一项关于Brief Skills Training in Affective and Interpersonal Regulation（Brief STAIR）和网络版STAIR（webSTAIR）在综合初级保健中治疗创伤后应激障碍的混合 1 有效性-实施试验的研究方案。
Study protocol for a hybrid 1 effectiveness-implementation trial of Brief Skills Training in Affective and Interpersonal Regulation (Brief STAIR) and web-administered STAIR (webSTAIR) for posttraumatic stress disorder in integrated primary care.
机构信息
Department of Psychiatry, Boston Medical Center, Boston, MA, USA.
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; National Center for PTSD, Dissemination and Training Division at VA Palo Alto Health Care, Palo Alto, CA, USA.
出版信息
Contemp Clin Trials. 2023 Aug;131:107241. doi: 10.1016/j.cct.2023.107241. Epub 2023 May 25.
BACKGROUND
Posttraumatic stress disorder (PTSD) disproportionally affects low-income, racial and ethnic minoritized communities, where prevalence is high, yet access to evidence-based treatments (EBTs) is low. As such, there is a need to identify effective, feasible, and scalable interventions for PTSD. Stepped care approaches that include brief, low-intensity treatments are one approach to improving access yet have not been developed for adults with PTSD. Our study aims to test the effectiveness of a step one PTSD treatment in primary care while gathering information on implementation to maximize sustainability in the setting.
METHODS
This study will be conducted in integrated primary care in the largest safety net hospital in New England using a hybrid type 1 effectiveness-implementation design. Eligible trial participants are adult primary care patients who meet full or subthreshold criteria for PTSD. Interventions include Brief clinician-administered Skills Training in Affective and Interpersonal Regulation (Brief STAIR) versus web-administered STAIR (webSTAIR) during a 15-week active treatment period. Participants complete assessments at baseline (pre-treatment), 15 weeks (post-treatment), and 9 months (follow-up) post-randomization. We will assess feasibility and acceptability post-trial using surveys and interviews with patients, study therapists, and other key informants, and will assess the preliminary effectiveness of interventions in terms of PTSD symptom change and functioning.
CONCLUSION
This study will provide evidence for the feasibility, acceptability, and preliminary effectiveness of brief, low-intensity interventions in safety net integrated primary care, with the aim of including these interventions in a future stepped care approach to PTSD treatment.
CLINICAL TRIAL NUMBER
NCT04937504.
背景
创伤后应激障碍（PTSD）不成比例地影响低收入、种族和少数民族社区，这些社区的患病率很高，但获得基于证据的治疗方法（EBTs）的机会却很低。因此，需要确定针对 PTSD 的有效、可行和可扩展的干预措施。包括简短、低强度治疗的阶梯式护理方法是改善获取途径的一种方法，但尚未针对 PTSD 成年人开发。我们的研究旨在测试初级保健中一步式 PTSD 治疗的有效性，同时收集实施信息，以最大限度地提高设置的可持续性。
方法
这项研究将在新英格兰最大的医疗保障医院的综合初级保健中进行，采用混合 1 型有效性-实施设计。合格的试验参与者是符合 PTSD 全部或亚阈值标准的成年初级保健患者。干预措施包括在 15 周的积极治疗期间接受简短的临床医生管理的情感和人际调节技能培训（简短 STAIR）与网络管理的 STAIR（网络 STAIR）。参与者在基线（治疗前）、15 周（治疗后）和 9 个月（随访）后进行随机分组评估。我们将在试验后使用患者、研究治疗师和其他主要信息提供者的调查和访谈来评估可行性和可接受性，并根据 PTSD 症状变化和功能来评估干预措施的初步有效性。
结论
这项研究将为在安全网综合初级保健中进行简短、低强度干预的可行性、可接受性和初步有效性提供证据，目的是将这些干预措施纳入未来 PTSD 治疗的阶梯式护理方法中。
临床试验编号
NCT04937504。
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