- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00514839
Brief Intervention for Prescription Drug Misuse in General Hospital (MIMIK)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: C
Control group receiving a booklet on health behavior
|
|
|
Eksperimentel: 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)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Discontinuation of consumption of prescription drugs
Tidsramme: one year
|
one year
|
|
Reduction of consumption of prescription drugs
Tidsramme: one year
|
one year
|
|
Utilization of formal help
Tidsramme: one year
|
one year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Readiness to change consumption of prescription drugs
Tidsramme: one year
|
one year
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 150268661
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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