The Compliance Project Concerning People With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497848
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : June 27, 2011
Information provided by:
Ministry of the Interior and Health, Denmark

July 6, 2007
July 9, 2007
June 27, 2011
May 2007
July 2009   (Final data collection date for primary outcome measure)
compliance assessed on a compliance-scale [ Time Frame: follow-up time 6 months ]
Same as current
Complete list of historical versions of study NCT00497848 on Archive Site
assessment on a variety of scales concerning subjective well-being, GAF, PANSS-remission,CGI, side-effects. [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
The Compliance Project Concerning People With Schizophrenia
Individual Versus System Orientated Interventions in Handling Drug Related Problems in 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

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.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
  • Behavioral: motivational interviewing
    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 Name: compliance therapy
  • Other: The System-Orientated Intervention
    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 Name: Clinical Risk Managing in Handling Compliance Problems
  • Active Comparator: motivational interviewing
    Intervention: Behavioral: motivational interviewing
  • Experimental: The System Orientated Intervention
    Intervention: Other: The System-Orientated Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
23 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
MIH, Denmark
Not Provided
Not Provided
MD, PhD Bent Nielsen, Department of Psychiatry, Odense, Denmark
Ministry of the Interior and Health, Denmark
Not Provided
Study Director: Bent Nielsen, Ph. D. University of Southern Denmark
Ministry of the Interior and Health, Denmark
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP