Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Assertive Community Treatment (ACT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard care<br>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)<br>* 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.<br>* Other names: Assertive Community Treatment, Schizophrenia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, assertive community treatment, quetiapine