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Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders (ACCESS)

This study has been completed.
Sponsor:
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01081418
First received: March 3, 2010
Last updated: March 4, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Behavioral: Assertive Community Treatment (ACT)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Time to Service Disengagement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives.


Enrollment: 120
Study Start Date: April 2005
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard care
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.
 Behavioral: Assertive Community Treatment (ACT)
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.
Other Name: Assertive Community Treatment, Schizophrenia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Other psychotic disorders (e.g., due to medical condition)
  • Mental retardation (IQ lower than 70 points)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081418

Locations
Germany
University Medical Center Hamburg
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Martin Lambert, MD Psychosis Centre, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg
  More Information

No publications provided by Universitätsklinikum Hamburg-Eppendorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Associate Professor Martin Lambert, Psychosis Centre, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg
ClinicalTrials.gov Identifier: NCT01081418     History of Changes
Other Study ID Numbers: EudraCT number: 2005-001069-32
Study First Received: March 3, 2010
Last Updated: March 4, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Schizophrenia, assertive community treatment, quetiapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013