Brief Intervention for Prescription Drug Misuse in General Hospital (MIMIK)
|ClinicalTrials.gov Identifier: NCT00514839|
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : April 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Substance-related Disorders||Behavioral: Motivational Interviewing||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Brief Intervention for Regular Prescription Drug Use and Prescription Drug Use Disorders in General Hospital|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||February 2009|
No Intervention: C
Control group receiving a booklet on health behavior
Counselling based on Motivational Interviewing plus individualized feedback
Behavioral: Motivational Interviewing
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)
- Discontinuation of consumption of prescription drugs [ Time Frame: one year ]
- Reduction of consumption of prescription drugs [ Time Frame: one year ]
- Utilization of formal help [ Time Frame: one year ]
- Readiness to change consumption of prescription drugs [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514839
|Principal Investigator:||Hans-Juergen Rumpf, Ph.D.||University of Luebeck|