Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study

背景：精神伤害综合征（moral injury syndrome，MIS）是一种由心理和行为后遗症所引起的精神创伤 挑战道德，精神或价值观相关信仰的人。MIS的症状可能包括绝望， 无助，失去以前持有的精神信仰，与更高的力量斗争，难以宽恕， 缺乏意义或目的，对自己或他人的信任减少，或顽固的内疚，羞耻或愤怒。个人 管理MIS的人考虑和试图自杀的可能性是同龄人的两倍， 从心理治疗。有几个基于证据的干预精神伤害;这样的干预是一个 这是一种手动的团体干预，称为“建立精神力量（BSS）”。"在以往的随机对照研究中， 试验BSS已被证明可以减少创伤后应激障碍和精神痛苦的症状。这项临床试验将是 首次将MIS症状作为主要结局。假设1：与 PCGT，BSS将显着减少精神损伤综合征的症状（主要有效性结局）。 假设2：与PCGT相比，BSS将显著减少抑郁症状，减少自杀 思维能力和减少功能损伤。（次要有效性结果）。 意义：到目前为止，还没有评估和治疗MIS的标准程序，因此很可能 未经治疗的MIS会导致不良后果，包括自杀。开发实施工具包， BSS在VA设施中广泛使用可以减少MIS对退伍军人心理健康的影响。 创新和影响：到目前为止，还没有资助实施研究治疗MIS， 退伍军人和很少的VA设施提供基于证据的护理MIS。这项研究可以扫清道路， 在VA系统中使MIS的循证护理更容易获得。 具体目标：1.进行混合方法实施前评估，以确定障碍， 为每个地点的业务支助服务实施提供便利，并制定当地实施战略。具体 根据普罗克特和循证质量改进（EBQI）评估实施变量 模型包括可接受性、适当性和可行性。待评估的具体变量将包括a） 利益相关者对业务支助服务的可接受性，B）可用的实施资源，以及c）组织对 添加新的EBP。 2.进行一项随机对照试验，比较BSS与当前中心团体治疗（PCGT）， 在精神伤害结局量表上得分高于临界值（得分> 14）的退伍军人。有效性和功能 结果将由MIS的心理精神发展模型告知。 3.进行混合方法的实施后评估，以比较各牧师的成果 管理与心理健康管理BSS程序。Proctor20，21模型的结果将包括采用，保真度， 渗透和可持续性。与这一框架有关的具体成果包括： 实施，B）在实施BSS方面忠实性，c）提供商对BSS的认识和参考BSS的意愿， 以及d）当研究完成时，意图维持BSS计划的定性报告。 方法：这将是一项第2类混合研究，将执行前和执行后评价与 在4个文化多样的VA中心进行的随机临床试验。 后续步骤和实施：关于障碍和促进因素的数据将用于开发工具包， 与我们在心理健康和自杀预防办公室以及国家牧师的合作伙伴合作 制定全国广播和卫星服务传播计划的服务。我们将与现有的临床工作人员在我们的 研究中心，以便这些研究中心在研究结束后继续提供BSS服务。而且经过 完成这项研究后，BSS领导人将有资格在其他地点培训BSS领导人，为 培训和全国传播。

Background: Moral injury syndrome (MIS) consists of the psychological and behavioral sequelae of experiences that challenge moral, spiritual, or values related beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of previously held spiritual beliefs, struggle with a Higher Power, difficulty with forgiveness, lack of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Individuals managing MIS are up to twice as likely as their peers to consider and attempt suicide, and derive less benefit from psychotherapy. There are few evidence-based interventions for moral injury; one such intervention is a manualized, group intervention called "Building Spiritual Strength (BSS)." In previous randomized controlled trials BSS has been shown to reduce both symptoms of PTSD and spiritual distress. This clinical trial will be one of the first to measure symptoms of MIS as a primary outcome. Hypotheses are: Hypothesis 1: Compared to PCGT, BSS will significantly decrease symptoms of moral injury syndrome (primary effectiveness outcome). Hypothesis 2: Compared to PCGT, BSS will significantly decrease symptoms of depression, decrease suicidal ideation, and reduce functional impairment. (secondary effectiveness outcomes). Significance: To date there are not standard procedures for assessing and treating MIS, so it is likely that untreated MIS is contributing to poor outcomes, including suicides. Developing an implementation toolkit so that BSS is widely available in VA facilities could reduce the impact of MIS on Veterans’ mental health. Innovation and Impact: To date there have not been funded implementation studies on treatments for MIS in Veterans, and very few VA facilities provide evidence-based care for MIS. This study can clear the way to make evidence-based care for MIS more accessible in the VA system. Specific Aims: 1.Conduct a mixed methods pre-implementation evaluation to identify barriers and facilitators for BSS implementation at each site, and to develop local implementation strategies. Specific implementation variables assessed, based on the Proctor and Evidence Based Quality Improvement (EBQI) models include acceptability, appropriateness, and feasibility. Specific variables to be assessed will include a) acceptability of BSS to stakeholders, b) available implementation resources, and c) organizational openness to adding a new EBP. 2. Conduct a randomized controlled trial comparing BSS to Present Centered Group Therapy (PCGT) for Veterans who score above cutoff (score >14) on the Moral Injury Outcomes Scale. Effectiveness and functional outcomes will be informed by the psychospiritual developmental model of MIS. 3. Conduct a mixed methods post-implementation evaluation to compare outcomes across chaplaincy managed vs. mental health managed BSS programs. Proctor20,21model outcomes will include adoption, fidelity, penetration, and sustainability. Specific outcomes related to this framework include a) successful BSS implementation, b) fidelity in implementation of BSS, c) provider awareness of, and willingness to refer to BSS, and d) qualitative reports of intent to maintain the BSS program when the study is complete. Methodology: This will be a type 2 hybrid study, combining pre- and post-implementation evaluations with a randomized clinical trial at 4 culturally diverse VA sites. Next Steps and Implementation: Data on barriers and facilitators will be used to develop a toolkit and collaborate with our partners at the Office of Mental Health and Suicide Prevention and the National Chaplain Service to develop a national dissemination plan for BSS. We will work with existing clinical staffing at our study sites, so that those sites can continue to provide BSS services after the study. Furthermore, after completing this study, BSS leaders will be qualified to train BSS leaders at other sites, creating resources for training and national dissemination.