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Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder
BACKGROUND: Alcohol use disorder (AUD) leads to a significant individual and societal burden. To achieve higher therapy success rates, therapeutic interventions still need to be improved. Most current neuroscientific conceptualizations of AUD focus on the imbalance between an enhanced automatic reac...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612135/ https://www.ncbi.nlm.nih.gov/pubmed/31277683 http://dx.doi.org/10.1186/s13063-019-3505-2 |
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author | Tschuemperlin, Raphaela M. Stein, Maria Batschelet, Hallie M. Moggi, Franz Soravia, Leila M. |
author_facet | Tschuemperlin, Raphaela M. Stein, Maria Batschelet, Hallie M. Moggi, Franz Soravia, Leila M. |
author_sort | Tschuemperlin, Raphaela M. |
collection | PubMed |
description | BACKGROUND: Alcohol use disorder (AUD) leads to a significant individual and societal burden. To achieve higher therapy success rates, therapeutic interventions still need to be improved. Most current neuroscientific conceptualizations of AUD focus on the imbalance between an enhanced automatic reaction to alcohol cues and impaired inhibition. Complementary to traditional relapse prevention strategies, novel computerized training interventions aim to directly alter these processes. This study tests a computerized alcohol-specific inhibition training in a large clinical sample and investigates its effects on behavioral, experimental and neurophysiological outcomes. It also analyzes whether variations in inhibition difficulty and/or endogenous cortisol levels during training impact these effects. METHODS: This is a double-blind, randomized controlled trial (RCT) with 246 inpatients with AUD participating. After baseline assessment, participants are randomly assigned to one of three computerized Go-NoGo-based inhibition training interventions (two alcohol-specific versions with different Go/NoGo ratios, or neutral control training) and one of two intervention times (morning/afternoon), resulting in six study arms. All patients perform six training sessions within 2 weeks. Endogenous cortisol is measured in 80 patients before and after the first training session. Inhibitory control and implicit associations towards alcohol are assessed pre and post training, at which point electroencephalography (EEG) is additionally measured in 60 patients. Patients’ alcohol consumption and relevant psychological constructs (e.g., craving, self-efficacy, treatment motivation) are measured at discharge and at 3-, 6- and 12-month follow-ups. Fifty healthy participants are assessed (20 with EEG) at one time point as a healthy control group. DISCUSSION: This study investigates the effects of a computerized, alcohol-specific inhibition training for the first time in patients with AUD. Results should give insight into the effectiveness of this potential add-on to standard AUD treatment, including proximal and distal measures and effects on behavioral, experimental and neurophysiological measures. Information about working mechanisms and potential optimizations of this training are gathered through variations regarding difficulty of inhibition training and training time. This study may thus contribute to a deepened understanding of AUD and the improvement of its evidence-based treatment. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02968537. Registered on 18 November 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3505-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6612135 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-66121352019-07-16 Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder Tschuemperlin, Raphaela M. Stein, Maria Batschelet, Hallie M. Moggi, Franz Soravia, Leila M. Trials Study Protocol BACKGROUND: Alcohol use disorder (AUD) leads to a significant individual and societal burden. To achieve higher therapy success rates, therapeutic interventions still need to be improved. Most current neuroscientific conceptualizations of AUD focus on the imbalance between an enhanced automatic reaction to alcohol cues and impaired inhibition. Complementary to traditional relapse prevention strategies, novel computerized training interventions aim to directly alter these processes. This study tests a computerized alcohol-specific inhibition training in a large clinical sample and investigates its effects on behavioral, experimental and neurophysiological outcomes. It also analyzes whether variations in inhibition difficulty and/or endogenous cortisol levels during training impact these effects. METHODS: This is a double-blind, randomized controlled trial (RCT) with 246 inpatients with AUD participating. After baseline assessment, participants are randomly assigned to one of three computerized Go-NoGo-based inhibition training interventions (two alcohol-specific versions with different Go/NoGo ratios, or neutral control training) and one of two intervention times (morning/afternoon), resulting in six study arms. All patients perform six training sessions within 2 weeks. Endogenous cortisol is measured in 80 patients before and after the first training session. Inhibitory control and implicit associations towards alcohol are assessed pre and post training, at which point electroencephalography (EEG) is additionally measured in 60 patients. Patients’ alcohol consumption and relevant psychological constructs (e.g., craving, self-efficacy, treatment motivation) are measured at discharge and at 3-, 6- and 12-month follow-ups. Fifty healthy participants are assessed (20 with EEG) at one time point as a healthy control group. DISCUSSION: This study investigates the effects of a computerized, alcohol-specific inhibition training for the first time in patients with AUD. Results should give insight into the effectiveness of this potential add-on to standard AUD treatment, including proximal and distal measures and effects on behavioral, experimental and neurophysiological measures. Information about working mechanisms and potential optimizations of this training are gathered through variations regarding difficulty of inhibition training and training time. This study may thus contribute to a deepened understanding of AUD and the improvement of its evidence-based treatment. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02968537. Registered on 18 November 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3505-2) contains supplementary material, which is available to authorized users. BioMed Central 2019-07-05 /pmc/articles/PMC6612135/ /pubmed/31277683 http://dx.doi.org/10.1186/s13063-019-3505-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Tschuemperlin, Raphaela M. Stein, Maria Batschelet, Hallie M. Moggi, Franz Soravia, Leila M. Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder |
title | Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder |
title_full | Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder |
title_fullStr | Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder |
title_full_unstemmed | Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder |
title_short | Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder |
title_sort | learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612135/ https://www.ncbi.nlm.nih.gov/pubmed/31277683 http://dx.doi.org/10.1186/s13063-019-3505-2 |
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