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确定创伤后应激障碍 (PTSD) 干预措施对 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)该提案将通过教授应对 PTSD 症状的技能并增加他们对专业心理健康 (MH) 服务的参与，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、创新的服务。 ,易于传播的移动健康干预措施，以提高 VA 初级保健中患有 PTSD 的退伍军人的医疗质量 背景 - PTSD 在 VA 初级保健中的退伍军人中非常普遍；但是，缺乏基于证据的简短 PTSD 干预措施。因此，患有创伤后应激障碍 (PTSD) 的退伍军人被转介到可以进行循证心理治疗的专业 MH 护理机构，但不幸的是，许多患者拒绝此类转诊，或者即使接受了转诊，也很少参加足够的治疗来接受充分的治疗。退伍军人对有效 PTSD 治疗的需求和参与之间存在巨大差距，这在 VA 初级保健中可见，创新技术可以通过增加 PTSD 治疗的机会和质量来帮助满足这一需求，VA 国家 PTSD 中心开发了 PTSD 教练。以证据为依据的自我管理移动应用程序，提供 PTSD 心理教育、症状监测、应对技巧以及社会支持和专业资源的链接。同时，大量证据表明，基于技术的 MH 状况自我管理计划是有效的、自我的。 - 管理计划时单独使用的干预措施（包括临床医生支持）常常未得到充分利用，因此，我们开发了一种将移动技术与临床医生支持相结合的治疗方案，表明参与 CS PTSD 教练可在临床上显着减少 PTSD 症状和治疗效果。提高专业 MH 护理的参与度 - 本研究的主要目的是在 VA 初级护理中对具有临床显着 PTSD 症状的退伍军人进行临床医生支持的 PTSD 教练的随机对照试验 (RCT)。 1) CS PTSD 教练对 PTSD 症状严重程度的影响，2) 调查 CS PTSD 教练对参加两次专业心理保健调查的影响，以及 3) 调查患者和提供者对 CS PTSD 教练的满意度。旨在探索结果的潜在中介因素（即客观应用程序使用、应对自我效能）和调节因素（即基线 PTSD 症状严重程度、共病精神症状）我们还将探讨 PTSD 症状的轨迹。在四个月的随访期内进行变化，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 - 这是一项为期四年、两个地点、两个臂的随机对照试验，将比较 CS。向初级保健心理健康整合 (PC-MHI) 提供商提供标准转介的 PTSD 教练 PTSD 教练包括四次 20-30 分钟的课程（面对面或通过电话），为期八周，重点关注应用程序使用说明、设置。症状减轻目标，并分配参与者将是具有临床显着 PTSD 症状的 VA 初级保健患者（N = 260）。访谈和自我报告措施将在治疗前（基线）、治疗后以及 16 周和 24 周随访时进行。该研究还将使用 VHA 管理数据来评估 MH 治疗。参与度、评估应用程序使用的客观应用程序使用数据以及评估 CS PTSD 教练参与者满意度的定性方法。