title: Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial.
abstract: 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 for relapse prevention in alcohol dependence.
  
  
  
  Participants 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.
  
  
  
  Relapse 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.
  
  
  
  ClinicalTrials.gov Identifier: NCT02486900 , registered on 26 June 2015.
authors.affiliation: Cardiff University School of Medicine, Hadyn Ellis Building, Maindy Road, Cathays, Cardiff, CF24 4HQ, UK. cox.miles@gmail.com.
authors.forename: W Miles
authors.identifier: 0000-0003-4115-3575
authors.initials: WM
authors.lastname: Cox
authors.affiliation: Cardiff University School of Medicine, Hadyn Ellis Building, Maindy Road, Cathays, Cardiff, CF24 4HQ, UK.|School of Psychology, Tower Building, Cardiff University, 70 Park Place, Cardiff, CF10 3AT, UK.
authors.forename: Leena
authors.initials: L
authors.lastname: Subramanian
authors.affiliation: Cardiff University School of Medicine, Hadyn Ellis Building, Maindy Road, Cathays, Cardiff, CF24 4HQ, UK.|School of Psychology, Tower Building, Cardiff University, 70 Park Place, Cardiff, CF10 3AT, UK.
authors.forename: David E J
authors.initials: DE
authors.lastname: Linden
authors.affiliation: Department of Cognitive Neuroscience, Maastricht University, Oxfordlaan 55, 6229, Maastricht, The Netherlands.
authors.forename: Michael
authors.initials: M
authors.lastname: Lührs
authors.affiliation: South East Wales Trials Unit (SEWTU), Centre for Trials Research, Cardiff University, College of Biomedical and Life Sciences, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XN, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: McNamara
authors.affiliation: South East Wales Trials Unit (SEWTU), Centre for Trials Research, Cardiff University, College of Biomedical and Life Sciences, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XN, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Playle
authors.affiliation: South East Wales Trials Unit (SEWTU), Centre for Trials Research, Cardiff University, College of Biomedical and Life Sciences, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XN, UK.
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
authors.affiliation: South East Wales Trials Unit (SEWTU), Centre for Trials Research, Cardiff University, College of Biomedical and Life Sciences, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XN, UK.
authors.forename: Gareth
authors.initials: G
authors.lastname: Watson
authors.affiliation: Cardiff University School of Medicine, Hadyn Ellis Building, Maindy Road, Cathays, Cardiff, CF24 4HQ, UK.|School of Psychology, Tower Building, Cardiff University, 70 Park Place, Cardiff, CF10 3AT, UK.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Whittaker
authors.affiliation: Cwm Taf University Health Board, Llwyn yr Eos Clinic, Main Road, Church Village, Cardiff, CF38 1RN, UK.
authors.forename: Raman
authors.initials: R
authors.lastname: Sakhuja
authors.affiliation: Department of Psychology, Wolfson Building, Durham University, Queen's Campus, Stockton-on-Tees, TS17 6BH, UK.
authors.forename: Niklas
authors.initials: N
authors.lastname: Ihssen
mesh_terms: D064829:Alcohol Abstinence; D000428:Alcohol Drinking / Q000503:physiopathology / Q000517:prevention & control* / Q000523:psychology; D000437:Alcoholism / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D001921:Brain / Q000000981:diagnostic imaging / Q000503:physiopathology*; D001931:Brain Mapping / Q000379:methods; D002985:Clinical Protocols; D005240:Feasibility Studies; D006801:Humans; D008279:Magnetic Resonance Imaging; D058765:Neurofeedback; D012008:Recurrence; D012107:Research Design; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014852:Wales
keywords: Alcohol dependence; Functional magnetic resonance imaging; Neurofeedback training; Randomised controlled trial; Relapse prevention