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

基于初级保健的 PTSD 干预的随机对照试验：临床医生支持的 PTSD 教练

• 批准号: 9079205
• 负责人: Eric Roland Kuhn
• 金额: --
• 依托单位: VETERANS ADMIN PALO ALTO HEALTH CARE SYS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-10-01 至 2020-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9079205
• 关键词: Address; Address; Aftercare; Aftercare; Assessment tool; Assessment tool; Brief Psychotherapy; Brief Psychotherapy; Caring; Caring; Cellular Phone; Cellular Phone; Clinical; Clinical; Clinical Practice Guideline; Clinical Practice Guideline; Coping Skills; Coping Skills; Data; Data; Education; Educational process of instructing; Educational process of instructing; Effectiveness; Effectiveness; Emotional; Emotional; Feedback; Feedback; Fright; Fright; Goals; Goals; Health; Health; Health Personnel; Health Personnel; Healthcare; Healthcare; Instruction; Instruction; Intervention; Intervention; Interview; Interview; Learning; Learning; Link; Link; Measures; Measures; Mediator of activation protein; Mediator of activation protein; Medical; Medical; Mental Health; Mental Health; Mental Health Services; Mental Health Services; Methodology; Methodology; Modeling; Modeling; Monitor; Monitor; Outcome; Outcome; Participant; Participant; Patient Care; Patient Self-Report; Patient Self-Report; Patients; Patients; Persons; Persons; Pharmaceutical Preparations; Pharmaceutical Preparations; Post-Traumatic Stress Disorders; Post-Traumatic Stress Disorders; Primary Health Care; Primary Health Care; Provider; Provider; Psychotherapy; Psychotherapy; Randomized; Randomized; Randomized Clinical Trials; Randomized Clinical Trials; Randomized Controlled Trials; Randomized Controlled Trials; Reading; Reading; Reporting; Reporting; Research; Research; Research Design; Research Design; Research Methodology; Research Methodology; Resources; Resources; Self Efficacy; Self Efficacy; Self Management; Self Management; Services; Services; Severities; Severities; Site; Site; Social support; Social support; Stigmatization; Symptoms; Symptoms; Technology; Technology; Telephone; Testing; Time; Time; Veterans; Veterans; Visit; Visit; arm; arm; base; base; clinically significant; clinically significant; comorbidity; coping; coping; economic cost; economic cost; effective therapy; effective therapy; effectiveness testing; evidence base; evidence base; follow-up; follow-up; functional disability; functional disability; functional status; functional status; health care quality; health care quality; health care settings; improved; improved; improved outcome; improved outcome; innovation; innovation; innovative technologies; innovative technologies; mHealth; mHealth; medical specialties; medical specialties; mobile application; mobile application; mobile computing; mobile computing; mortality; mortality; patient oriented; patient oriented; primary care setting; primary care setting; programs; programs; psychiatric symptom; psychiatric symptom; psychoeducation; psychoeducation; psychoeducational; racial and ethnic; racial and ethnic; reduce symptoms; reduce symptoms; satisfaction; satisfaction; self-management program; shared decision making; shared decision making; socioeconomics; socioeconomics; stress related disorder; symptom treatment; symptom treatment; treatment as usual; treatment as usual; treatment center

 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.

 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）干预的有效性来提高VA医疗保健的质量：在VA初级保健中治疗的退伍军人：临床医生支持的PTSD PTSD教练（CS PTSD教练）。该建议将通过教授应对技巧来管理PTSD症状并增加其参与特殊心理健康（MH）服务，从而有助于改善PTSD初级保健患者的心理健康。该计划的长期目标是建立有效，创新且易于传播的移动健康干预措施，以提高VA初级保健中PTSD的退伍军人质量。背景-PTSD在VA初级保健中看到的退伍军人高度普遍；但是，缺乏基于证据的简短PTSD干预措施。在这种情况下。创新的技术可以拒绝此类转诊或接受，很少会参加足够的课程接受足够的治疗。因此，仅在VA初级保健中看到的退伍军人的有效PTSD治疗和参与之间存在很大的差距。创新技术可以通过增加对PTSD治疗的访问和质量来帮助满足这一需求。弗吉尼亚州国家PTSD国家中心开发了PTSD教练，这是一个有证据的自我管理移动应用程序，可提供PTSD心理教育，症状监测，应对技能以及与社会支持和专业资源的链接。尽管存在大量证据，表明针对MH条件的基于技术的自我管理计划是有效的，而单独使用时的自我管理程序通常不足以利用。包括临床支持的干预措施增加了治疗利用和有效性。因此，我们开发了一个将移动技术与临床支持相结合的治疗方案。指示参与CS PTSD教练的试验数据可导致PTSD症状的临床显着降低，并增加了专业MH护理的参与度。目标 - 这项研究的主要目标是与具有临床意义的PTSD症状的退伍军人进行VA初级保健中临床医生支持的PTSD教练的随机对照试验（RCT）。具体目的是1）研究CS PTSD教练对PTSD症状严重程度的影响，2）研究CS PTSD教练对两次特殊心理保健的参与的影响，以及3）研究患者和提供者对CS PTSD教练的满意度。我们还旨在探索潜在的介体（即客观的应用程序使用，应对自我效能感）和主持人（即基线PTSD症状严重程度，合并症的精神病症状）。我们还将在四个月的随访期内探索PTSD症状变化的轨迹，以检查参与特殊MH治疗的参与并继续使用App使用与症状变化相互作用。研究设计和方法 - 这是一个四年，两次两端的RCT，将将CS PTSD教练与标准推荐与初级保健心理健康整合（PC-MHI）提供商进行比较。 CS PTSD教练在八个星期内由四个20-30分钟的课程（亲自或通过电话）组成，重点是用于应用程序使用的说明，降低症状目标，并为参与者分配特定的PTSD教练活动（例如，评估，管理策略，心理教育策略，心理教育式阅读），参与者将为VA初级保健患者提供临床上重要的PTSD PRTSD症状（N = 2600）。评估将包括良好的临床访谈和自我报告措施，这些措施将在治疗前（基线），治疗后以及16周和24周的随访。该研究还将使用VHA管理数据来评估MH治疗参与度，客观应用程序使用数据以评估应用程序使用以及定性方法，以评估CS PTSD教练参与者的满意度。