Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependenc

描述（由申请人提供）：本申请涉及广泛的挑战领域（05）比较有效性研究和特定挑战主题，05- da -105：比较药物滥用治疗的偶发性和持续性护理。尽管有越来越多的证据表明物质使用障碍具有慢性性质，至少对于那些进入正式治疗系统的人来说，我们的治疗系统仍然主要依赖于相对较短的、孤立的护理发作（McLellan et al., 2000）。因此，尽管对药物使用障碍的治疗可以导致物质使用的大幅减少，但相当大比例的患者退出相对较快，复发率很高，持续护理往往不足或无法获得。为了延长治疗的积极效果，已经开发了持续护理干预措施，其中一些已被证明是有效的（McKay, 2009）。然而，现有的持续护理模式的潜在影响受到以下因素的限制：早期治疗退出者通常被排除在持续护理研究之外；持续护理的保留率通常很低；个体内部和个体之间对持续护理干预反应的异质性很高，为了产生高影响，持续护理治疗模式必须解决这三个限制。首先，所有患者都应该参加干预，而不仅仅是完成初始阶段治疗的预后较好的患者。第二，需要包括提高持续参与率的方法。最后，当患者最初没有表现出足够的反应，或在稍后的时间点恶化时，必须对干预措施进行修改。在之前NIDA和NIAAA资助的研究中，我们制定了一项延长的持续护理方案，在长达两年的时间里，与常规治疗相比，该方案产生了更好的可卡因和酒精使用结果（McKay等人，2005年，2008年，2009年）。这个协议被称为“电话监控和适应性咨询”（TMAC）。该协议的特点是基于电话的监测和简短的咨询，它结合了动机访谈（MI）和认知行为疗法（CBT）的元素，旨在提高对高风险情况的认识，提高应对能力。此外，该方案还包括一种自适应算法，该算法利用在每次呼叫开始时进行的简短进展评估中获得的数据来确定是否需要改变治疗强度和方式来改善响应。然而，重要的是，TMAC仅在完成至少两周治疗的患者中进行了评估。因此，尚不清楚早期治疗退出的患者——他们可能最需要持续的成瘾治疗模式——能否成功地参与并保留在干预中。此挑战授权的目的是对该协议的新增强版本（TMAC-E）进行初始测试，该版本已经过修改，以解决上述三个限制。在这项新研究中，我们将在公共资助的社区强化门诊项目（IOPs）中招募150名可卡因依赖患者，并将他们随机分为常规治疗或新的持续护理方案。我们将在开始治疗时招募这些人，以确保所有患者都能接受干预。新方案将包含我们现有的持续护理干预的所有要素（例如，电话监测和简短咨询，适应性阶梯式护理，以及低水平的参与激励）。增加持续参与率的其他新特点和组成部分包括：(a)提供低水平的参与奖励；(b)允许患者选择继续护理会议的方式（即电话或面对面）；(c)向有需要的人士提供流动电话；(d)加强社会支助和与社区资源联系的复原模式；(e)更加强调积极的恢复因素；(f)在辍学后进行更系统、更积极的外展。这些特征是通过回顾文献，我们之前的研究结果，以及与患者和咨询师讨论导致持续护理退出的因素而确定的。所有参与者将在项目的第一年注册，并提供一年的持续护理干预。将在基线、3个月、6个月、9个月和12个月随访时获得有关酒精和药物使用、治疗利用和其他多维结果的数据。分析将比较TMAC-E和TAU在每3个月随访期间的总戒断率和这些期间的药物使用频率。次要结局包括与药物使用相关的负面后果、艾滋病毒风险行为以及在随访期间使用昂贵的急性护理药物使用治疗干预措施。这些测试的影响程度也将与早期TMAC干预研究中产生的影响程度进行比较。中介分析将探讨TMAC-E内部的作用机制。TMAC-E的参与率将在6至12个月之间进行检查，以确定在招募更多参与者之前是否需要采取进一步的方法来提高保留率。目前正在进行的准备工作与现有的工作人员和资金将使我们能够开始招聘在一个月内的挑战赠款资金。这笔拨款将创造或保留15个工作岗位。药物使用障碍的治疗通常由相对短暂的护理组成，不能适当地处理这些疾病的慢性、复发性。在之前的工作中，我们已经开发了一种基于电话的适应性持续护理模型，该模型提供了延长的护理，并在几项精心控制的研究中被证明是有效的。拟议的补充将确定新的12个月版本的适应性持续护理方案是否比标准护理更有效，是否比我们之前版本的方案产生更大的效应，该方案包括阶梯式护理算法、患者选择、参与激励和其他一些旨在提高持续参与率的改进。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Challenge Topic, 05-DA-105: Comparing Episodic and Continuous Care for Drug Abuse Treatment. Our treatment system continues to rely primarily on relatively short, isolated episodes of care, despite mounting evidence of the chronic nature of substance use disorders, at least for those who enter the formal treatment system (McLellan et al., 2000). Therefore, although treatment for drug use disorders can lead to substantial reductions in substance use, a significant percentage of patients drop out relatively quickly, rates of relapse are high, and continuing care is often inadequate or unavailable. Continuing care interventions have been developed in an attempt to extend the positive effects of treatment, and some have been shown to be efficacious (McKay, 2009). However, the potential impact of existing continuing care models is limited by the following: ¿ Early treatment dropouts are usually excluded from participation in continuing care studies ¿ Retention rates in continuing care are often low ¿ Heterogeneity of response to continuing care interventions is high, both within and between individuals To have high impact, a continuing care model of treatment must address these three limitations. First, all patients should be enrolled in the intervention, not just the better prognosis patients who complete an initial phase of care. Second, methods to increase rates of sustained participation need to be included. Finally, modifications to the intervention must be available when patients do not exhibit an adequate response initially, or deteriorate at a later point. In prior NIDA and NIAAA funded studies, we have developed an extended continuing care protocol that has generated better cocaine and alcohol use outcomes than treatment as usual over periods as long as two years (McKay et al., 2005, 2008, 2009). This protocol is referred to as "Telephone Monitoring and Adaptive Counseling" (TMAC). The protocol features telephone-based monitoring and brief counseling, which incorporates elements of motivational interviewing (MI) and cognitive-behavioral therapy (CBT) designed to increase recognition of high risk situations and improve