Assertive Community Treatment (ACT) in Schizophrenia Spectrum Disorders

NCT01081418 | Completed Phase 4

• 1 other identifier: EudraCT number: 2005-001069-32
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia, assertive community treatment, quetiapine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives

  12 months

Study Arms (1)

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.

Behavioral: Assertive Community Treatment (ACT)

Interventions

Assertive Community Treatment (ACT) BEHAVIORAL

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.

Also known as: Assertive Community Treatment, Schizophrenia

Standard care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Other psychotic disorders (e.g., due to medical condition)
• Mental retardation (IQ lower than 70 points)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg

Hamburg, Hamburg, 20246, Germany

Location

Related Publications (3)

• 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.

  PMID: 31814102 DERIVED

• Karow 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.

  PMID: 22490266 DERIVED

• Lambert 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.

  PMID: 20361911 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Community Mental Health Services

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Martin Lambert, MD

  Psychosis Centre, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 5, 2010
• Study Start: April 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 5, 2010

Record last verified: 2010-03

Locations

DE (1)