SchizophreniaPhase 4ACCESSNCT01081418
Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders
A Phase 4 study testing Assertive Community Treatment (ACT) in people with Schizophrenia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Assertive Community Treatment (ACT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to Apr 2009
- Phase
- Phase 4
- 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
- Age 18-65 years
- Met the diagnostic criteria of a first- or multiple episode of a schizophrenia spectrum disorders, i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS
- New initiation or current treatment with quetiapine Immediate Release (IR)
Who cannot join
- Other psychotic disorders (e.g., due to medical condition)
- Mental retardation (IQ lower than 70 points)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Assertive Community Treatment (ACT) as Part of Integrated Care Versus Standard Care: a 12-month Trial in Patients With First- and Negatively Selected Multiple-episode Schizophrenia-spectrum Disorders Treated With Quetiapine IR
The study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR.
Read the detailed description
Two catchment areas in Hamburg, Germany with similar population size and health care structures were assigned to offer 12-month ACT (\& IC; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf) or SC (Asklepios Hospital, Department of Psychiatry and Psychotherapy) to 120 first-episode and negatively selected multiple-episode patients with SSD. Primary outcome was the time to Service Disengagement. Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients and relatives perspectives, and service use data.
- Conditions
- Schizophrenia
- Being tested
- Assertive Community Treatment (ACT)
- Keywords
- Schizophrenia, assertive community treatment, quetiapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assertive Community Treatment (ACT)Behavioural
Also called Assertive Community Treatment, Schizophrenia
ACT was structured and implemented according to guidelines of the Assertive Community Treatment Association (ACTA). Team members were highly educated psychosis experts consisting of a consultant psychiatrist, a psychiatrist, two psychologists, and a nurse, all of which received training in cognitive behavioral (CBT), dynamic, and/or family psychotherapy. Study participants could use all treatment options within the integrated care program such as psychoeducation groups, social skills training, family groups, motivational addiction therapy, meta-cognitive training etc.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Experimental | Standard care comprised a treatment network consisting of open and closed inpatient wards, day-clinics, an outpatient centre, and eight private psychiatrists. Each patient was treated by a private psychiatrist or by a psychiatrist in the outpatient centre. Home visits were possible, but office visits were the general rule. Patients were allowed to use all treatment offers in the outpatient centre. Outside office hours, patients could refer themselves to the psychiatric hospital. Psychosocial treatments as supportive therapy, psychoeducation, psychotherapy, and family intervention were provided infrequently and in a less intensive and unsystematic way, and only in the minority of cases. This 'standard of care' definition is in accordance with other studies. Receives: Behavioral: Assertive Community Treatment (ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Service Disengagement
The primary outcome of the study was the time to service disengagement (SD). This primary aim was chosen because the assertive approach of ACT is to prevent service disengagement3 and because service disengagement is a major predictor for relapse and thereby poor long-term outcome.16,17 Service disengagement was present, if a patient repeatedly refuses further treatment despite several attempts of reengagement (phone calls of patient and family in both treatment arms and potentially home visits in the ACT group).
Measured: 12 months
Secondary outcomes (1)
Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives
Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Investigators
- Martin Lambert, MD, Principal investigator, Psychosis Centre, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081418
- Sponsor's protocol ID
- EudraCT number: 2005-001069-32
- Acronym
- ACCESS
- Status last verified
- Mar 2010
- First submitted
- 3 Mar 2010
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Karow A, Brettschneider C, Helmut Konig H, Correll CU, Schottle D, Ludecke D, Rohenkohl A, Ruppelt F, Kraft V, Gallinat J, Lambert M. Better care for less money: cost-effectiveness of integrated care in multi-episode patients with severe psychosis. Acta Psychiatr Scand. 2020 Mar;141(3):221-230. doi: 10.1111/acps.13139. Epub 2020 Jan 12.
PubMed 31814102Karow A, Reimer J, Konig HH, Heider D, Bock T, Huber C, Schottle D, Meister K, Rietschel L, Ohm G, Schulz H, Naber D, Schimmelmann BG, Lambert M. Cost-effectiveness of 12-month therapeutic assertive community treatment as part of integrated care versus standard care in patients with schizophrenia treated with quetiapine immediate release (ACCESS trial). J Clin Psychiatry. 2012 Mar;73(3):e402-8. doi: 10.4088/JCP.11m06875.
PubMed 22490266Lambert M, Bock T, Schottle D, Golks D, Meister K, Rietschel L, Bussopulos A, Frieling M, Schodlbauer M, Burlon M, Huber CG, Ohm G, Pakrasi M, Chirazi-Stark MS, Naber D, Schimmelmann BG. Assertive community treatment as part of integrated care versus standard care: a 12-month trial in patients with first- and multiple-episode schizophrenia spectrum disorders treated with quetiapine immediate release (ACCESS trial). J Clin Psychiatry. 2010 Oct;71(10):1313-23. doi: 10.4088/JCP.09m05113yel. Epub 2010 Mar 23.
