Neurofeedback & Alcohol Dependence
- Conditions
- Alcohol Dependence
- Interventions
- Device: fMRI-based neurofeedback
- Registration Number
- NCT02486900
- Lead Sponsor
- Cardiff University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment
- Abstinence since detoxification treatment
- Ongoing regular abuse of illicit substances except cannabis
- History of psychotic disorders not related to alcohol
- IQ < 70
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neurofeedback training group fMRI-based neurofeedback 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.
- Primary Outcome Measures
Name Time Method Indices of drinking (continuous) - % days abstinent 4 months after baseline assessment/first training Derived from the Timeline Followback Calendar.
Indices of drinking (continuous) - drinks per drinking day 4 months after baseline assessment/first training Derived from the Timeline Followback Calendar.
Indices of drinking (continuous) - % days of 'heavy drinking' 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.
- Secondary Outcome Measures
Name Time Method 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 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)
Trial Locations
- Locations (1)
School of Medicine, Cardiff University
🇬🇧Cardiff, Wales, United Kingdom