此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Brief Intervention for Prescription Drug Misuse in General Hospital (MIMIK)

2014年4月1日 更新者:Hans-Jürgen Rumpf、University of Luebeck

Brief Intervention for Regular Prescription Drug Use and Prescription Drug Use Disorders in General Hospital

In a randomized controlled trial, patients recruited in a general hospital and fulfilling criteria for regular consumption (more than 60 days within the last three months), dependence or abuse of prescription drugs will be randomly allocated to two conditions:(1) Intervention group consisting of two counselling sessions based on Motivational Interviewing plus a personalized feedback, (2) Control group receiving a booklet on health behavior.

Outcome assessment will be conducted after 12 months. The hypothesis is that counseling leads to greater reduction in consumption of prescription drugs (including discontinuation) and elevated readiness to change at follow-up.

研究概览

地位

完全的

详细说明

Background: Dependence on prescription drugs (DPD) is highly prevalent, whereby rate of substance specific treatment is low. A pilot study revealed elevated prevalence rates in general hospital patients compared to the general population and a positive attitude of patients suffering from DPD towards counseling. Brief intervention delivered in general hospital might be useful to promote discontinuation of prescription drug use and utilization of formal help.

Objectives: To test the efficacy of a brief intervention based on Motivational Interviewing in proactively recruited general hospital patients randomly allocated to an intervention or a control group. Methods: Patients aged 18 to 69 years are proactively recruited in surgical and internal wards of two general hospitals in the northern German city of Lübeck. Patients with regular use of prescription drugs in the last three months and/or prescription drug dependence or -abuse are randomly assigned to two conditions: (1) an intervention group with two counseling sessions based on Motivational Interviewing plus one individualized feedback based on the Transtheoretical Model of behavior change (TTM) or (2) as usual care. Outcome measures are reduction or discontinuation of prescription drug use and utilization of formal help. The efficacy of the intervention will be examined within a 3 and a 12 month follow up.

Expected impact: Findings are expected to provide evidence for brief interventions for prescription drug misuse to be used in primary care. This would be the first international results confirming such an approach in the field of prescription drug misuse. If a brief interventions would be effective, this could enhance secondary prevention for this under served population. Therefore, data are of great public health interest.

研究类型

介入性

注册 (实际的)

126

阶段

  • 阶段2

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 69年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Prescription drug abuse
  • Prescription drug dependence
  • Regular prescription drug consumption (>60 times/last three months)

Exclusion Criteria:

  • Current treatment for substance abuse problems
  • Terminal illness

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:C
Control group receiving a booklet on health behavior
实验性的:MI
Counselling based on Motivational Interviewing plus individualized feedback
Two sessions of Motivational Interviewing (after baseline assessment and 4 weeks later) plus one individualized feedback based on the Transtheoretical Model of Behavior Change (8 weeks after baseline assessment)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Discontinuation of consumption of prescription drugs
大体时间:one year
one year
Reduction of consumption of prescription drugs
大体时间:one year
one year
Utilization of formal help
大体时间:one year
one year

次要结果测量

结果测量
大体时间
Readiness to change consumption of prescription drugs
大体时间:one year
one year

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。

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

2005年11月1日

初级完成 (实际的)

2008年8月1日

研究完成 (实际的)

2009年2月1日

研究注册日期

首次提交

2007年8月9日

首先提交符合 QC 标准的

2007年8月9日

首次发布 (估计)

2007年8月10日

研究记录更新

最后更新发布 (估计)

2014年4月2日

上次提交的符合 QC 标准的更新

2014年4月1日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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.

Motivational Interviewing的临床试验

3
订阅