Increasing the Smoking Cessation Success Rate by Enhancing Improvement of Self-control Through Sleep-amplified Memory Consolidation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Percentage of abstinent days
研究概览
简要总结
The goal of this subproject is to examine the hypothesized improvement of treatment with chess-based training and sleep enhancement, both together and on their own, in smokers.
Participants will undergo fMRI measurements, sleep monitoring. They will then be assigned to one of the four experimental groups, including high-intensity interval training with or without chess-based training.
详细描述
This subproject aims to improve treatment outcome in patients with tobacco use disorder (TUD) by enhancing cognitive control. Evidence from the first funding period (1st FP) indicates that enhancing cognitive control using cognitive remediation training (CRT, in our case chess-based) can improve outcomes of a standard smoking cessation program. The current project will harness three means to build on this success of enhancing cognitive control by: 1. using our tried-and-tested chess-based training, 2. improving sleep using high-intensity interval training (HIIT), 3. increasing sleep-dependent consolidation of the chess-based training (see Figure 1). We hypothesize that chess-based training and sleep enhance treatment outcome, both together and on their own. To test our hypotheses, we will combine smoking cessation treatment with the aforementioned approaches as app-based add-ons (chess-based training and HIIT). This will not only allow us to apply the training in a cost-efficient way out-side the lab, it may also increase patients' compliance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe tobacco use disorder (TUD) according to DSM-5
- •sufficient ability to communicate with investigators and answer questions in both written and verbal format
- •ability to provide fully informed consent and to use self-rating scales
- •right-handedness
- •HIIT can be performed without the risk of side effect (medical sports check)
排除标准
- •severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
- •history of brain injury
- •severe physical diseases
- •common exclusion criteria for MRI (e.g. metal, claustrophobia)
- •positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
- •psychotropic medication within the last 14 days
- •pregnancy
研究组 & 干预措施
HIIT morning
High-intensity interval training (HIIT) in the morning
干预措施: Standard smoking cessation program (SCP) (Behavioral)
HIIT evening
High-intensity interval training (HIIT) in the evening
干预措施: Standard smoking cessation program (SCP) (Behavioral)
HIIT evening
High-intensity interval training (HIIT) in the evening
干预措施: High-intensity interval training (HIIT evening) (Behavioral)
HIIT morning + CRT
High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)
干预措施: Standard smoking cessation program (SCP) (Behavioral)
HIIT morning + CRT
High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)
干预措施: Cognitive remediation treatment (CRT) (Behavioral)
HIIT evening + CRT
High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)
干预措施: Standard smoking cessation program (SCP) (Behavioral)
HIIT evening + CRT
High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)
干预措施: Cognitive remediation treatment (CRT) (Behavioral)
HIIT evening + CRT
High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)
干预措施: High-intensity interval training (HIIT evening) (Behavioral)
结局指标
主要结局
Percentage of abstinent days
时间窗: timepoint 3: follow-up 3 months after end of SCP
Percentage of abstinent days in the 3 months after treatment
Change in neural measures of response inhibition
时间窗: 2 time points: before and after 6 weeks SCP
SST fMRI task (Gan et al., 2014)
Change in neural functional connectivity in the salience network
时间窗: 2 time points: before and after 6 weeks SCP
resting state connectivity to seed region right anterior insula
Time until first severe relapse
时间窗: timepoint 3: follow-up 3 months after end of SCP
days until the first severe smoking relapse after treatment
Change in neural measures of working memory
时间窗: 2 time points: before and after 6 weeks SCP
Nback fMRI task (Charlet et al., 2014)
Change in smoking urges
时间窗: 2 time points: before and after 6 weeks SCP
questionnaire of smoking urges (QSU, Müller et al. 2001)
次要结局
未报告次要终点