will become apparent whether they received the appearance-based intervention or general intervention. For participants randomised to the appearance intervention the instruction type will remain concealed. The investigator will not be blind throughout.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-55
- •Smoke at least 1 cigarette a week
排除标准
- •Non-smokers
- •Self-reported appearance related mental health issue
结局指标
主要结局
Change in Smoking Intentions
时间窗: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
Smoking Intentions, which are intentions the participant has to quit smoking are measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. The score from each individual item is then averaged together to create a total score for smoking intentions. The higher the averaged score the more intention the participant has to quit smoking.The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
次要结局
- Change in Smoking Subjective Norms(Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.)
- Change in Smoking Attitudes(Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.)
- Change in Smoking Perceived Behavioural Control(Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.)
- Change in Nicotine dependence(Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.)
- Change in Self-reported smoking behaviour(Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.)
研究者
Lucy Walker
Prinical Investigator
Manchester Metropolitan University