Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial

Abstract

BackgroundReal-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 for relapse prevention in alcohol dependence.Methods/designParticipants are alcohol-dependent patients who have completed a detoxification programme within the past 6 months and have remained abstinent. Potential participants are screened for eligibility, and those who are eligible are randomly assigned to the treatment group (receiving rtfMRI NFT in addition to treatment as usual) or the control group (receiving only treatment as usual). Participants in both groups are administered baseline assessments to measure their alcohol consumption and severity of dependence and a variety of psychological and behavioural characteristics that are hypothesised to predict success with rtfMRI NFT. During the following 4 months, experimental participants are given six NFT sessions, and before and after each session various alcohol-related measures are taken. Participants in the control group are given the same measures to coincide with their timing in the experimental group. Eight and 12 months after the baseline assessment, both groups are followed up with a battery of measures. The primary research questions are whether NFT can be used to teach participants to down-regulate their brain activation in the presence of alcohol stimuli or to up-regulate their brain activation in response to pictures related to healthy goal pursuits, and, if so, whether this translates into reductions in alcohol consumption. The primary outcome measures will be those derived from the functional brain imaging data. We are interested in improvements (i.e., reductions) in participants’ alcohol consumption from pretreatment levels, 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 heavy drinking. General linear models will be used to compare the NFT group and the control group on these measures.DiscussionRelapse in alcohol dependence is a recurring problem, and the present evaluation of the role of rtfMRI in its treatment holds promise for identifying a way to prevent relapse.Trial registrationClinicalTrials.gov Identifier: NCT02486900, registered on 26 June 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1607-7) contains supplementary material, which is available to authorized users.

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“…These additional publishing formats include preregistration, where researchers document their methodology with a timestamp on a public platform such as the Open Science Framework before data acquisition starts (e.g., Mehler et al, 2017). An alternative approach is to publish trial protocols in dedicated journals, which may be undertaken in parallel to data acquisition (e.g., Cox et al, 2016). Moreover, the recently introduced publishing format Registered Reports includes an initial peer-review stage that can grant authors acceptance in principle for their work independent of the statistical outcome.…”

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“…Depending on the study design and assessments, the experimental group may engage in a number of neurofeedback runs. For example, in Cox et al (Cox et al, 2016), the experimental group engaged in six neurofeedback sessions across 4 months while the control group attended four behavioural assessment sessions.…”

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