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: 10218024
• 负责人: BRANDON A GAUDIANO
• 金额: $ 62.38万
• 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/10218024
• 关键词: Acute; Adherence; Aftercare; Age of Onset; 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; substance use; 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（SUD）和双相情感障碍之间存在大量的共同发生。这 共病模式与许多负面结果相关。SUD和双极的同时发生 障碍与更差的依从率有关，而不依从是负性的一致预测因素。 结果。从精神病住院治疗到门诊治疗的过渡是这方面风险增加的时期。 不依从、药物复吸和自杀倾向的人群。到目前为止，很少有关于 有效和可行的行为干预措施，旨在提高治疗依从性和参与 这一高风险，共病人群在出院后的关键时期。由以前的 从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， 治疗照常，旨在减少药物滥用，不遵守，情绪症状，和其他临床 合并SUD和双相情感障碍的高危患者的结局。这次干预，被称为 “综合治疗依从性计划”（ITAP）是一种创新的方法，结合了简短的面对面 参与会议，包括后续电话会议和家庭/重要其他参与，作为 出院后6个月内照常治疗。关于综合技术援助方案干预措施的试点数据相当 有希望的，显示出更快和更大的改善结果，如药物使用日，情绪症状， 与常规治疗相比，然而，还需要进一步的测试来确认疗效， 在典型临床环境中实施ITAP的可行性。本项目旨在实现以下目标： II期治疗开发研究（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名患有SUD和双相情感障碍共病的患者来评估ITAP， 在精神病住院期间招募，出院后随访，接受ITAP干预或 安全评估和后续评价（SAFE）比较条件，均作为对 像往常一样治疗。我们将培训硕士水平的医院治疗师，以提供ITAP/SAFE， 测量治疗师对干预的忠诚度。我们将在3（治疗中期）进行盲态随访评估， 6（治疗后）和9个月随访。我们假设，与接受SAFE的患者相比， 分配到ITAP的人使用药物的天数更少，情绪症状和自杀倾向更低， 治疗后对精神病和药物滥用药物的依从性（基于电子监测） 通过后续行动。我们还将测试ITAP的拟议机制（更大的治疗）是否 依从性、价值观-行动一致性）介导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、基线情绪发作）。完成后，这 本研究将通过评价一种干预措施来填补一个重要的临床空白，以“弥合差距”共病SUD， 在从医院到社区护理过渡的背景下，双相情感障碍患者处于最高风险。