An Efficacy Study Using an Established Cognitive Behavioral Therapy Manual for Smoking Cessation Comparing the Benefit of Virtual Reality Cue Exposure to a Specific Stress Reduction Protocol for Relapse Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 3
- 主要终点
- Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment
研究概览
简要总结
Cognitive-behavioral therapy (CBT) combined with medication is an established intervention for smoking cessation. However, long-term abstinence rates of maximum 35% are yielded. Moreover, acceptance of drug treatment is partly very low. Professional recommendation of drug treatment besides nicotine-replacement aids is restrained considering side effects and contraindications. Currently, cue exposure is highly discussed as intervention for craving reduction supporting CBT. There is evidence for benefits of cue exposure optimizing smoking cessation outcomes, as well as evidence for efficacy of exposure in virtual reality (VR) up to date.
However, this is the first randomized controlled study focusing on efficacy increases by VR cue exposure supporting an established CBT smoking cessation manual. The control group receives a specific stress reduction treatment (independent of smoking cues), namely, the Progressive Muscle Relaxation (PMR, according to Jacobson) additionally to the established smoking cessation CBT.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •daily smokers for at least 2 years, smoking minimum 10 cigarettes a day
排除标准
- •pregnancy
- •current participation in another smoking cessation program within 6 months before assignment
- •current diagnosis of a psychiatric disease including a depression or substance use disorder (excluding nicotine dependency)
- •lifetime diagnosis of a psychiatric disease : psychosis, bipolar affective disorder, posttraumatic stress disorder, conversion disorder.
结局指标
主要结局
Continuous (self-reported) abstinence rates from smoking 6 months after end of treatment
时间窗: at the 6 month follow-up
6-month continuous smoking abstinence according to the Russell Standard (West et al., 2005): no cigarette smoking assessed by self-report (number of smoked cigarettes) and a negative biochemical validation (CO measurement below 9) at the final follow-up. 6-month continuous smoking abstinence ordinal scale: 0=no abstinence, 1= either subjective or biochemical validation depicts no abstinence, 2= biochemical validated abstinence at the 6 months follow-up.
次要结局
- Changes in heartbeat-evoked potential during smoking cue exposure(Differences from baseline to the 6 month follow-up)
- Subjective ratings on the smoking self-efficacy scale(Differences from baseline to the 6 month follow-up)
- Number of daily smoked cigarettes after smoking cessation(Time Frame: Differences from smoking cessation to the 6 month follow-up)
- Changes in smoking cue event-related potentials (ERP: LPP)(Differences from baseline to the 6 month follow-up)
- Changes in smoking cue event-related potentials (ERP:P3)(Differences from baseline to the 6 month follow-up)
- Changes in approach tendency to smoking pictures(Differences from baseline to the 6 month follow-up)
- Changes in Theta and Alpha band power during smoking cue exposure(Differences from baseline to the 6 month follow-up)
- Changes in smoking cue reactivity related skin conductance level(Differences from baseline to the 6 month follow-up)
研究者
Anil Batra
Deputy Head of Psychiatry
University Hospital Tuebingen