Jack, Joseph and Morton Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland, OH, USA.
Department of Psychology, School of Humanities and Social Sciences, Pennsylvania State University, The Behrend College, Erie, PA, USA.
Psychiatry Res. 2023 Aug;326:115254. doi: 10.1016/j.psychres.2023.115254. Epub 2023 May 16.
Treatment discontinuation during clinical trials in schizophrenia is a critical challenge, especially for longer-term interventions in the early course. This research explored predictors of treatment discontinuation in an outpatient early course schizophrenia sample (N = 102) during an 18-month multi-site trial of Cognitive Enhancement Therapy (n = 58) and Enriched Supportive Therapy (n = 44). Fifty-three (52%) participants discontinued, with no significant difference between the treatment groups in discontinuation rate. Univariate and multivariate binary logistic regression models explored differences in key demographic and cognitive and behavioral outcomes between participants who completed and discontinued treatment. Significant multivariate predictors of discontinuation included IQ (linear) and problem solving (curvilinear). The concave shape of the problem solving prediction demonstrated that initially as scores were increasing the probability of non-completion was increasing. However, after a score of 41 (below average problem solving), the probability of being a non-completer decreased as performance increased. Non-completers had significantly lower IQ scores compared to completers. Post-hoc analyses indicated that participants who discontinued prior to mid-treatment exhibited the greatest intellectual challenges, with comparisons moderate-to-large in strength. IQ and problem solving are likely important factors to assess at pre-treatment in early course schizophrenia trials to identify those most vulnerable to discontinuation.
治疗中断在精神分裂症临床试验中是一个关键挑战,特别是对于早期干预的长期研究。本研究旨在探索认知增强治疗(n=58)和强化支持治疗(n=44)为期 18 个月的多中心试验中门诊早期精神分裂症患者样本(n=102)中治疗中断的预测因素。53 名(52%)参与者中断治疗,治疗组之间的中断率无显著差异。单变量和多变量二元逻辑回归模型探讨了完成和中断治疗的参与者之间关键人口统计学和认知行为结果的差异。显著的多变量预测因素包括智商(线性)和解决问题能力(曲线)。解决问题能力的预测呈凹形,表明最初随着分数的增加,未完成的可能性在增加。然而,在解决问题的得分达到 41 分(低于平均解决问题能力)后,随着表现的提高,非完成者的可能性会降低。未完成者的智商得分明显低于完成者。事后分析表明,在治疗中期前中断治疗的参与者表现出最大的智力挑战,比较强度为中等至较大。智商和解决问题能力可能是早期精神分裂症临床试验中评估的重要因素,以确定那些最容易中断治疗的患者。