Neurofeedback & Alcohol Dependence

Study Overview
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Brief Summary
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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
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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).

Official Title
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Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Device: fMRI-based neurofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback training group<br>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. | Device: fMRI-based neurofeedback<br>* 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.<br>|
| No Intervention: Treatment-as-usual control group<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indices of drinking (continuous) - % days abstinent | Derived from the Timeline Followback Calendar. | 4 months after baseline assessment/first training | 
| Indices of drinking (continuous) - drinks per drinking day | Derived from the Timeline Followback Calendar. | 4 months after baseline assessment/first training | 
| Indices of drinking (continuous) - % days of 'heavy drinking' | Defined as 8 or more alcohol units per day/men or 6 or more units/women. Derived from the Timeline Followback Calendar. | 4 months after baseline assessment/first training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craving, Cue Reactivity, Neurofeedback