coping abilities. In addition, the protocol includes an adaptive algorithm, which makes use of data obtained in a brief progress assessment done at the beginning of each call to determine whether changes in treatment intensity and modality are needed to improve response. Importantly, however, TMAC has been evaluated only in patients who have completed at least two weeks of treatment. Therefore, it is not clear whether patients who are early treatment dropouts-who may be in the greatest need of a continuous model of addiction treatment-can be successfully engaged and retained in the intervention. The purpose of this challenge grant is to conduct an initial test of a new, enhanced version of this protocol (TMAC-E), which has been modified to address the three limitations discussed above. In this new study, we will recruit 150 cocaine dependent patients in publicly funded, community-based intensive outpatient programs (IOPs) and randomize them to treatment as usual or the new continuing care protocol. We will recruit these individuals at entrance to treatment, to make sure that all patients have access to the intervention. The new protocol will contain all the elements of our existing continuing care intervention (e.g., telephone monitoring and brief counseling, adaptive stepped care, and low level incentives for participation). Additional new features and components which have been included to increase rates of sustained participation are: (a) provision of low level incentives for participation; (b) allowing patients to choose the modality of continuing care sessions (i.e., telephone or in person); (c) provision of cell phones to those who need them; (d) modules to strengthen social support and linkage to community resources for recovery; (e) greater emphasis on positive recovery factors; and (f) more systematic and aggressive outreach following dropout. These features were identified through reviews of the literature, our prior research findings, and discussions with patients and counselors regarding factors that contribute to continuing care dropout. All participants will be enrolled in the first year of the project, and provided with one year of the continuing care intervention. Data on alcohol and drug use, treatment utilization, and other multi-dimensional outcomes will be obtained at baseline, and 3, 6, 9, and 12 month follow-ups. Analyses will compare TMAC-E to TAU on rates of total abstinence in each 3-month period of the follow-up and frequency of drug use in those periods. Secondary outcomes include drug use related negative consequences, HIV risk behaviors, and use of expensive, acute care substance use treatment interventions during the follow-up period. The magnitude of the effects in these tests will also be compared to the magnitude of effect sizes generated in earlier studies of the TMAC intervention. Mediation analyses will explore mechanisms of action within TMAC-E. Rates of engagement and participation in TMAC-E will be examined between 6 and 12 months to determine if further methods to increase retention are needed prior to the recruitment of more participants. Preparation work being done now with existing staff and funding will enable us to begin recruitment within a month of challenge grant funding. This grant will create or preserve 15 jobs. Treatment for drug use disorders generally consists of relatively brief episodes of care that do not properly address the chronic, relapsing nature of these disorders. In prior work, we have developed a telephone-based adaptive continuing care model that provides extended care and has proved efficacious in several carefully controlled studies. The proposed supplement will determine whether a new 12 month version of this adaptive continuing care protocol that incorporates stepped care algorithms, patient choice, incentives for participation, and several other improvements designed to increase sustained participation rates will be more effective than standard care and yield larger effect sizes than our prior version of the protocol.