Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Assertive Community Treatment (ACT)

• Registration Number: NCT01081418
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

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 Timeline

• Study Start: 2005-04
• Primary Completion: 2008-12
• Study Completion: 2009-04
• Status Verified: 2010-03
• Study First Submitted: 2010-03-03
• Study First Submitted QC: 2010-03-04
• Last Update Submitted: 2010-03-04
• Study First Posted: 2010-03-05
• Last Update Posted: 2010-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	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.

Primary Outcome Measures

Name	Time	Method
Time to Service Disengagement	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).

Secondary Outcome Measures

Name	Time	Method
Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives	12 months	Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives.

Trial Locations

Locations (1)

University Medical Center Hamburg; 🇩🇪 Hamburg, Germany