Baseline data of a sequential multiple assignment randomized trial (STEP study).
Baseline data of a sequential multiple assignment randomized trial (STEP study).
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DOI：
10.1111/eip.13263
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发表时间：
2022-10
影响因子：
2
通讯作者：
McGorry, Patrick D.
中科院分区：
文献类型：
--
作者：
Hartmann, Jessica A.;Nelson, Barnaby;Amminger, Gunther Paul;Spark, Jessica;Yuen, Hok Pan;Kerr, Melissa J.;Polari, Andrea;Wallis, Nicky;Blasioli, Julie;Dixon, Lisa;Carter, Cameron;Loewy, Rachel;Niendam, Tara A.;Shumway, Martha;McGorry, Patrick D.
研究表明，对精神病（UHR）超高风险个体进行预防性干预可改善症状和功能结局。STEP试验旨在通过顺序研究（1）支持和解决问题，（2）认知行为病例管理和（3）抗抑郁药物的有效性来确定UHR人群中最有效的干预类型，时间和顺序（4）omega-3脂肪酸或低剂量抗精神病药物的嵌入式快速失败选项。本文介绍了样本的招募流程和基线临床特征。STEP是一项序贯多分配随机试验（SMART）。我们提出了基线人口统计学，临床特征，以及这种治疗方法的可接受性和可行性，如参与者从第一次接触到入组试验的流程所示。招募于2016年4月至2019年1月进行。在1343名寻求帮助的年轻人中，402名参与者不符合资格，599名拒绝/脱离，因此共有342名参与者参加了研究。最常见的排除原因是抗抑郁药物的有效处方。85%的入选样本具有非精神病DSM-5诊断，症状/功能测量显示中度临床严重程度和功能障碍。本研究证明了序贯治疗的可接受性和参与者的普遍积极评价。它还显示，在UHR个人的其他试验，精神病发病率和损害的显着水平，表明在这个群体中的护理和治疗是适当的明确需要。
Research has shown that preventative intervention in individuals at ultra-high risk of psychosis (UHR) improves symptomatic and functional outcomes. The STEP trial aims to determine the most effective type, timing and sequence of interventions in the UHR population by sequentially studying the effectiveness of (1) support and problem solving, (2) cognitive-behavioural case management, and (3) antidepressant medication with an embedded fast-fail option of (4) omega-3 fatty acids or low-dose antipsychotic medication. This paper presents the recruitment flow and baseline clinical characteristics of the sample. STEP is a sequential multiple assignment randomised trial (SMART). We present the baseline demographics, clinical characteristics, and acceptability and feasibility of this treatment approach as indicated by the flow of participants from first contact up until enrolment into the trial. Recruitment took place between April 2016 and January 2019. Of 1343 help-seeking young people who were considered for participation, 402 participants were not eligible and 599 declined/disengaged, resulting in a total of 342 participants enrolled in the study. The most common reason for exclusion was an active prescription of antidepressant medication. Eighty-five percent of the enrolled sample had a non-psychotic DSM-5 diagnosis and symptomatic/functional measures showed a moderate level of clinical severity and functional impairment. The present study demonstrates the acceptability and participant’s general positive appraisal of sequential treatment. It also shows, in line with other trials in UHR individuals, a significant level of psychiatric morbidity and impairment, demonstrating the clear need for care in this group and that treatment is appropriate.
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影响因子：
2.9
作者：
Bothwell LE;Avorn J;Khan NF;Kesselheim AS
通讯作者：
Kesselheim AS
影响因子：
--
作者：
Amminger, G. Paul;Schafer, Miriam R.;Berger, Gregor E.
通讯作者：
Berger, Gregor E.
DOI：
10.1186/s13012-014-0132-x
发表时间：
2014-09-30
期刊：
Implementation science : IS
影响因子：
--
作者：
Kilbourne AM;Almirall D;Eisenberg D;Waxmonsky J;Goodrich DE;Fortney JC;Kirchner JE;Solberg LI;Main D;Bauer MS;Kyle J;Murphy SA;Nord KM;Thomas MR
通讯作者：
Thomas MR
影响因子：
64.3
作者：
Kantrowitz, Joshua T.;Woods, Scott W.;Javitt, Daniel C.
通讯作者：
Javitt, Daniel C.
影响因子：
6.9
作者：
Fusar-Poli, P.;Frascarelli, M.;McGuire, P.
通讯作者：
McGuire, P.