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Completed

NCT Number: NCT00497848

The Compliance Project Concerning People With Schizophrenia

The purpose of this study is to determine whether individual and/ or system orientated interventions can help the problem of people with schizophrenia dropping out of their drug treatment

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

23 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of psychiatry, Odense University Hospital

Odense, 5000 C, Denmark

About this study

50% of people with schizophrenia do not take the prescribed medication leading to repeating relapses with loss of social and cognitive skills.

The individual intervention is based on "Motivational Interviewing" by Miller and "Concordance Strategies" by R. Gray.It is a cognitive behavioral therapy.

The system orientated intervention is building on principles from quality assurance and clinical risk managing. It seeks to improve the quality in the medical treatment by use of standards, monitoring, audit and root cause analysis,and thereby trying to find weak points in the system and subsequently improve the common practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnoses of schizophrenia or schizoaffective psychosis
  • 23 years or more
  • Ethnic dane
  • Living in the city of Odense.

Exclusion criteria

  • not subject to legal action

Treatment and study plan

Motivational Interviewing

Behavioral

An individual intervention building on the "Motivational Interviewing" by Miller and Rollnick. Several studies has proved effectiveness of this therapy form in improving drug compliance. Patients will be offered individual motivational therapy

Other names: compliance therapy

The System-Orientated Intervention

Other

Principles in this intervention come from "Clinical Risk Managing" and quality assurance. It focuses on daily problems in drug handling, including dropping out of drug therapy, by looking at the system as a whole.Some cases, where patients dropped out of drug therapy will be carefully analysed in order to identify week points in the system, and subsequently alter the instructions for drug therapy, information, reminders and so on.

Other names: Clinical Risk Managing in Handling Compliance Problems

Primary outcomes

  1. compliance assessed on a compliance-scale

    Time frame: follow-up time 6 months

Secondary outcomes

  1. assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Ministry of the Interior and Health, Denmark

Other Gov

Registry information

Official study title

Individual Versus System Orientated Interventions in Handling Drug Related Problems in People With Schizophrenia

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 9, 2007
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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