Integrated Treatment Adherence Program for Bipolar Disorder at the Time of Prison Release

摘要： 双相情感障碍(BD)是一种严重的、致残性的、高度复发的疾病，其比例不成比例。 在刑事司法系统中。BD增加了囚犯的几种不良后果的风险，包括情绪 不稳定，自杀未遂，吸毒复发，以及高重复监禁率。尽管如此 严重的负面后遗症，高达70%的BD囚犯入狱后没有接受心理健康治疗 放手。在重新进入社区后，缺乏对BD患者持续的精神健康治疗的参与 使不良后果和未经治疗的BD的后果的风险永久化的一个潜在因素(例如， 冲动、物质使用)可能会极大地加剧建立稳定生活条件的困难(例如， 适足住房、合法就业)重新进入社区。因此，迫切需要采取干预措施来 在这一脆弱的过渡期间，促进参与BD的治疗。R34试验的主要目的是 有效性试验(RFA-MH-17-612)旨在开发和确定以下项目的可行性、可接受性和潜力 再入时社区治疗坚持(CARE)计划的未来进展。关怀是一种创新 结合循证认知行为、家庭和电话外展策略的干预措施 在BD期间促进治疗参与度和改善临床结果 社区重新进入。根据我们的试点工作，护理将包括3个人和1个家庭在监狱里， 随后在释放后长达6个月的11次简短电话联系。鉴于其强度适中， 辅助性、使用社区心理健康辅导员、电话管理、护理 设计时着眼于社区实施。它的作用机制(即，增加价值- 行动一致性、加强社会支持和服务联系，所有这些都是为了促进治疗参与度， 从而改善临床结果)进一步很好地匹配重新进入的实际和临床需要 个人。研究的开发阶段将产生治疗手册、培训手册和保真度 在12名即将获释的BD囚犯的公开审判中进行测试。这项初步研究将审查 拟议的招募方法、研究设计、干预和培训的可行性和可接受性 通过随机选择40名BD即将获释的囚犯进行正常治疗(TAU)的计划，增强了 通过监测和紧急转介，或加强TAU加护理。主要结果将是情绪 症状在出院后6个月。次要结果包括：自杀念头/行为、物质 使用率、再逮捕率、就业和住房稳定性。我们还将探索差异化参与 CARE所谓的行动机制。据我们所知，这项提议是第一次尝试 为囚犯中的BD制定和试点有针对性的过渡性干预措施，为 更大的临床试验(R01)，以评估护理的有效性，以改善这一严重的临床结果 在从监狱到重新进入社区的脆弱过渡期间，患病、高风险、未得到充分研究的人口。

Abstract: Bipolar disorder (BD) is a serious, disabling, and highly recurrent illness that is disproportionately represented in the criminal justice system. BD increases risk for several adverse outcomes for prisoners, including mood instability, suicide attempts, substance use relapse, and high rates of repeat incarceration. Despite these serious negative sequelae, up to 70% of prisoners with BD do not receive mental health treatment upon prison release. Lack of engagement in ongoing mental health treatment for BD upon community re-entry represents one potent factor that perpetuates risk for adverse outcomes, and consequences of untreated BD (e.g., impulsivity, substance use) may greatly exacerbate difficulties in establishing stable living conditions (e.g., adequate housing, legal employment) at community re-entry. Thus, there is a critical need for interventions to facilitate engagement with treatment for BD during this vulnerable transition. The primary aim of this R34 pilot effectiveness trial (RFA-MH-17-612) is to develop and establish the feasibility, acceptability, and potential for future uptake of the Community treatment Adherence at Re-Entry (CARE) program. CARE is an innovative intervention that combines evidence-based cognitive-behavioral, family, and telephone outreach strategies to promote treatment engagement and improve clinical outcomes for prisoners with BD during the period of community re-entry. Informed by our pilot work, CARE will include 3 individual and 1 family session in prison, followed by 11 brief telephone contacts for up to 6 months post-release. Given its moderate intensity, adjunctive nature, use of community mental health counselors, and telephone administration, CARE has been designed with an eye toward community implementation. Its mechanisms of action (i.e., increasing values- action consistency, enhancing social supports, and service linkage, all to promote treatment engagement, thereby improving clinical outcomes) are further well matched to the practical and clinical needs of re-entering individuals. The development phase of the study will result in a treatment manual, training manual, and fidelity scales, to be tested in an open trial of 12 prisoners with BD nearing prison release. The pilot study will examine feasibility and acceptability of the proposed recruitment methods, research design, intervention, and training program by randomizing 40 prisoners with BD nearing prison release to treatment as usual (TAU), enhanced with monitoring and emergency referral, or to enhanced TAU plus CARE. The primary outcome will be mood symptoms in the 6 months post-release. Secondary outcomes include: suicidal ideation/behaviors, substance use, re-arrest rates, and employment and housing stability. We will also explore differential engagement of CARE’s purported mechanisms of action. To our knowledge, this proposal represents the first attempt to develop and pilot a targeted transitional interventional for BD among prisoners, laying the groundwork for a larger clinical trial (R01) to evaluate the effectiveness of CARE for improving clinical outcomes for this seriously ill, high risk, understudied population during the vulnerable transition from prison to community re-entry.