Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Indices of drinking (continuous) - % days abstinent
研究概览
简要总结
The study aims to examine whether the neurofeedback method (based on functional magnetic resonance imaging [fMRI]) can help patients with alcohol dependence to control their urges to drink alcohol and thus to remain abstinent. Potential effects of neurofeedback on abstinence and drinking behaviour will be evaluated based on the comparison between a group of patients receiving multiple sessions of neurofeedback training and a group of patients receiving treatment as usual over the same period of time.
详细描述
Neurofeedback is a non-invasive neuroscientific tool in which participants receive real-time feedback about their brain activity while undergoing functional magnetic resonance imaging. Previous research has shown that participants can successfully use the feedback to self-regulate their brain responses. In this study patients who have successfully completed a detoxification programme will be trained to down-regulate/upregulate responses of motivational brain regions that are activated during exposure to alcohol/life goal-related stimuli (pictures of alcoholic drinks/life goals related). The investigators hypothesise that learning to self-regulate these neural responses will enable patients to better control craving responses to environmental alcohol cues after detoxification treatment. Patients in the intervention group will undergo 6 neurofeedback training sessions, spread across 4 months. Outcomes of the training will be compared with a group of patients who will not do the neurofeedback training but receive standard treatment (e.g. support groups and medication).
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
- 否
入选标准
- •Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment
- •Abstinence since detoxification treatment
排除标准
- •Ongoing regular abuse of illicit substances except cannabis
- •History of psychotic disorders not related to alcohol
- •Involvement in other interventional research in the past 6 months
- •MRI counter-indications, e.g. claustrophobia, pregnancy, active medical implants, passive implants deemed unsuitable, metallic dust in the eyes, certain types of metal prostheses, surgical clips, previous experience with metalworking without eye protection
研究组 & 干预措施
Neurofeedback training group
The neurofeedback group will perform 6 training sessions over a period of 4 months: 4 fortnightly sessions in the first two months will be followed by 2 monthly 'booster' sessions. Each session will include several behavioural assessments and fMRI-based neurofeedback training in an MRI scanner (1 h). The neurofeedback training phase will be be followed-up by two behavioural assessments 8 and 12 months after the first training.
干预措施: fMRI-based neurofeedback (Device)
Treatment-as-usual control group
The control group will receive treatment as usual (e.g. medication, counselling) but no neurofeedback training during the study period. Patients in the control group will be invited for four behavioural assessment sessions (baseline assessment, follow-up assessments 4/8/12 months after baseline).
结局指标
主要结局
Indices of drinking (continuous) - % days abstinent
时间窗: 4 months after baseline assessment/first training
Derived from the Timeline Followback Calendar.
Indices of drinking (continuous) - drinks per drinking day
时间窗: 4 months after baseline assessment/first training
Derived from the Timeline Followback Calendar.
Indices of drinking (continuous) - % days of 'heavy drinking'
时间窗: 4 months after baseline assessment/first training
Defined as 8 or more alcohol units per day/men or 6 or more units/women. Derived from the Timeline Followback Calendar.
次要结局
- Beck Depression Inventory(Assessed 4 months, 8 months and 12 months after baseline)
- Hospital Anxiety and Depression Scale(Assessed 4 months, 8 months and 12 months after baseline)
- NHS Resource Use Questionnaire(Assessed 4 months, 8 months and 12 months after baseline)
- Debriefing Questionnaire (neurofeedback group only)(Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session))
- Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ)(Assessed 4 months, 8 months and 12 months after baseline)
- Drinking urges/craving assessed with the Obsessive Compulsive Drinking Scale (OCDS)(Assessed 4 months, 8 months and 12 months after baseline)
- Drinking urges/craving (attentional bias) assessed with the alcohol stroop test(Assessed 4 months, 8 months and 12 months after baseline)
- Craving self-ratings during scanning (neurofeedback group only)(Assessed 2, 4, 6, 8, 12, 16 weeks after baseline (each training session))
- Profile of Mood States Questionnaire(Assessed 4 months, 8 months and 12 months after baseline)
研究者
David Linden
Professor of Translational Neuroscience
Cardiff University