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临床试验/NCT00514839
NCT00514839已完成2 期

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

University of Luebeck0 个研究点目标入组 126 人开始时间: 2005年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
126
主要终点
Discontinuation of consumption of prescription drugs

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Current treatment for substance abuse problems
  • Terminal illness

结局指标

主要结局

Discontinuation of consumption of prescription drugs

时间窗: one year

Reduction of consumption of prescription drugs

时间窗: one year

Utilization of formal help

时间窗: one year

次要结局

  • Readiness to change consumption of prescription drugs(one year)

研究者

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans-Jürgen Rumpf

PD Dr. Hans-Jürgen Rumpf

University of Luebeck

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