Treatment for Psychological and Drug Abuse Problems
2013年9月19日 更新者：Michael Kidorf、Johns Hopkins University
Maximizing Effectiveness of Integrated Treatment Approaches
The purpose of the study is to evaluate methods to help people in substance abuse treatment receive better psychiatric care.
Patients enrolled in the study will be offered three months of standard psychiatric treatment, which consists of weekly individual counseling and group counseling, as well as regular appointments with a psychiatrist.
Patients will be randomly assigned to standard psychiatric care or standard psychiatric care plus voucher incentives.
These incentives can be earned by successfully attending all scheduled psychiatric appointments each week.
The investigators expect that patients in the voucher condition will attend more psychiatric sessions, which will lead to greater reductions in psychiatric distress.
研究概览
详细说明
Male and female opioid-dependent patients at Addiction Treatment Services with any current psychiatric disorder (N = 100) will be randomly assigned to one of two psychiatric service conditions: 1) reinforced on-site integrated care (ROIC), with voucher incentives contingent on attending weekly psychiatric sessions; or 2) standard on-site integrated care (SOIC).
Participants in both conditions will receive access to the same schedule and range of psychiatric and substance abuse treatment services.
Participants will be assessed for 3-months post-randomization to determine rates of service utilization and adherence to psychiatric care, changes in scope and severity of psychiatric and psychosocial problems, and rates of drug use and treatment retention.
Positive findings would have considerable heuristic and health care policy and practice implications.
The entire study, including dissemination of the major findings at a national meeting and submission of the first manuscript, is designed to be completed within 2-years.
研究类型
介入性
注册 (实际的)
158
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
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Baltimore、Maryland、美国、21224
- Addiction Treatment Services
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- At least 18 years of age
- Voluntarily seeking psychiatric treatment
- Meets DSM-IV criteria for opiate dependence
- Meets FDA/CSAT guidelines for methadone maintenance
- Meets DSM-IV criteria for at least one current psychiatric disorder
Exclusion Criteria:
- Pregnancy
- Onset or acute exacerbation of a medical illness requiring immediate and intense care
- An organic mental disorder (e.g., delirium, dementia)
- Current participation in psychiatric care
- Mandatory psychiatric treatment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Reinforced On-Site Integrated Care (ROIC)
Patients assigned to this condition will be treated at ATS for psychological problems.
They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor.
They will also be referred to attend group therapy one time per week.
In addition, they will be able to earn a voucher incentive for each week of psychiatric compliance.
|
Patients in this condition will be able to earn a voucher for each week that they have attended all scheduled psychiatric sessions.
These sessions may include individual therapy appointments, group therapy appointments, or psychiatrist appointments.
Each voucher will be worth $25, and can be exchanged for goods and services that will be purchased by a research assistant.
The maximum amount of voucher earnings over the study is $300.
|
|
有源比较器：Standard On-Site Integrated Care (SOIC).
Patients assigned to this condition will be treated at ATS for psychological problems.
They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor.
They will also be referred to attend group therapy one time per week.
|
Patients assigned to this condition will be treated at ATS for psychological problems.
They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor.
They will also be referred to attend group therapy one time per week.
No voucher incentive will be offered in this condition.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychiatric Treatment Adherence
大体时间：Weekly for 12 weeks
|
Patient adherence to all scheduled psychiatric sessions (i.e.
individual, group, psychiatrist) will be measured weekly for 12 weeks.
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Weekly for 12 weeks
|
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Level of Psychiatric Distress
大体时间：Every 4-weeks for 12 weeks
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Patients will complete the Addiction Severity Index (ASI) and the SCL-90 every 4-weeks, for 12-weeks, to measure their current levels of psychiatric distress.
|
Every 4-weeks for 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychiatric Medication Adherence
大体时间：Every 4-weeks
|
Patients will complete a Medication-Taking Scale every 4-weeks to assess their adherence to prescribed psychiatric medications.
|
Every 4-weeks
|
|
Substance Use
大体时间：Weekly for 12-weeks
|
Patients are required to leave weekly urine specimens (for 12-weeks) which are tested for drugs of abuse (opioids, cocaine, benzodiazepines).
|
Weekly for 12-weeks
|
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Treatment Retention
大体时间：Weekly for 12-weeks
|
The length of time subjects remain in treatment is tracked throughout the study.
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Weekly for 12-weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael Kidorf, Ph.D.、Johns Hopkins University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年12月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2010年6月3日
首先提交符合 QC 标准的
2010年6月8日
首次发布 (估计)
2010年6月9日
研究记录更新
最后更新发布 (估计)
2013年9月20日
上次提交的符合 QC 标准的更新
2013年9月19日
最后验证
2013年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.