SchizophreniaNCT00225602
Assertive Community Treatment in Copenhagen
A study testing Assertive Community Treatment and Treatment in Community Mental Health Center in people with Schizophrenia and Bipolar Disorder, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- Assertive Community Treatment and Treatment in Community Mental Health Center
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Forensic patient with a sentence to stay in hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quasi-Experimental Trial of the Effect of Assertive Community Treatment Among Those With Severe Mental Disorder
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.
Read the detailed 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.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- Assertive Community Treatment, Treatment in Community Mental Health Center
- Keywords
- Schizophrenia, Assertive community treatment
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assertive Community TreatmentBehavioural
Treatment in Community Mental Health CenterBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to treatment
Secondary outcomes (10)
Experience of violation of personal integrity and privacy in relation to treatment
User satisfaction
Quality of Life
Substance misuse
Social network
Affiliation to labor market
Independent living
Crime
Suicidal behaviour
Use of psychiatric services
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startJan 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Hospital Corporation
- Investigators
- Merete Nordentoft, Ph.D, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225602
- Sponsor's protocol ID
- BBH363004
- Other IDs
- Cph Hospital Corporation, Østdansk Forskningsforum
- Status last verified
- Sep 2005
- First submitted
- 22 Sep 2005
- Last updated
- 26 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quasi-Experimental Trial of the Effect of Assertive Community Treatment Among Those With Severe Mental Disorder
- ClinicalTrials.gov ID
- NCT00225602
- Acronym / sponsor ID
- BBH363004
- Conditions
- Schizophrenia, Bipolar Disorder
- Keywords
- Schizophrenia, Assertive community treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen Hospital Corporation
- Study start
- Jan 2004
- Study completion
- May 2006
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Forensic patient with a sentence to stay in hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assertive Community Treatment | Behavioural | – |
| Treatment in Community Mental Health Center | Behavioural | – |
Primary outcome
Adherence to treatment
10 secondary outcomes
Experience of violation of personal integrity and privacy in relation to treatment
User satisfaction
Quality of Life
Substance misuse
Social network
Affiliation to labor market
Independent living
Crime
Suicidal behaviour
Use of psychiatric services
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft, Ph.D principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assertive Community Treatment and Treatment in Community Mental Health Center in people with Schizophrenia and Bipolar Disorder, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2005.