TY - JOUR

T1 - Neurofeedback training for alcohol dependence versus treatment as usual

T2 - Study protocol for a randomized controlled trial

AU - Cox, William

AU - Subramanian, Leena

AU - Linden, David E.J.

AU - Lührs, Michael

AU - McNamara, Rachel

AU - Playle, Rebecca

AU - Hood, Kerenza

AU - Watson, Gareth

AU - Whittaker, Joseph R.

AU - Sakhuja, Raman

AU - Ihssen, Niklas

N1 - The “Real-Time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence” trial is funded by the European Commission 7th Framework Programme for Research, Technological Development and Demonstration, and is a component of Work Package 4 of the BRAINTRAIN Consortium (Project 602186). The South East Wales Trials Unit is funded by Health and Care Research Wales.

PY - 2016/10/3

Y1 - 2016/10/3

N2 - Background: Real-time functional magnetic resonance imaging (rtfMRI) is used for neurofeedback training (NFT).Preliminary results suggest that it can help patients to control their symptoms. This study uses rtfMRI NFT forrelapse prevention in alcohol dependence.Methods/design: Participants are alcohol-dependent patients who have completed a detoxification programmewithin the past 6 months and have remained abstinent. Potential participants are screened for eligibility, and thosewho are eligible are randomly assigned to the treatment group (receiving rtfMRI NFT in addition to treatment asusual) or the control group (receiving only treatment as usual). Participants in both groups are administeredbaseline assessments to measure their alcohol consumption and severity of dependence and a variety ofpsychological and behavioural characteristics that are hypothesised to predict success with rtfMRI NFT. During thefollowing 4 months, experimental participants are given six NFT sessions, and before and after each session variousalcohol-related measures are taken. Participants in the control group are given the same measures to coincide withtheir timing in the experimental group. Eight and 12 months after the baseline assessment, both groups arefollowed up with a battery of measures. The primary research questions are whether NFT can be used to teachparticipants to down-regulate their brain activation in the presence of alcohol stimuli or to up-regulate their brainactivation in response to pictures related to healthy goal pursuits, and, if so, whether this translates into reductionsin alcohol consumption. The primary outcome measures will be those derived from the functional brain imagingdata. We are interested in improvements (i.e., reductions) in participants’ alcohol consumption from pretreatmentlevels, as indicated by three continuous variables, not simply whether or not the person has remained abstinent.The indices of interest are percentage of days abstinent, drinks per drinking day, and percentage of days of heavydrinking. General linear models will be used to compare the NFT group and the control group on these measures.Discussion: Relapse in alcohol dependence is a recurring problem, and the present evaluation of the role of rtfMRIin its treatment holds promise for identifying a way to prevent relapse.

AB - Background: Real-time functional magnetic resonance imaging (rtfMRI) is used for neurofeedback training (NFT).Preliminary results suggest that it can help patients to control their symptoms. This study uses rtfMRI NFT forrelapse prevention in alcohol dependence.Methods/design: Participants are alcohol-dependent patients who have completed a detoxification programmewithin the past 6 months and have remained abstinent. Potential participants are screened for eligibility, and thosewho are eligible are randomly assigned to the treatment group (receiving rtfMRI NFT in addition to treatment asusual) or the control group (receiving only treatment as usual). Participants in both groups are administeredbaseline assessments to measure their alcohol consumption and severity of dependence and a variety ofpsychological and behavioural characteristics that are hypothesised to predict success with rtfMRI NFT. During thefollowing 4 months, experimental participants are given six NFT sessions, and before and after each session variousalcohol-related measures are taken. Participants in the control group are given the same measures to coincide withtheir timing in the experimental group. Eight and 12 months after the baseline assessment, both groups arefollowed up with a battery of measures. The primary research questions are whether NFT can be used to teachparticipants to down-regulate their brain activation in the presence of alcohol stimuli or to up-regulate their brainactivation in response to pictures related to healthy goal pursuits, and, if so, whether this translates into reductionsin alcohol consumption. The primary outcome measures will be those derived from the functional brain imagingdata. We are interested in improvements (i.e., reductions) in participants’ alcohol consumption from pretreatmentlevels, as indicated by three continuous variables, not simply whether or not the person has remained abstinent.The indices of interest are percentage of days abstinent, drinks per drinking day, and percentage of days of heavydrinking. General linear models will be used to compare the NFT group and the control group on these measures.Discussion: Relapse in alcohol dependence is a recurring problem, and the present evaluation of the role of rtfMRIin its treatment holds promise for identifying a way to prevent relapse.

U2 - 10.1186/s13063-016-1607-7

DO - 10.1186/s13063-016-1607-7

M3 - Article

VL - 2016

SP - 480

JO - Trials

JF - Trials

SN - 1745-6215

IS - 17

ER -