Multisite RCT of STEP-Home: A transdiagnostic skill-based community reintegration workshop

STEP-Home 的多站点随机对照试验：基于跨诊断技能的社区重新融入研讨会

• 批准号: 10400011
• 负责人: Catherine Brawn Fortier
• 金额: --
• 依托单位: VA BOSTON HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-01 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10400011
• 关键词: Address; Adherence; Advanced Development; Anger; Appointment; Attention; Attitude; Automobile Driving; Award; Boston; Caring; Chronic Care; Clinical; Cognitive; Complex; Dangerous Behavior; Data; Diagnosis; Diagnostic; Dropout; Educational workshop; Effectiveness; Emotional; Equipment and supply inventories; Face; Family; Feasibility Studies; Fostering; Freedom; Future; Generations; Group Therapy; Health Care Costs; High Prevalence; Home; Hour; Impairment; Impulsive Behavior; Injury; Intervention; Life; Maintenance; Measures; Mediating; Mental Depression; Mental Health; Military Personnel; Mission; Modality; Modeling; Morbidity - disease rate; Neurologic; Palate; Participant; Patients; Post-Traumatic Stress Disorders; Problem Solving; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recording of previous events; Reporting; Research; Resistance; Schedule; Schools; Services; Site; Societies; Stigmatization; Training; Trauma; Unemployment; Veterans; Work; active control; base; chronic painful condition; clinical diagnosis; cohort; combat; combat veteran; community reintegration; comorbidity; design; effectiveness study; emotion regulation; experience; follow-up; functional status; help-seeking behavior; improved; mild traumatic brain injury; military service; military veteran; mortality; multidisciplinary; novel; operation; post 9/11; post intervention; primary outcome; programs; psychologic; rehabilitation research; research and development; secondary outcome; skill acquisition; skills; skills training; social stigma; standard of care; substance misuse; substance use; success; suicidal risk; therapy development; therapy resistant; traditional therapy; trait; treatment effect

Post-9/11 Veterans from Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) represent a clinically complex group who require non-stigmatizing and multidisciplinary interventions that effectively target their many comorbidities associated with mild TBI and posttraumatic stress disorder. Research indicates that a majority of combat Veterans experience difficulty in readjusting to civilian life after returning from combat including relationship difficulties, impulsive and dangerous behavior, increased substance use, and increased anger control problems. Mental health problems are frequently cited as driving these difficulties. Unfortunately, this group of Veterans has also been demonstrated to be highly resistant to mental health treatment and difficult to engage, showing high rates of appointment no-shows and scheduling difficulties. We propose this growing group of Veterans requires integrative, transdiagnostic (across diagnoses) interventions that will be appropriate for the range of treatment challenges they present while also being palatable and engaging. To address this treatment gap, we have developed the STEP-Home workshop for returning Veterans and demonstrated its feasibility and preliminary effectiveness in a recently completed RR&D SPiRE award (2014- 2016). In this Merit Review proposal, we propose to build on those findings and advance the development of the STEP-Home reintegration workshop to the efficacy stage in a multisite randomized controlled trial. STEP- Home is a 12-week, 2 hour/week reintegration workshop designed to assist all post-9/11 Veterans (with and without a history of psychiatric and/or neurologic diagnoses) with developing skills to improve their anger/impulse control and assist their reintegration to civilian and work life after the military. The core skills and content of the program are novel in their collective use and have not been applied to a Veteran population prior to our SPiRE feasibility study. We will conduct a multisite (TRACTS Boston; TRACTS Houston), randomized controlled trial of STEP-Home (26 workshops; 8 Veterans/workshop; total=208). We have two primary aims in this proposal. First, we will examine the treatment effects of STEP-Home on primary outcomes relative to an active control condition (Present Centered Group Therapy). Second, we will assess the maintenance of treatment effects for our primary outcomes. As an exploratory aim, we will examine treatment effects of STEP- Home on measures of mental health, functional and vocational status and cognitive secondary outcomes targeted indirectly in the workshop. Last, in a second exploratory aim, we will determine if the effect of treatment on the primary outcomes is mediated by the acquisition of core skills/key ingredients (problem solving, emotional regulation, attention training). The successful completion of the aims proposed has the potential to significantly improve skills to foster civilian reintegration in post-9/11Veterans. Furthermore, the STEP-Home SPiRE feasibility study demonstrated that the workshop also serves as a gateway for Veterans who are hesitant to participate in traditional mental health treatments to promote openness and engagement in additional, critically needed, VA services. Given the high rate of treatment resistance in this cohort, developing acceptable interventions that promote treatment engagement and retention, and open the door to future VA care, is necessary to improve functional status and to reduce long-term healthcare costs of untreated mental health illnesses.

9/11 后来自持久自由和伊拉克自由行动 (OEF/OIF) 的退伍军人代表了临床上的 复杂的群体，需要有效针对他们的非侮辱性和多学科干预措施 许多与轻度 TBI 和创伤后应激障碍相关的合并症。研究表明，一个 大多数退伍军人在从战斗中返回后很难重新适应平民生活 包括关系困难、冲动和危险行为、物质使用增加以及 愤怒控制问题。心理健康问题经常被认为是造成这些困难的原因。很遗憾， 这群退伍军人也被证明对心理健康治疗有很强的抵抗力 很难参与，预约缺席率很高并且安排困难。我们提议这个 越来越多的退伍军人需要综合性、跨诊断（跨诊断）干预措施 适合它们提出的一系列治疗挑战，同时也令人愉悦且引人入胜。到 为了解决这一治疗差距，我们为返回的退伍军人开发了 STEP-Home 研讨会， 在最近完成的 RR&D SPiRE 奖项（2014- 2016）。在此优点审查提案中，我们建议以这些发现为基础，推动 STEP-Home 重返社会研讨会在多中心随机对照试验中进入功效阶段。步- Home 是一个为期 12 周、每周 2 小时的重返社会研讨会，旨在帮助所有 9/11 事件后的退伍军人（包括和 没有精神病学和/或神经学诊断史），并培养技能以提高他们的能力 愤怒/冲动控制并协助他们在退伍后重新融入平民和工作生活。核心技能和 该计划的内容在集体使用方面是新颖的，并且之前没有应用于退伍军人群体 参与我们的 SPiRE 可行性研究。我们将进行多站点（TRACTS 波士顿；TRACTS 休斯顿）、随机 STEP-Home 对照试验（26 个研讨会；8 名退伍军人/研讨会；总数 = 208）。我们有两个主要目标 这个建议。首先，我们将检查 STEP-Home 对主要结局的治疗效果（相对于 主动控制条件（当前中心团体治疗）。其次，我们将评估维护 我们的主要结局的治疗效果。作为探索性目标，我们将检查 STEP-的治疗效果 心理健康、功能和职业状态以及认知次要结果测量主页 研讨会上的间接目标。最后，在第二个探索性目标中，我们将确定 对主要结果的治疗是通过获得核心技能/关键成分来调节的（问题 解决、情绪调节、注意力训练）。成功完成所提出的目标 显着提高 9/11 事件后退伍军人重返社会技能的潜力。此外， STEP-Home SPiRE 可行性研究表明，该研讨会还可以作为退伍军人的门户 那些对参加传统心理健康治疗犹豫不决的人，以促进开放和参与 额外的、急需的 VA 服务。鉴于该队列中治疗耐药率很高，正在开发 可接受的干预措施，促进治疗参与和保留，并为未来的 VA 打开大门 护理对于改善功能状态和减少未经治疗的精神疾病的长期医疗费用是必要的 健康疾病。