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A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol.
BMC Psychiatry ( IF 3.4 ) Pub Date : 2020-06-30 , DOI: 10.1186/s12888-020-02739-1
Angelina Isabella Mellentin 1, 2, 3 , Anette Søgaard Nielsen 1, 2 , Leonie Ascone 4 , Janina Wirtz 4 , Jerzy Samochowiec 5 , Jolanta Kucharska-Mazur 5 , Friedrich Schadow 4 , Zofia Lebiecka 5 , Tomasz Skoneczny 5 , Nicolai Mistarz 1, 2 , Thomas Bremer 4 , Simone Kühn 4, 6, 7
Affiliation  

The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP. The study will be implemented as a randomized controlled trial. A total of 204consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP + treatment as usual (TAU); group B) stimuli-relevant AATP in virtual reality + TAU, and group C) TAU only (control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Repeated-measures ANOVA will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to group C and that group B will achieve better outcomes than group A. This study is the first trial examining the effectiveness of stimuli-relevant AATP delivered in a VR environment. The use of VR has shown promise in enhancing the effectiveness of other psychological treatments and since AATP has already been shown effective as add-on treatment, it is of interest to investigate whether these effects can be further enhanced by implementing the program in more ecologically valid environments. If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment. ClinicalTrials.gov ID: NCT04283305 Registration date: 24.02.20

中文翻译:

基于虚拟现实的避免酒精使用障碍的训练方法的随机对照试验:一项研究方案。

避免进近训练计划(AATP)已显示出初步的希望,可作为酒精依赖标准治疗的补充。但是,缺乏关于在典型的饮酒情况下进行AATP能否进一步增强疗效的知识。这项研究的主要目的是研究在虚拟现实酒吧环境中实施的方法避免训练是否优于AATP的经典操纵杆PC版本。该研究将作为随机对照试验进行。从标准的酒精治疗开始,将从德国,波兰和丹麦的酒精住院患者诊所招募的总共204例连续登记的酒精使用障碍(AUD)患者随机分为三组之一:A组)与刺激有关的AATP +治疗像往常一样(TAU);B组)虚拟现实+ TAU中与刺激相关的AATP,C组)仅TAU(对照组)。治疗结果将在治疗前,治疗后和3个月的随访中进行评估。重复测量方差分析将用于比较各组随时间推移的饮酒,渴望和冲动结果的轨迹。假设两个实验组将比C组获得更好的治疗结果,而B组将比A组获得更好的治疗效果。这项研究是第一项研究VR环境中与刺激有关的AATP有效性的试验。VR的使用已显示出增强其他心理治疗效果的希望,并且由于AATP已被证明可以有效地作为附加治疗,有兴趣研究是否可以通过在更生态有效的环境中实施该计划来进一步增强这些影响。如果证明有效,则AATP-VR可以像AATP一样容易且廉价地作为附加治疗或持续护理来实施,以增强当前循证治疗的有效性。ClinicalTrials.gov ID:NCT04283305注册日期:24.02.20
更新日期:2020-06-30
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