Integrated care program for severe mental illness
Integrated Care in Patients With a Psychotic Disorder Fulfilling Definition of Severe Mental Illness (ACCESS-II Study)
This study is testing a new care program that combines different types of support for people with severe mental illnesses, like psychotic disorders, to see if it helps them feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT01888627 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an integrated care program that includes therapeutic assertive community treatment (ACT) for individuals with severe and persistent mental illnesses, particularly psychotic disorders. Conducted at the Psychosis Center of the University Medical Center Hamburg-Eppendorf, the program incorporates a network of specialized inpatient units, outpatient facilities, and multidisciplinary teams to provide comprehensive care. The approach aims to enhance treatment outcomes through coordinated services tailored to the needs of patients and their families.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with schizophrenia spectrum disorders or other severe mental illnesses who are currently hospitalized due to acute illness.
Not a fit: Patients with mild mental health conditions or those not meeting the specific diagnostic criteria may not benefit from this integrated care approach.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and treatment outcomes for patients with severe mental illnesses.
How similar studies have performed: Previous studies have shown positive outcomes with integrated care models for severe mental illnesses, suggesting that this approach is promising and builds on established practices.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hamburg
- University Hospital Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Martin Lambert, Professor — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Martin Lambert, Professor
- Email: lambert@uke.de
- Phone: 004940741057670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.