Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders (ACCESS)
|ClinicalTrials.gov Identifier: NCT01081418|
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : March 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Assertive Community Treatment (ACT)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2005|
|Primary Completion Date :||December 2008|
|Study Completion Date :||April 2009|
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
- 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).
- Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives [ Time Frame: 12 months ]Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081418
|University Medical Center Hamburg|
|Hamburg, Germany, 20246|
|Principal Investigator:||Martin Lambert, MD||Psychosis Centre, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg|