This trial is active, not recruiting.

Conditions schizophrenia, bipolar disorder
Treatments assertive community treatment, treatment in community mental health center
Sponsor Bispebjerg Hospital
Collaborator Copenhagen Hospital Corporation
Start date January 2004
End date May 2006
Trial size 400 participants
Trial identifier NCT00225602, BBH363004, Cph Hospital Corporation, Østdansk Forskningsforum


The aim of the study is to evaluate the effect of assertive community treatment in Copenhagen in two regions compared with two regions where this treatment was not implemented. The effect on user satisfaction, use of bed days, social network, global assessment of functioning, substance misuse will be evaluated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Adherence to treatment
time frame:

Secondary Outcomes

Experience of violation of personal integrity and privacy in relation to treatment
time frame:
User satisfaction
time frame:
Quality of Life
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Substance misuse
time frame:
Social network
time frame:
Affiliation to labor market
time frame:
Independent living
time frame:
time frame:
Suicidal behaviour
time frame:
Use of psychiatric services
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Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - User of bed days exceeded 40 days last two years; or - 4+ admissions during last two years; or - A second diagnosis of substance misuse; or - Non compliance with medication or outpatient visits in usual settings; or - Being unable to use other existing services Exclusion Criteria: - Forensic patient with a sentence to stay in hospital

Additional Information

Official title Quasi-Experimental Trial of the Effect of Assertive Community Treatment Among Those With Severe Mental Disorder
Principal investigator Merete Nordentoft, Ph.D
Description In area where assertive community treatment was implemented 100 patients had filled in a form regarding their social situation. They were interviewed after one year and asked about user satisfaction and followed up in Danish registers. Register information was extracted concerning vital status, cause of death, use of psychiatric services and criminal record. The same procedure was carried out for a comparison group, carefully matched, from other regions in Copenhagen, where assertive community treatment was not implemented.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.