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

道德伤害综合症创新治疗的实施：2 型混合研究

• 批准号: 10752930
• 负责人: Jeanette Irene Harris
• 金额: --
• 依托单位: VA MAINE HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10752930
• 关键词: Address; Adopted; Adoption; Affect; Anger; Area; Awareness; Behavioral; Belief; Caring; Chaplain; Child; Clinical; Clinical Trials; Collaborations; Conflict (Psychology); Data; Development; Distress; Effectiveness; Effectiveness of Interventions; Equipment; Event; Evidence based intervention; Exposure to; Feeling hopeless; Feeling suicidal; Funding; Future; Group Therapy; Guilt; Health Personnel; Hybrids; Impairment; Individual; Intervention; Language; Life; Literature; Manuals; Measures; Medical; Mental Health; Mental Health Services; Methodology; Methods; Modeling; Moral injury; Morals; Outcome; Penetration; Post-Traumatic Stress Disorders; Procedures; Provider; Psychotherapy; Qualifying; Randomized, Controlled Trials; Reporting; Research Design; Resources; Risk; Running; Services; Severities; Shame; Site; Source; Spirituality; Suicide; Suicide attempt; Suicide prevention; Symptoms; Syndrome; System; Training; Trust; Veterans; Veterans Health Administration; Work; combat; depressive symptoms; disability; effectiveness outcome; effectiveness/implementation study; empowerment; evidence base; experience; forgiveness; functional disability; functional outcomes; group intervention; health management; implementation barriers; implementation evaluation; implementation facilitators; implementation strategy; implementation study; improved; innovation; mass casualty; peer; post implementation; primary outcome; programs; psychologic; psychosocial; randomized, clinical trials; reduce symptoms; suicidal risk; trial comparing; willingness

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.