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: 10456650
• 负责人: BRANDON A GAUDIANO
• 金额: $ 60.18万
• 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 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10456650
• 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; 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; telephone session; 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）和躁郁症之间存在很大的共发生。这 合并症模式与许多负面结果有关。泡沫和双极的同时出现 疾病与较差的依从性率有关，不遵守是负面的一致预测指标 结果。从精神科住院到门诊护理的过渡是一个风险增加的时期 不遵守，救济和自杀的人口。迄今为止，关于 有效且可行的行为干预措施，旨在提高治疗依从性和参与度 住院后的关键时期，这种高风险的合并症人口。由以前的支持 NIDA的治疗开发赠款，我们开发了一种新颖的社会心理干预措施作为 照常治疗，旨在减少药物滥用，不遵守，情绪症状和其他临床 同时发生的泡沫和躁郁症的高危患者的结果。这种干预措施，称为 “综合治疗依从性计划”（ITAP）是一种创新的方法，结合了面对面的简短 与后续电话会议和家庭/重大参与的订婚会议，作为 住院后六个月的治疗照常治疗。 ITAP干预的试点数据已经很 有希望的，显示出更快，更大的改善结果，例如使用毒品日，情绪症状， 与像往常一样的治疗相比，依从性。但是，需要进一步测试以确认效率和 在典型的临床环境中提供ITAP的可行性。本项目旨在满足 第二阶段治疗开发研究（PA-18-055）。我们建议进行全功率的临床试验 通过随机分配160例合并症和躁郁症的患者评估ITAP，最初 在精神病住院期间招募并在出院后跟随ITAP干预或 安全评估和随访评估（安全）比较状况，均作为辅助手术到 照常社区治疗。我们将培训大师级医院治疗师以提供ITAP/安全和 衡量治疗师对干预措施的保真度。我们将在3（中期）进行盲目的随访评估， 6（治疗后）和9个月的随访。我们假设，与那些接受安全的患者相比 分配给ITAP的使用药物，较低的情绪症状和自杀以及较高的比率将较少 治疗后，遵守精神病和药物滥用药物（基于电子监测） 通过随访维护。我们还将测试提出的ITAP机制（更大的处理）是否 依从性，值 - 行动一致性）介导药物使用和其他临床结果，并测试 结果的潜在主持人（物质类型，性别，基线情绪情节）。完成后，此 研究将通过评估干预措施来填补重要的临床差距 当患者处于最高风险时，在从医院到社区护理过渡的背景下，双相情感障碍。