A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis: The Staged Treatment in Early Psychosis (STEP) Sequential Multiple Assignment Randomized Trial.
A Sequential Adaptive Intervention Strategy Targeting Remission and Functional Recovery in Young People at Ultrahigh Risk of Psychosis: The Staged Treatment in Early Psychosis (STEP) Sequential Multiple Assignment Randomized Trial.
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DOI：
10.1001/jamapsychiatry.2023.1947
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发表时间：
2023-09-01
期刊：
影响因子：
25.8
通讯作者：
Nelson, Barnaby
中科院分区：
文献类型：
--
作者：
McGorry, Patrick D.;Mei, Cristina;Amminger, G. Paul;Yuen, Hok Pan;Kerr, Melissa;Spark, Jessica;Wallis, Nicky;Polari, Andrea;Baird, Shelley;Buccilli, Kate;Dempsey, Sarah-Jane A.;Ferguson, Natalie;Formica, Melanie;Krcmar, Marija;Quinn, Amelia L.;Mebrahtu, Yohannes;Ruslins, Arlan;Street, Rebekah;Wannan, Cassandra;Dixon, Lisa;Carter, Cameron;Loewy, Rachel;Niendam, Tara A.;Shumway, Martha;Nelson, Barnaby
对精神病高危人群进行干预的最佳类型、时机和顺序是什么？在这项包括342名受试者的序贯多分配随机试验中，专门的心理干预（认知行为病例管理[CBCM]）和心理药理学干预（CBCM和抗抑郁药物）在改善缓解和功能恢复方面并不比对照条件更有效。已缓解者的复发率很高。本研究的结果表明，对未缓解的个体添加顺序更专业的心理社会和抗抑郁治疗并没有导致上级结果，强调需要进一步的适应性试验，治疗创新和延长预防复发的护理时间。本序贯多重分配随机试验评估了干预策略对精神病高危个体的疗效。临床试验还没有确定最佳的类型，顺序，以及对精神病高危人群的干预持续时间。确定序贯和适应性干预策略对精神病高危个体的有效性。在澳大利亚墨尔本Orygen的临床项目中进行了早期精神病分期治疗（STEP）序贯多重分配随机试验。在2016年4月至2019年1月期间，招募了12至25岁正在寻求治疗并符合根据风险精神状态综合评估的精神病风险标准的个人。在考虑的1343人中，招募了342人。第一步：6周的支持和问题解决（SPS）;第2步：20周的认知行为病例管理（CBCM）vs SPS;第3步：26周的CBCM+氟西汀vs CBCM+安慰剂，其中包含ω-3脂肪酸或低剂量抗精神病药物的快速失败选项。没有汇款的个人通过这些步骤取得进展;那些汇款的人接受了长达12个月的SPS或监测。全球功能：社会和角色量表（主要结局）、简明精神病评定量表、阴性症状评估量表、蒙哥马利-阿斯伯格抑郁评定量表、生活质量、向精神病转变以及缓解和复发率。样本包括342名参与者（198名女性;平均[SD]年龄，17.7 [3.1]岁）。反映持续症状和功能改善的缓解率在第1、2和3步分别为8.5%、10.3%和11.4%。共有27.2%的患者在任何阶段达到缓解标准。缓解患者的复发率在SPS和监测之间没有显著差异（第1步：65.1% vs 58.3%;第2步：37.7% vs 47.5%）。SPS和CBCM之间以及CBCM与氟西汀和CBCM与安慰剂之间在功能、症状和转换率方面无显著差异。12个月后向精神病的转化率分别为13.5%（整个样本）、3.3%（曾经缓解者）和17.4%（未缓解者）。在这项连续多分配随机试验中，向精神病的转化率为中等，缓解率低于预期，部分反映了雄心勃勃的标准设置以及现实世界治疗保真度和依从性的挑战。虽然所有组均显示出轻度至中度的功能和症状改善，但通常未达到缓解。虽然需要进一步的适应性试验来解决这些挑战，但研究结果证实了大量和持续的发病率，并揭示了对现有治疗的反应性相对较差。ClinicalTrials.gov标识符：NCT 02751632
What are the optimal type, timing, and sequence of interventions for individuals at ultrahigh risk of psychosis? In this sequential multiple assignment randomized trial including 342 individuals, a specialized psychological intervention (cognitive-behavioral case management [CBCM]) and a psychopharmacological intervention (CBCM and antidepressant medication) were not more efficacious than control conditions in improving remission and functional recovery. Relapse rates among individuals who remitted were high. The findings of this study show that addition of sequentially more specialized psychosocial and antidepressant treatment for individuals who did not remit did not lead to superior outcomes, underscoring the need for further adaptive trials, treatment innovation, and an extended duration of care for relapse prevention. This sequential multiple assignment randomized trial evaluates the efficacy of an intervention strategy for individuals at ultrahigh risk of psychosis. Clinical trials have not established the optimal type, sequence, and duration of interventions for people at ultrahigh risk of psychosis. To determine the effectiveness of a sequential and adaptive intervention strategy for individuals at ultrahigh risk of psychosis. The Staged Treatment in Early Psychosis (STEP) sequential multiple assignment randomized trial took place within the clinical program at Orygen, Melbourne, Australia. Individuals aged 12 to 25 years who were seeking treatment and met criteria for ultrahigh risk of psychosis according to the Comprehensive Assessment of At-Risk Mental States were recruited between April 2016 and January 2019. Of 1343 individuals considered, 342 were recruited. Step 1: 6 weeks of support and problem solving (SPS); step 2: 20 weeks of cognitive-behavioral case management (CBCM) vs SPS; and step 3: 26 weeks of CBCM with fluoxetine vs CBCM with placebo with an embedded fast-fail option of ω-3 fatty acids or low-dose antipsychotic medication. Individuals who did not remit progressed through these steps; those who remitted received SPS or monitoring for up to 12 months. Global Functioning: Social and Role scales (primary outcome), Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Montgomery-Åsberg Depression Rating Scale, quality of life, transition to psychosis, and remission and relapse rates. The sample comprised 342 participants (198 female; mean [SD] age, 17.7 [3.1] years). Remission rates, reflecting sustained symptomatic and functional improvement, were 8.5%, 10.3%, and 11.4% at steps 1, 2, and 3, respectively. A total of 27.2% met remission criteria at any step. Relapse rates among those who remitted did not significantly differ between SPS and monitoring (step 1: 65.1% vs 58.3%; step 2: 37.7% vs 47.5%). There was no significant difference in functioning, symptoms, and transition rates between SPS and CBCM and between CBCM with fluoxetine and CBCM with placebo. Twelve-month transition rates to psychosis were 13.5% (entire sample), 3.3% (those who ever remitted), and 17.4% (those with no remission). In this sequential multiple assignment randomized trial, transition rates to psychosis were moderate, and remission rates were lower than expected, partly reflecting the ambitious criteria set and challenges with real-world treatment fidelity and adherence. While all groups showed mild to moderate functional and symptomatic improvement, this was typically short of remission. While further adaptive trials that address these challenges are needed, findings confirm substantial and sustained morbidity and reveal relatively poor responsiveness to existing treatments. ClinicalTrials.gov Identifier: NCT02751632
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