Abstract
BackgroundAlcohol Use Disorder is a severe mental disorder affecting the individuals concerned, their family and friends and society as a whole. Despite its high prevalence, novel treatment options remain rather limited. Two innovative interventions used for treating severe disorders are the use of real-time functional magnetic resonance imaging neurofeedback that targets brain regions related to the disorder, and mindfulness-based treatments. In the context of the TRR SFB 265 C04 “Mindfulness-based relapse prevention as an addition to rtfMRI NFB intervention for patients with Alcohol Use Disorder (MiND)” study, both interventions will be combined to a state-of-the art intervention that will use mindfulness-based relapse prevention to improve the efficacy of a real-time neurofeedback intervention targeting the ventral striatum, which is a brain region centrally involved in cue-reactivity to alcohol-related stimuli.Methods/designAfter inclusion, N = 88 patients will be randomly assigned to one of four groups. Two of those groups will receive mindfulness-based relapse prevention. All groups will receive two fMRI sessions and three real-time neurofeedback sessions in a double-blind manner and will regulate either the ventral striatum or the auditory cortex as a control region. Two groups will additionally receive five sessions of mindfulness-based relapse prevention prior to the neurofeedback intervention. After the last fMRI session, the participants will be followed-up monthly for a period of 3 months for an assessment of the relapse rate and clinical effects of the intervention.DiscussionThe results of this study will give further insights into the efficacy of real-time functional magnetic resonance imaging neurofeedback interventions for the treatment of Alcohol Use Disorder. Additionally, the study will provide further insight on neurobiological changes in the brain caused by the neurofeedback intervention as well as by the mindfulness-based relapse prevention. The outcome might be useful to develop new treatment approaches targeting mechanisms of Alcohol Use Disorder with the goal to reduce relapse rates after discharge from the hospital.Trial registrationThis trial is pre-registered at clinicaltrials.gov (trial identifier: NCT04366505; WHO Universal Trial Number (UTN): U1111–1250-2964). Registered 30 March 2020, published 29 April 2020.
Highlights
Alcohol Use Disorder is a severe mental disorder affecting the individuals concerned, their family and friends and society as a whole
The study will provide further insight on neurobiological changes in the brain caused by the neurofeedback intervention as well as by the mindfulness-based relapse prevention
The increase of the ability to voluntarily modulate brain activation to alcohol cues after training in the ventral striatum (VS) serves as a secondary outcome, whereas craving measures such as the Alcohol Abstinence Self-Efficacy Scale [18] will be analyzed as a primary outcome
Summary
In this project we assess the efficacy of regulating cuereactivity by means of rtfMRI NFB in AUD patients and investigate the impact of MBRP on the NFB procedure and the clinical outcome. The innovation of this study is that it will be the first of its kind to combine therapeutic and neurobiological interventions in order to treat alcohol use disorder Another distinctive feature is the high degree of comparability between the various conditions that we assess. We chose the VS here because we want to target reward dependent cue-reactivity especially reached by our alcohol pictures and not a general habit process It is arguable whether one should use the same paradigm in male and female participants. In this study we will still continue assessing both sexes in order to include sex differences in our analysis, but likely our study will include a higher ratio of male participants due to the basic rate in our patient population Another point to discuss is that rtfMRI NFB can only be performed successfully by a proportion of people, but likely not by everyone.
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