The Compliance Project Concerning People With Schizophrenia

NCT00497848 | Completed DMC

• 1 other identifier: MIH, Denmark
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• compliance assessed on a compliance-scale

  follow-up time 6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

motivational interviewing

ACTIVE COMPARATOR

Behavioral: motivational interviewing

The System Orientated Intervention

EXPERIMENTAL

Other: The System-Orientated Intervention

Interventions

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

Also known as: compliance therapy

motivational interviewing

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.

Also known as: Clinical Risk Managing in Handling Compliance Problems

The System Orientated Intervention

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• not subject to legal action

Sponsors & Collaborators

• Ministry of the Interior and Health, Denmark: lead

Study Sites (1)

Department of psychiatry, Odense University Hospital

Odense, 5000 C, Denmark

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bent Nielsen, Ph. D.

  University of Southern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 6, 2007
• First Posted: July 9, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 27, 2011

Record last verified: 2007-07

Locations

DK (1)