Neurofeedback & Alcohol Dependence

Cardiff University

Status: Completed

Conditions: Alcohol Dependence

Treatments: Device: fMRI-based neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT02486900

BRAINTRAINAD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Neurofeedback training group

Experimental group

Description:

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.

Treatment:

Device: fMRI-based neurofeedback

Treatment-as-usual control group

No Intervention group

Description:

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).