Alcohol Dependence
Conditions
Keywords
Craving, Cue Reactivity, Neurofeedback
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).
Interventions
DEVICEfMRI-based neurofeedback
During scanning patients will be exposed to picture stimuli (showing alcoholic drinks and life goals) projected on a screen behind the scanner and viewed through a mirror attached on the MRI head coil. In each session patients will be trained to down-regulate/up-regulate activation levels in brain areas that show reliable responses to the alcohol/life goals pictures in a 'localiser' scan. Self-regulation of these brain responses will then be guided by real-time feedback of alcohol/life goals-cue elicited activation, consisting of changes in the visible alcohol/life goals picture (decreasing size = successful down-regulation; increasing size = successful upregulation). Functional MRI data will be acquired in short blocks having a duration of 5-8 minutes.
Sponsors
European Commission
Cardiff University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successful completion of detoxification programme within a time window of 1 to 6 months before the recruitment * Abstinence since detoxification treatment
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Drinking urges/craving assessed with the Drinking Urges Questionnaire (DUQ) | 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) |
| Hospital Anxiety and Depression Scale | 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 |
Countries
United Kingdom
Outcome results
None listed