RCT to Improve Post-Hospital Treatment Adherence for Comorbid Substance Use and Bipolar Disorders

随机对照试验可提高共病药物使用和双相情感障碍的出院后治疗依从性

• 批准号: 10015339
• 负责人: BRANDON A GAUDIANO
• 金额: $ 65.67万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-10 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10015339
• 关键词: Acute; Adherence; Aftercare; Age of Onset; Alcohol or Other Drugs use; Ambulatory Care; Behavior Therapy; Behavioral; Bipolar Disorder; Caring; Clinical; Clinical Trials; Communities; Competence; Conduct Clinical Trials; Data; Disease remission; Drug abuse; Drug usage; Effect Modifiers (Epidemiology); Evaluation; Family; Feeling suicidal; Future; Gender; General Population; Grant; Hospitalization; Hospitals; Individual; Inpatients; Intervention; Measures; Mediating; Modeling; Monitor; Moods; Morbidity - disease rate; National Institute of Drug Abuse; Outcome; Patient Noncompliance; Patient Self-Report; Patients; Pattern; Persons; Pharmaceutical Preparations; Population; Program Development; Randomized; Randomized Controlled Trials; Relapse; Reporting; Research; Risk; Sampling; Severities; Substance Use Disorder; Substance abuse problem; Suicide; Symptoms; Telephone; Testing; Time; Training; Treatment Efficacy; Violence; Visit; adherence rate; base; blind; clinical practice; comorbidity; critical period; design; dual diagnosis; efficacy testing; follow up assessment; follow-up; high risk; hospital readmission; improved; innovation; intervention program; medication compliance; mood symptom; mortality; novel; outcome prediction; programs; psychosocial; recruit; reduced substance abuse; research and development; safety assessment; therapy design; therapy development; treatment adherence; treatment as usual; treatment effect; treatment response; trial design

There is a substantial co-occurrence between substance use disorders (SUDs) and bipolar disorder. This comorbidity pattern is associated with a host of negative outcomes. The co-occurrence of SUDs and bipolar disorder is related to even poorer adherence rates, and nonadherence is a consistent predictor of negative outcomes. The transition from psychiatric hospitalization to outpatient care is a time of heightened risk in this population for nonadherence, substance relapse, and suicidality. To date, there is very little research on effective and feasible behavioral interventions designed to improve treatment adherence and engagement in this high-risk, comorbid population at the critical period following hospital discharge. Supported by a previous treatment development grant from NIDA, we developed a novel psychosocial intervention as an adjunct to treatment as usual, designed to reduce substance abuse, nonadherence, mood symptoms, and other clinical outcomes among high-risk patients with co-occurring SUDs and bipolar disorder. This intervention, called the “Integrated Treatment Adherence Program” (ITAP), is an innovative approach that combines brief in-person engagement sessions with follow-up phone sessions and family/significant other involvement, as an adjunct to treatment as usual over 6 months post-discharge. Pilot data on the ITAP intervention have been quite promising, showing faster and larger improvements in outcomes such as drug days using, mood symptoms, and adherence compared to treatment as usual. However, further testing is needed to confirm the efficacy and feasibility of delivering ITAP in typical clinical settings. The present project is designed to meet the objectives of Stage II treatment development research (PA-18-055). We propose to conduct a fully-powered clinical trial evaluating ITAP by randomly assigning 160 patients with comorbid SUDs and bipolar disorder, initially recruited during a psychiatric hospitalization and followed after discharge, to either the ITAP intervention or a Safety Assessment and Follow-up Evaluation (SAFE) comparison condition, both delivered as adjuncts to community treatment as usual. We will train master's level hospital therapists to deliver ITAP/SAFE and measure therapist fidelity to the intervention. We will conduct blind follow-up assessments at 3 (mid-treatment), 6 (post-treatment), and 9 month follow-ups. We hypothesize that, compared to those receiving SAFE, patients assigned to ITAP will have fewer days using drugs, lower mood symptoms and suicidality, and higher rates of adherence to psychiatric and substance abuse medications (based on electronic monitoring) at post-treatment maintained through follow-up. We also will test whether the proposed mechanisms of ITAP (greater treatment adherence, values-action consistency) mediate substance use and other clinical outcomes, as well as test potential moderators of outcomes (substance type, gender, baseline mood episode). When completed, this study will fill an important clinical gap by evaluating an intervention to “bridge the gap” for comorbid SUD and bipolar disorder in the context of transition from hospital to community care, when patients are at highest risk.

物质使用障碍(SUDS)和双相情感障碍之间有很大的共生性。这 共病模式与一系列负面结果相关。肥皂泡和躁郁症的并存 混乱与更低的依从率有关，而不遵守是负面的一致预测因素 结果。从精神科住院到门诊护理的过渡是这一风险增加的时期。 不坚持、物质复发和自杀的人口。到目前为止，关于这方面的研究很少 旨在提高治疗依从性和参与度的有效和可行的行为干预 在出院后的关键时期，这些高危、并存的人群。由以前的 来自NIDA的治疗发展赠款，我们开发了一种新的心理社会干预作为辅助 照常治疗，旨在减少药物滥用、不坚持、情绪症状和其他临床症状 伴发肥胖症和双相情感障碍的高危患者的结局。这一干预被称为 “综合治疗依从性计划”(ITAP)，是一种创新的方法，结合了简单的面对面 参与会议，包括后续电话会议和家庭/重要的其他参与，作为 出院后6个月以上照常治疗。关于ITAP干预的试点数据相当 前景看好，在结果方面显示出更快和更大的改善，如吸毒天数、情绪症状、 与常规治疗相比，依从性更强。然而，还需要进一步的测试来证实其有效性和 在典型临床环境下实施ITAP的可行性。本项目旨在实现以下目标 第二阶段治疗开发研究(PA-18-055)。我们建议进行一项全面的临床试验 通过随机分配160名合并肥胖症和双相情感障碍的患者来评估ITAP 在精神科住院期间招募并在出院后接受ITAP干预或 安全评估和后续评估(SAFE)比较条件，均作为附件交付 照常进行社区治疗。我们将培训硕士级别的医院治疗师，以提供ITAP/SAFE和 测量治疗师对干预的忠诚度。我们将在3点(治疗中期)进行盲法随访评估， 6个月(治疗后)，9个月随访。我们假设，与接受安全治疗的患者相比， 被分配到ITAP的患者使用药物的天数将更少，情绪症状和自杀率更低， 在治疗后坚持使用精神药物和药物滥用药物(基于电子监测) 通过后续行动保持。我们还将测试ITAP(更大治疗)的拟议机制 坚持，价值观-行动的一致性)调节物质使用和其他临床结果，以及测试 结果的潜在调节因素(物质类型、性别、基线情绪事件)。完成后，这 这项研究将通过评估一种干预措施来填补一项重要的临床空白，以“弥合”并发的SUD和 在从医院过渡到社区护理的背景下，当患者处于最高风险时，双相情感障碍。