Detecting change in psychiatric functioning in clinical trials for cocaine use disorder: sensitivity of the Addiction Severity Index and Brief Symptom Inventory.

Detecting change in psychiatric functioning in clinical trials for cocaine use disorder: sensitivity of the Addiction Severity Index and Brief Symptom Inventory.
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DOI:
10.1016/j.drugalcdep.2021.109070
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发表时间:
2021-11-01
影响因子:
4.2
通讯作者:
Carroll KM
Carroll KM
中科院分区:
医学2区
文献类型:
--
作者:
Kiluk BD;Roos CR;Aslan M;Gueorguieva R;Nich C;Babuscio TA;Carroll KM

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临床试验中常用的评估工具来衡量药物使用者的功能结果,可能缺乏敏感性来检测治疗期间的变化,这可能限制了关于减少药物使用的好处的发现。这项研究评估了成瘾严重指数(ASI)在检测可卡因使用者精神功能变化方面的敏感性。数据汇集在可卡因使用障碍的五个临床试验(N=492)中,包括12周的治疗期和6个月的随访。采用内部Cohen‘s d’法评估改变对简明症状问卷的ASI精神病学综合评分(ASI-Squch)和全球严重性指数(GSI)以及可卡因使用的影响大小。从基线到12周(GSI d‘=0.59;ASI-心理d’=0.16)和6个月的随访(GSI d‘=0.48;ASI-心理d’=0.10),GSI的疗效大小大于ASI-智力。在基线(n=252)有非零ASI-精神病的患者中,在12周期间(d‘=0.53)和6个月随访(d’=0.47)中发现了中等效应。在两个样本中,可卡因使用天数变化的效应大小与GSI最相似。ASI精神病学综合评分在检测减少可卡因使用的临床试验参与者的精神功能变化方面的敏感性可能有限。它可能有助于检测那些在治疗开始时报告一些精神问题的人的变化。在评估减少可卡因使用的潜在功能益处时,未来的研究应该考虑一种仪器对变化的敏感性。
Assessment instruments commonly used in clinical trials to measure functional outcomes in substance users may lack sensitivity to detect change during treatment, potentially limiting findings regarding benefits of reduced drug use. This study evaluated the sensitivity of the Addiction Severity Index (ASI) to detect change in psychiatric functioning among cocaine users. Data were pooled across five clinical trials for cocaine use disorder (N = 492) that included a 12-week treatment period and 6-month follow-up. Within-person cohen’s d′ was used to evaluate effect size of change on the Psychiatric Composite Score of the ASI (ASI-Psych) and Global Severity Index (GSI) of the Brief Symptom Inventory, as well as cocaine use. Effect sizes were larger for GSI than ASI-Psych from baseline to week 12 (GSI d′ = 0.59; ASI-Psych d′ = 0.16), and 6-month follow-up (GSI d′ = 0.48; ASI-Psych d′ = 0.10). For those with non-zero ASI-Psych at baseline (n = 252), medium effect sizes were found over the 12-week period (d′ = 0.53) and 6-month follow-up (d′ = 0.47). Effect sizes for change in days of cocaine use were most similar to GSI in either sample. The ASI Psychiatric Composite Score may have limited sensitivity to detect change in psychiatric functioning among clinical trial participants who reduce cocaine use. It may be useful for detecting change amongst those reporting some psychiatric problems at the start of treatment. Future research should consider an instrument’s sensitivity to change when assessing the potential functional benefits of reducing cocaine use.
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