Improving Anxiety Treatment Engagement and Effectiveness in Primary Care-Mental Health Integration: Multi-site Hybrid I RCT of a Brief Veteran-Centered Anxiety Intervention

背景：许多退伍军人经历了焦虑的损害症状，并在初级保健中寻求治疗， 然而，焦虑在这种情况下却被严重低估。初级保健-心理健康一体化，其中 初级保健中的心理健康临床医生提供简短的治疗，提供了一个解决 这种待遇差距。然而，与短暂PCMHI治疗相容的行为干预措施 格式和能够适应广泛的焦虑介绍是必要的。因此，退伍军人 焦虑技能训练（VAST）旨在以证据为基础，跨诊断，对PCMHI可行， 退伍军人中心。VAST包括临床支持的认知行为治疗（CBT）技术 调整为专门为PCMHI交付设计的手动模块化干预。由于VAST正在 在一个单一的试验点与研究治疗师，下一步的科学步骤是多地点随机对照试验 (RCT)在常规护理中使用PCMHI提供者评估其有效性。重要性/影响：本研究 解决退伍军人护理的精神健康和自杀预防的优先事项，使命法的优先事项，增加 获得护理，提高患者对退伍军人健康管理局（VHA）护理的满意度， 服务研究与开发（HSR&D）关注质量、有效性和效率， 实施科学的研究方法。改善PCMHI中的焦虑治疗将解决 VHA治疗方案，考虑到初级保健中焦虑的高患病率，焦虑患者的倾向 在初级保健中寻求治疗，而不是在专业精神卫生机构中寻求治疗，并且缺乏循证医学。 心理治疗（EBP）方案解决非创伤相关的焦虑。创新：模块化（与标准相比） 干预设计在效率、患者和提供者满意度、功效、有效性 执行和可持续性。其他创新方面包括跨诊断方法， 检查是否忠实，以便为今后的实施提供信息。具体目标：具体目标是：（1）比较 在一项多中心研究中，基线至16周（治疗后）之间VAST与PCMHI常规治疗的患者临床结局 PCMHI提供者提供VAST的RCT，并检查治疗收益是否更有可能 在28周时维持VAST与PCMHI常规护理（随访）;（2）对于分配接受 VAST，探索（a）早期（8周）和（B）总体（16周）治疗反应的患者水平预测因子; 以及（3）对VAST实施进行混合方法过程评估，以检查VAST实施的比率、障碍， 以及实现和维持高保真干预交付的促进者。方法：在这个多地点， 混合I型有效性-实施随机对照试验，将对178名焦虑症状加重的成年退伍军人进行 从两个VHA站点的初级保健中招募。PCMHI提供者将随机提供VAST或 常规护理（常规PCMHI护理，即提供者认为适当的任何护理），受试者将 被随机分配到条件。VAST（最多六次，每两周一次，每次30分钟）包括一个标准的初始和 最后一节课以及多达4个基于CBT技能的模块。主要结局（总体焦虑严重程度和 损害量表）和次要结局（焦虑和抑郁症状严重程度、功能、 将在基线、4、8、12、16（术后）和28周（随访）时评估自杀倾向）。多层次建模 将用于评价患者临床结局从基线至16岁改善更多的假设 与PCMHI常规护理相比，接受VAST的受试者的平均治疗时间为20周。多变量logistic回归将 用于探索早期（8周）和总体（16周）VAST治疗反应的预测因素。一个混合的- 方法过程评估将检查PCMHI提供者的比例，这些提供者实现并保持高水平的 Fidelity VAST交付以及高保真交付的障碍和促进因素。实施/下一步 步骤：VAST将通过几种方式传播给VHA PCMHI领导层和全国范围内的供应商。 策略，以及后续的混合III试验将促进VHA PCMHI的正式实施。

Background: Many Veterans experience impairing symptoms of anxiety and seek treatment in primary care, yet anxiety is highly undertreated in this setting. Primary Care-Mental Health Integration (PCMHI), in which mental health clinicians embedded in primary care provide brief treatment, affords an opportunity to address this treatment gap. However, behavioral interventions that are compatible with the brief PCMHI treatment format and able to accommodate a wide range of anxiety presentations are needed. Accordingly, Veterans Anxiety Skills Training (VAST) was designed to be evidence-based, transdiagnostic, feasible for PCMHI, and Veteran-centered. VAST comprises empirically-supported cognitive-behavioral therapy (CBT) techniques adapted into a manualized modular intervention specifically designed for delivery in PCMHI. As VAST is being piloted at a single site with study therapists, the next scientific step is a multi-site randomized controlled trial (RCT) to evaluate its effectiveness using PCMHI providers in routine care. Significance/Impact: This study addresses Veteran care priorities of mental health and suicide prevention, MISSION Act priorities of increasing access to care and improving patient satisfaction with Veterans Health Administration (VHA) care, and Health Services Research and Development (HSR&D) focus areas of quality, effectiveness, and efficiency as well as implementation science research methods. Improving anxiety treatment in PCMHI will address a major gap in VHA treatment options, given the high prevalence of anxiety in primary care, tendency for patients with anxiety to seek treatment in primary care rather than specialty mental health settings, and absence of Evidence-Based Psychotherapy (EBP) protocols addressing non-trauma related anxiety. Innovation: Modular (vs. standard) intervention designs offer advantages in efficiency, patient and provider satisfaction, efficacy, effectiveness, implementation, and sustainability. Other innovative aspects include the transdiagnostic approach and examination of fidelity to inform future implementation. Specific Aims: The specific aims are to: (1) Compare patient clinical outcomes for VAST vs. PCMHI usual care between baseline and 16 weeks (post) in a multi-site RCT in which PCMHI providers deliver VAST, and examine whether treatment gains are more likely to be maintained for VAST vs. PCMHI usual care at 28 weeks (follow-up); (2) For participants assigned to receive VAST, explore patient-level predictors of (a) early (8 weeks) and (b) overall (16 weeks) treatment response; and (3) Conduct a mixed-methods process evaluation of VAST implementation to examine rates of, barriers to, and facilitators of achieving and sustaining high-fidelity intervention delivery. Methodology: In this multi-site, hybrid type I effectiveness-implementation RCT, 178 adult Veterans with elevated anxiety symptoms will be recruited from primary care at two VHA sites. PCMHI providers will be randomized to deliver either VAST or usual care (routine PCMHI care, meaning whatever care the provider deems appropriate), and participants will be randomized to condition. VAST (up to six biweekly 30-minute sessions) consists of a standard initial and final session as well as up to 4 CBT skills-based modules. The primary outcome (Overall Anxiety Severity and Impairment Scale) and secondary outcomes (anxiety and depressive symptom severity, functioning, quality of life, suicidality) will be assessed at baseline, 4, 8, 12, 16 (post) and 28 weeks (follow-up). Multi-level modeling will be used to evaluate the hypothesis that patient clinical outcomes will improve more from baseline to 16 weeks for participants receiving VAST compared to PCMHI usual care. Multivariate logistic regression will be used to explore predictors of early (8 weeks) and overall (16 weeks) VAST treatment response. A mixed- methods process evaluation will examine the proportion of PCMHI providers who achieve and sustain high- fidelity VAST delivery as well as barriers to and facilitators of high-fidelity delivery. Implementation/Next Steps: VAST will be disseminated to VHA PCMHI leadership and providers nationwide using several strategies, and a follow-up hybrid III trial will facilitate formal implementation in VHA PCMHI.