认知康复有效，但我们应该如何提供？使用首发参与者提名的康复结局对传递方法进行适应性随机对照试验。
Cognitive Remediation Works But How Should We Provide It? An Adaptive Randomized Controlled Trial of Delivery Methods Using a Patient Nominated Recovery Outcome in First-Episode Participants.
机构信息
Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
South London and Maudsley NHS Foundation Trust, London, UK.
出版信息
Schizophr Bull. 2023 May 3;49(3):614-625. doi: 10.1093/schbul/sbac214.
BACKGROUND AND HYPOTHESIS
Cognitive remediation (CR) benefits cognition and functioning in psychosis but we do not know the optimal level of therapist contact, so we evaluated the potential benefits of different CR modes.
STUDY DESIGN
A multi-arm, multi-center, single-blinded, adaptive trial of therapist-supported CR. Participants from 11 NHS early intervention psychosis services were independently randomized to Independent, Group, One-to-One, or Treatment-as-usual (TAU). The primary outcome was functional recovery (Goal Attainment Scale [GAS]) at 15-weeks post randomization. Independent and TAU arms were closed after an interim analysis, and three informative contrasts tested (Group vs One-to-One, Independent vs TAU, Group + One-to-One vs TAU). Health economic analyses considered the cost per Quality Adjusted Life Year (QALY). All analyses used intention-to-treat principles.
STUDY RESULTS
We analyzed 377 participants (65 Independent, 134 Group, 112 One-to-One, 66 TAU). GAS did not differ for Group vs One-to-One: Cohen's d: 0.07, -0.25 to 0.40 95% CI, P = .655; Independent vs TAU: Cohen's d: 0.07, -0.41 to 0.55 95% CI, P = .777. GAS and the cognitive score improved for Group + One-to-One vs TAU favoring CR (GAS: Cohen's d: 0.57, 0.19-0.96 95% CI, P = .003; Cognitive score: Cohens d: 0.28, 0.07-0.48 95% CI, P = .008). The QALY costs were £4306 for Group vs TAU and £3170 for One-to-One vs TAU. Adverse events did not differ between treatment methods and no serious adverse events were related to treatment.
CONCLUSIONS
Both active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis and should be adopted within services. Some individuals benefited more than others so needs further investigation.
TRIAL REGISTRATION
ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860Now closed.
背景与假设
认知矫正（CR）有益于精神分裂症患者的认知和功能，但我们并不知道治疗师接触的最佳水平，因此我们评估了不同 CR 模式的潜在益处。
研究设计
一项多臂、多中心、单盲、适应性的治疗师支持的 CR 试验。来自 11 个 NHS 早期干预精神病服务的参与者被独立随机分配到独立、小组、一对一或常规治疗（TAU）。主要结局是随机分组后 15 周的功能恢复（目标实现量表[GAS]）。独立和 TAU 臂在中期分析后关闭，测试了三个信息性对比（小组对一对一，独立对 TAU，小组+一对一对 TAU）。健康经济学分析考虑了每质量调整生命年（QALY）的成本。所有分析均采用意向治疗原则。
研究结果
我们分析了 377 名参与者（65 名独立，134 名小组，112 名一对一，66 名 TAU）。小组与一对一之间的 GAS 没有差异：Cohen's d：0.07，-0.25 至 0.40 95%CI，P=0.655；独立与 TAU 之间：Cohen's d：0.07，-0.41 至 0.55 95%CI，P=0.777。小组+一对一的 GAS 和认知评分均较 TAU 有所提高，有利于 CR（GAS：Cohen's d：0.57，0.19-0.96 95%CI，P=0.003；认知评分：Cohen's d：0.28，0.07-0.48 95%CI，P=0.008）。小组对 TAU 的 QALY 成本为 4306 英镑，一对一对 TAU 的成本为 3170 英镑。治疗方法之间的不良事件没有差异，没有与治疗相关的严重不良事件。
结论
两种积极的治疗师方法都提供了具有成本效益的治疗，有益于早期精神病患者的功能恢复，应在服务中采用。一些人比其他人受益更多，因此需要进一步研究。
试验注册
ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860 现已关闭。
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