The Comparative Efficacy of Cognitive-Behavioral Therapy (CBT) and Hypnotherapy (HT) for Smoking Cessation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- 12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005)
研究概览
简要总结
Intensive cognitive-behaviour interventions (CBT) combined with pharmacotherapy for smoking cessation are well established and have been proved to be efficacious. Nevertheless, they yield only long-term abstinence rates about 35%. Considering the high interest of smokers in alternative medicine, the availability of a broad range of treatment methods, of which smokers choose an intervention according to their preferences, might contribute to improve treatment outcome. While hypnotherapy (HT) is an already widely promoted alternative method for aiding cessation, considerable methodological shortcomings of studies on this topic limit the interpretability of the results. In 2006, the German Academic Advisory Committee for Psychotherapy released new guidelines that included HT as an acceptable treatment for smoking cessation. The committee conceded, however, that conclusions concerning its efficacy are restricted due to the heterogeneity of findings. Hence, further well-designed studies are required to better test the efficacy of HT in comparison to accepted treatments. This randomised, controlled trial aims to compare the efficacy of CBT and HT for smoking cessation. Further, the influence of moderating variables will be investigated. It is hypothesized that 1) participants receiving CBT will evince higher abstinence rates than those receiving HT, 2) levels of nicotine dependence, self-efficacy and motivation to change will moderate the intervention effects and 3) participants with high levels of suggestibility will evince higher abstinence rates in the HT-intervention compared to participants with low levels of suggestibility. 220 adult healthy smokers will be randomized to receive either CBT or HT. Both programmes will be conducted in 6, weekly, 90-minute group sessions. Participants will be followed up at 1, 3, 6, 9 und 12 month post-treatment. Generalized estimating equation models will be conducted to analyse group differences on abstinence rates. The models will include the above mentioned moderator variables.
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)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years of age
- •smoking at least 10 cigarettes per day
- •smoking at least for the past two years
- •fluency in German language
- •willing and able to give written informed consent
排除标准
- •women: planned or current pregnancy or breast-feeding
- •participation in a smoking cessation program within the last 6 months
- •severe mental illness
结局指标
主要结局
12-months continuous smoking abstinence according to the Russell Standard (RS; West et al. 2005)
时间窗: 12-months follow-up
次要结局
- 7-day point-prevalence smoking abstinence rates at 6- and 12-months follow-up(12-months follow-up)
研究者
Anil Batra
Prof. Dr.
University Hospital Tuebingen