PubMed 20361911
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assertive Community Treatment (ACT) as Part of Integrated Care Versus Standard Care: a 12-month Trial in Patients With First- and Negatively Selected Multiple-episode Schizophrenia-spectrum Disorders Treated With Quetiapine IR
- ClinicalTrials.gov ID
- NCT01081418
- Acronym / sponsor ID
- ACCESS / EudraCT number: 2005-001069-32
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, assertive community treatment, quetiapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Mar 2010 (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 study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR.
Detailed description
Two catchment areas in Hamburg, Germany with similar population size and health care structures were assigned to offer 12-month ACT (\& IC; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf) or SC (Asklepios Hospital, Department of Psychiatry and Psychotherapy) to 120 first-episode and negatively selected multiple-episode patients with SSD. Primary outcome was the time to Service Disengagement. Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients and relatives perspectives, and service use data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard care | Experimental | Behavioral: Assertive Community Treatment (ACT)Standard care comprised a treatment network consisting of open and closed inpatient wards, day-clinics, an outpatient centre, and eight private psychiatrists. Each patient was treated by a private psychiatrist or by a psychiatrist in the outpatient centre. Home visits were possible, but office visits were the general rule. Patients were allowed to use all treatment offers in the outpatient centre. Outside office hours, patients could refer themselves to the psychiatric hospital. Psychosocial treatments as supportive therapy, psychoeducation, psychotherapy, and family intervention were provided infrequently and in a less intensive and unsystematic way, and only in the minority of cases. This 'standard of care' definition is in accordance with other studies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- Met the diagnostic criteria of a first- or multiple episode of a schizophrenia spectrum disorders, i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS
- New initiation or current treatment with quetiapine Immediate Release (IR)
Key exclusion criteria (2 listed)
- Other psychotic disorders (e.g., due to medical condition)
- Mental retardation (IQ lower than 70 points)
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 (ACT)Also: Assertive Community Treatment, SchizophreniaACT was structured and implemented according to guidelines of the Assertive Community Treatment Association (ACTA). Team members were highly educated psychosis experts consisting of a consultant psychiatrist, a psychiatrist, two psychologists, and a nurse, all of which received training in cognitive behavioral (CBT), dynamic, and/or family psychotherapy. Study participants could use all treatment options within the integrated care program such as psychoeducation groups, social skills training, family groups, motivational addiction therapy, meta-cognitive training etc. | Behavioural | Standard care |
Primary outcome
Time to Service Disengagement
Time frame: 12 months
The primary outcome of the study was the time to service disengagement (SD). This primary aim was chosen because the assertive approach of ACT is to prevent service disengagement3 and because service disengagement is a major predictor for relapse and thereby poor long-term outcome.16,17 Service disengagement was present, if a patient repeatedly refuses further treatment despite several attempts of reengagement (phone calls of patient and family in both treatment arms and potentially home visits in the ACT group).
1 secondary outcome
Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2010.
- Derived from this study: PubMed 31814102Karow A, Brettschneider C, Helmut Konig H, Correll CU, Schottle D, Ludecke D, Rohenkohl A, Ruppelt F, Kraft V, Gallinat J, Lambert M. Better care for less money: cost-effectiveness of integrated care in multi-episode patients with severe psychosis. Acta Psychiatr Scand. 2020 Mar;141(3):221-230. doi: 10.1111/acps.13139. Epub 2020 Jan 12.
- Derived from this study: PubMed 22490266Karow A, Reimer J, Konig HH, Heider D, Bock T, Huber C, Schottle D, Meister K, Rietschel L, Ohm G, Schulz H, Naber D, Schimmelmann BG, Lambert M. Cost-effectiveness of 12-month therapeutic assertive community treatment as part of integrated care versus standard care in patients with schizophrenia treated with quetiapine immediate release (ACCESS trial). J Clin Psychiatry. 2012 Mar;73(3):e402-8. doi: 10.4088/JCP.11m06875.
- Derived from this study: PubMed 20361911Lambert M, Bock T, Schottle D, Golks D, Meister K, Rietschel L, Bussopulos A, Frieling M, Schodlbauer M, Burlon M, Huber CG, Ohm G, Pakrasi M, Chirazi-Stark MS, Naber D, Schimmelmann BG. Assertive community treatment as part of integrated care versus standard care: a 12-month trial in patients with first- and multiple-episode schizophrenia spectrum disorders treated with quetiapine immediate release (ACCESS trial). J Clin Psychiatry. 2010 Oct;71(10):1313-23. doi: 10.4088/JCP.09m05113yel. Epub 2010 Mar 23.
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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.
Martin Lambert, MD principal investigator
Psychosis Centre, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Assertive Community Treatment (ACT) in people with Schizophrenia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2010. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Service Disengagement (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081418, which also lists 3 linked publications.
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 5 Mar 2010.