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Search / Trial NCT01888627

Integrated Care in Psychotic Disorders With Severe Mental Illness

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Jun 25, 2013

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Schizophrenia Bipolar Disorder Assertive Community Treatment Integrated Care Severe And Persistent Mental Disorder

ClinConnect Summary

This clinical trial is studying a special care program designed for people with severe mental illnesses, particularly those with psychotic disorders like schizophrenia and bipolar disorder. The goal is to see how effective this program, which includes a type of support called Assertive Community Treatment (ACT), is for helping individuals manage their conditions and improve their overall well-being.

To participate in this study, individuals must be at least 12 years old, have a diagnosis of a severe mental illness as defined by certain criteria, and currently need hospitalization for their condition. They must also be members of specific health insurance plans in Germany. If eligible, participants can expect to receive personalized care and support as part of the program, aiming to help them cope better with their symptoms and enhance their quality of life. It's important to know that participation is voluntary, and both treatment and study involvement require separate consent from participants.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • Inclusion criteria for trial participation are identical with the IC model participation criteria and are part of IC contracts with the health insurances. Both, treatment and trial participation were voluntary and needed separate informed consent. Following inclusion criteria will be applied:
  • Member of one of the following health insurances: DAK Gesundheit, HEK, IKK Classic, AOK Rheinland/Hamburg (Germany);
  • Diagnosis of a schizophrenia spectrum disorder (i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS), bipolar disorder, severe major depression with psychotic features, and substance-induced psychotic disorder, all assessed according to DSM-IV with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I);
  • Present confinement for hospitalization because of an acute illness state as assessed by a psychiatrists;
  • Presence of a certain severity of illness as assessed with the Brief Psychiatric Rating Scale (BPRS; 24-item version) with a) BPRS total score \> 40 points and b) fulfillment of one of the following sub syndromes: ≥ 6 points on item 10 (hallucinations), ≥ 6 points on item 11 (unusual thought content), ≥ 6 points on item 15 (conceptual disorganization), ≥ 10 points on items 3 plus 4 (depressive-suicidal syndrome), ≥ 6 points on item 4 (suicidality), ≥ 15 points on items 8, 9 plus 21 (manic syndrome), ≥ 15 points on items 6, 12 plus 20 (disruptive behavior syndrome) and ≥ 15 points on items 13, 16 plus 17 (negative syndrome);
  • Age of ≥ 12 years;
  • Fulfillment of the SPMI condition according to Ruggeri et al.
  • Exclusion criteria The only exclusion criterion for treatment participation was a psychotic disorder due to medical condition.
  • Exclusion Criteria:
  • The only exclusion criterion for treatment participation was a psychotic disorder due to medical condition. Patients with mental retardation (defined as IQ lower than 70 points) are able to participate in treatment, but were excluded for analysis.

About Universitätsklinikum Hamburg Eppendorf

Universitätsklinikum Hamburg-Eppendorf (UKE) is a leading academic medical center in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, UKE integrates state-of-the-art facilities with a multidisciplinary approach, fostering collaboration among top-tier researchers, clinicians, and healthcare professionals. The institution is dedicated to improving patient outcomes by conducting rigorous scientific investigations that address critical health challenges, ultimately contributing to the development of novel therapies and enhancing medical knowledge.

Locations

Hamburg, , Germany

Hamburg, , Germany

Patients applied

0 patients applied

Trial Officials

Martin Lambert, Professor

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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