A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator.

A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator.
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用于治疗成人物质使用的相关药物:使用心理教育比较器进行随机对照试验的方案。

DOI:
10.1016/j.cct.2023.107125
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发表时间:
2023
影响因子:
2.2
通讯作者:
Robinson,Athena
Robinson,Athena
中科院分区:
医学4区
文献类型:
--
作者:
Prochaska,JudithJ;Vogel,ErinA;Chieng,Amy;Baiocchi,Michael;Pajarito,Sarah;Pirner,Maddison;Darcy,Alison;Robinson,Athena

文献摘要

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背景物质使用障碍(SUD)很普遍,危害健康和福祉。可扩展的解决方案,如数字治疗,可以提供一种基于人群的策略来解决SUD。两项形成性研究支持关系代理Woebot的可行性和可接受性,Woebot是一种基于动画屏幕的社交机器人,用于治疗成年人的肥皂水(W-Sud)。与等待名单对照相比,随机服用W-SODS的参与者从基线到治疗结束(EOT)的药物使用次数减少。目的为了进一步发展证据基础,当前的随机试验将随访延长至治疗后1个月,并将测试W-SUDS相对于心理教育对照的有效性。方法本研究将招募、筛选并同意400名在线报告有问题的药物使用的成年人。在基线评估之后,参与者将被随机分为8周的W-SODS或心理教育对照组。评估将在第4周、第8周(EOT)和第12周(治疗后1个月)进行。主要结果是过去一个月的药物使用次数,所有物质的总和。次要结果是大量饮酒的天数、戒除所有物质的天数、药物使用问题、禁欲的想法、渴望、抵抗药物使用的信心、抑郁和焦虑的症状以及工作效率。如果发现显著的组间差异,我们将探索治疗效果的调节因素和中介因素。结论目前的研究建立在新出现的证据的基础上,即数字治疗通过检查持续效果和对照心理教育控制条件的测试来减少问题物质的使用。如果有效,这些发现将对减少问题物质使用的可扩展移动卫生干预措施产生影响。试验登记:NCT04925570
BackgroundSubstance use disorders (SUDs) are prevalent and compromise health and wellbeing. Scalable solutions, such as digital therapeutics, may offer a population-based strategy for addressing SUDs. Two formative studies supported the feasibility and acceptability of the relational agent Woebot, an animated screen-based social robot, for treating SUDs (W-SUDs) in adults. Participants randomized to W-SUDs reduced their substance use occasions from baseline to end-of-treatment (EOT) relative to a waitlist control.ObjectiveTo further develop the evidence base, the current randomized trial extends follow-up to 1-month post-treatment and will test the efficacy of W-SUDs relative to a psychoeducational control.MethodsThis study will recruit, screen, and consent 400 adults online reporting problematic substance use. Following baseline assessment, participants will be randomized to 8 weeks of W-SUDs or a psychoeducational control. Assessments will be conducted at weeks 4, 8 (EOT), and 12 (1-month post-treatment). Primary outcome is past-month number of substance use occasions, summed across all substances. Secondary outcomes are number of heavy drinking days, the percent of days abstinent from all substances, substance use problems, thoughts about abstinence, cravings, confidence to resist substance use, symptoms of depression and anxiety, and work productivity. If significant group differences are found, we will explore moderators and mediators of treatment effects.ConclusionsThe current study builds upon emerging evidence of a digital therapeutic for reducing problematic substance use by examining sustained effects and testing against a psychoeducational control condition. If efficacious, the findings have implications for scalable mobile health interventions for reducing problematic substance use.Trial Registration:NCT04925570