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
基本信息
- 批准号:10218024
- 负责人:
- 金额:$ 62.38万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AcuteAdherenceAftercareAge of OnsetAmbulatory CareBehavior TherapyBehavioralBipolar DisorderCaringClinicalClinical TrialsCommunitiesCompetenceConduct Clinical TrialsDataDisease remissionDrug abuseDrug usageEffect Modifiers (Epidemiology)EvaluationFamilyFeeling suicidalFutureGenderGeneral PopulationGrantHospitalizationHospitalsIndividualInpatientsInterventionMeasuresMediatingModelingMonitorMoodsMorbidity - disease rateNational Institute of Drug AbuseOutcomePatient NoncompliancePatient Self-ReportPatientsPatternPersonsPharmaceutical PreparationsPopulationProgram DevelopmentRandomizedRandomized Controlled TrialsRelapseReportingResearchRiskSamplingSeveritiesSubstance Use DisorderSubstance abuse problemSuicideSymptomsTelephoneTestingTimeTrainingTreatment EfficacyViolenceVisitadherence ratebaseblindclinical practicecomorbiditycritical perioddesigndual diagnosisefficacy testingfollow up assessmentfollow-uphigh riskhospital readmissionimprovedinnovationintervention programmedication compliancemood symptommortalitynoveloutcome predictionprogramspsychosocialrecruitreduced substance abuseresearch and developmentsafety assessmentsubstance usetherapy designtherapy developmenttreatment adherencetreatment as usualtreatment effecttreatment responsetrial design
项目摘要
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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BRANDON A GAUDIANO其他文献
BRANDON A GAUDIANO的其他文献
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{{ truncateString('BRANDON A GAUDIANO', 18)}}的其他基金
Effectiveness of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with SMI
多组成部分移动医疗干预对改善 SMI 患者出院后护理过渡的有效性
- 批准号:
10502609 - 财政年份:2022
- 资助金额:
$ 62.38万 - 项目类别:
Development of an adjunctive video-based suicide prevention intervention immediately following psychiatric hospitalization
在精神病院住院后立即开发基于视频的辅助自杀预防干预措施
- 批准号:
10296677 - 财政年份:2020
- 资助金额:
$ 62.38万 - 项目类别:
Development of an adjunctive video-based suicide prevention intervention immediately following psychiatric hospitalization
在精神病院住院后立即开发基于视频的辅助自杀预防干预措施
- 批准号:
9894972 - 财政年份:2020
- 资助金额:
$ 62.38万 - 项目类别:
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 - 财政年份:2019
- 资助金额:
$ 62.38万 - 项目类别:
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 - 财政年份:2019
- 资助金额:
$ 62.38万 - 项目类别:
Mobile After-Care Support Intervention for Patients with Schizophrenia following Hospitalization
精神分裂症患者住院后的移动善后支持干预
- 批准号:
9924664 - 财政年份:2018
- 资助金额:
$ 62.38万 - 项目类别:
Narrative intervention to disseminate ACT for depression in primary care
在初级保健中传播针对抑郁症的 ACT 的叙事干预
- 批准号:
9220647 - 财政年份:2015
- 资助金额:
$ 62.38万 - 项目类别:
Narrative intervention to disseminate ACT for depression in primary care
在初级保健中传播针对抑郁症的 ACT 的叙事干预
- 批准号:
9002100 - 财政年份:2015
- 资助金额:
$ 62.38万 - 项目类别:
Effectiveness of Psychosocial Treatment for Inpatients with Psychosis
心理社会治疗对住院精神病患者的有效性
- 批准号:
8696880 - 财政年份:2013
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$ 62.38万 - 项目类别:
Technology-Assisted Assessment of Post-Hospital Adherence in Schizophrenia
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- 批准号:
8703805 - 财政年份:2013
- 资助金额:
$ 62.38万 - 项目类别:
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