An RCT of a Primary Care-based PTSD Intervention: Clinician-Supported PTSD Coach

 描述（由申请人提供）： 对退伍军人医疗保健的预期影响-拟议的研究有可能通过建立创伤后应激障碍（PTSD）干预在VA初级保健中治疗的退伍军人的有效性来提高VA医疗保健的质量：临床医生支持的PTSD教练（CS PTSD教练）。这项建议将有助于改善初级保健PTSD患者的心理健康，通过教授应对技能来管理PTSD症状，并增加他们对专业心理健康（MH）服务的参与。该计划的长期目标是建立有效的，创新的，易于传播的移动的健康干预措施，以提高退伍军人创伤后应激障碍在退伍军人事务部初级保健的医疗质量。背景-创伤后应激障碍是非常普遍的退伍军人看到在VA初级保健，但是，有一个缺乏证据为基础的简短的创伤后应激障碍干预措施，可以在这种情况下交付。因此，退伍军人与创伤后应激障碍提供转介到专业的MH护理，在循证心理疗法可用。不幸的是，许多患者拒绝这种转诊，或者即使接受转诊，也很少参加足够的疗程以获得适当的治疗。因此，一个显着的差距存在于需要和参与有效的创伤后应激障碍治疗的退伍军人看到专门在VA初级保健。创新技术可以通过增加PTSD治疗的可及性和质量来帮助解决这一需求。弗吉尼亚州的国家创伤后应激障碍中心开发了创伤后应激障碍教练，一个证据知情的自我管理移动的应用程序，提供创伤后应激障碍心理教育，症状监测，应对技能，并链接到社会支持和专业资源。虽然，存在大量证据表明，基于技术的自我管理程序对MH状况是有效的，但单独使用时，自我管理程序往往未得到充分利用。包括临床医生支持在内的干预措施可提高治疗利用率和有效性。因此，我们开发了一种治疗包，将移动的技术与临床医生支持相结合。试点数据表明，参与CS PTSD教练导致临床显着减少PTSD症状和专业MH护理的参与增加。目的-本研究的主要目的是进行一项随机对照试验（RCT），临床支持的创伤后应激障碍教练在VA初级保健与退伍军人临床显着的创伤后应激障碍症状。具体目标是：1）调查CS PTSD教练对PTSD症状严重程度的影响，2）调查CS PTSD教练对两次专业心理健康护理的影响，3）调查患者和供应商对CS PTSD教练的满意度。我们还旨在探索潜在的中介体（即，客观应用程序使用，应对自我效能）和调节器（即，基线PTSD症状严重程度，共病精神症状）的结果。我们还将在四个月的随访期间探索PTSD症状变化的轨迹，以检查参与专业MH治疗和持续使用应用程序是否与症状变化相互作用。研究设计和方法-这是一个为期四年，两个网站，两个手臂的随机对照试验，将比较CS创伤后应激障碍教练的标准转诊到初级保健心理健康整合（PC-MHI）提供者。CS PTSD教练包括四个20-30分钟的课程（面对面或通过电话），为期八周，重点是应用程序使用说明，设置症状减轻目标，并分配特定的PTSD教练活动（例如，评估、管理策略、心理教育读物）供参与者在两次会议之间完成。参与者将是具有临床显著PTSD症状的VA初级护理患者（N = 260）。评估将包括在治疗前（基线）、治疗后以及16周和24周随访时进行的完善的临床访谈和自我报告措施。该研究还将使用VHA管理数据来评估MH治疗参与度，使用客观的应用程序使用数据来评估应用程序的使用，并使用定性方法来评估CS PTSD教练参与者的满意度。

 DESCRIPTION (provided by applicant): Anticipated Impacts on Veterans Healthcare - The proposed study has the potential to improve the quality of VA healthcare by establishing the effectiveness of a Posttraumatic Stress Disorder (PTSD) intervention for Veterans treated in VA primary care: Clinician-Supported PTSD Coach (CS PTSD Coach). This proposal will contribute to improving the mental health of primary care patients with PTSD by teaching coping skills to manage PTSD symptoms and increasing their engagement in specialty mental health (MH) services. The long- term goal of this program is to establish effective, innovative, and easily disseminated mobile health interventions to improve the quality of healthcare for Veterans with PTSD presenting in VA primary care. Background - PTSD is highly prevalent in Veterans seen in VA primary care; however, there is a lack of evidence-based brief PTSD interventions that can be delivered in this setting. Therefore, Veterans with PTSD are offered referrals to specialty MH care where evidence-based psychotherapies are available. Unfortunately, many patients refuse such referrals or if accepted, infrequently attend enough sessions to receive adequate treatment. Consequently, a significant gap exists between need for and engagement in effective PTSD treatment for Veterans seen exclusively in VA primary care. Innovative technology could help address this need by increasing access to and quality of PTSD treatment. VA's National Center for PTSD has developed PTSD Coach, an evidence-informed self-management mobile app that offers PTSD psycho-education, symptom monitoring, coping skills, and links to social support and professional resources. While, substantial evidence exists that technology-based self-management programs for MH conditions are effective, self- management programs when used alone are often underutilized. Interventions that include clinician support increase treatment utilization and effectiveness. Therefore, we have developed a treatment package that combines mobile technology with clinician support. Pilot data indicate participation in CS PTSD Coach leads to clinically significant reductions in PTSD symptoms and increased engagement in specialty MH care. Objectives - The primary objective of this research is to conduct a randomized controlled trial (RCT) of Clinician-Supported PTSD Coach in VA primary care with Veterans with clinically significant PTSD symptoms. The specific aims are to 1) investigate the impact of CS PTSD Coach on PTSD symptom severity, 2) investigate the impact of CS PTSD Coach on engagement in two sessions of specialty mental health care, and 3) investigate patient and provider satisfaction with CS PTSD Coach. We also aim to explore potential mediators (i.e., objective app use, coping self-efficacy) and moderators (i.e., baseline PTSD symptom severity, comorbid psychiatric symptoms) of outcomes. We will also explore trajectories of PTSD symptom change over the four month follow-up period to examine if engagement in specialty MH treatment and continued app use interact with symptom change. Research Design and Methods - This is a four-year, two-site, two-arm RCT that will compare CS PTSD Coach to a standard referral to a Primary Care Mental Health Integration (PC-MHI) provider. CS PTSD Coach consists of four 20-30 minute sessions (in-person or via phone) over eight weeks focused on instructions for app use, setting symptom reductions goals, and assigning specific PTSD Coach activities (e.g., assessments, management strategies, psycho-educational readings) for the participant to complete between sessions. Participants will be VA primary care patients with clinically significant PTSD symptoms (N = 260). Assessments will include well-established clinical interviews and self-report measures that will take place at pre-treatment (baseline), post-treatment, and at 16- and 24-week follow-up. The study will also use VHA administrative data to assess MH treatment engagement, objective app usage data to assess app use, and qualitative methodology to assess CS PTSD Coach participant satisfaction.