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) 和躁郁症之间存在大量共存现象。 共病模式与许多负面结果相关 SUD 和躁郁症的同时发生。 疾病与较差的依从率有关，不依从是负面的一致预测因素 从精神病院住院到门诊治疗的过渡是患者面临风险的时期。 迄今为止，关于不依从性、药物复发和自杀的研究还很少。 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 这一高危、合并症人群在出院后的关键时期得到了既往支持。 在 NIDA 的治疗开发资助下，我们开发了一种新型心理社会干预措施作为辅助治疗 照常治疗，旨在减少药物滥用、不依从、情绪症状和其他临床症状 这种干预措施称为“双相情感障碍”和“SUD”同时发生的高危患者的结果。 “综合治疗依从计划”（ITAP）是一种创新方法，结合了简短的面对面治疗 参与会议以及后续电话会议和家人/重要其他人的参与，作为辅助 出院后 6 个月内照常治疗 ITAP 干预的试点数据相当不错。 有前途，显示出更快、更大的结果改善，例如药物使用天数、情绪症状、 并比较了照常治疗的依从性。但是，需要进一步的测试来确认疗效和效果。 在典型临床环境中实施 ITAP 的可行性 本项目旨在满足以下目标： II 期治疗开发研究 (PA-18-055) 我们建议进行全面的临床试验。 最初通过随机分配 160 名患有 SUD 和双相情感障碍的患者来评估 ITAP 在精神病院住院期间招募并在出院后进行跟踪，接受 ITAP 干预或 安全评估和后续评估 (SAFE) 比较条件，均作为辅助条件提供 我们将像往常一样培训硕士水平的医院治疗师来提供 ITAP/SAFE 和 衡量治疗师对干预的忠诚度，我们将在 3 点（治疗中期）进行盲目随访评估。 6 个月（治疗后）和 9 个月的随访，我们勇敢地说，与接受 SAFE 的患者相比，患者。 分配给 ITAP 的人吸毒天数更少、情绪症状和自杀倾向更低、自杀率更高 治疗后坚持精神科和药物滥用药物（基于电子监测） 我们还将通过后续测试来测试是否提出了ITAP（更好的治疗）机制。 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）。 该研究将通过评估干预措施来填补一个重要的临床空白，以“弥合”共病 SUD 和 从医院到社区护理过渡期间的双相情感障碍，此时患者的风险最高。