Integrated Care Including Assertive Community Treatment in Early Psychosis

NCT02037581 | Completed DMC

• 1 other identifier: 01KQ1002B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Improvement of clinical long-term outcome through the implementation of early detection and intervention within a specialized network of integrated care (ACT and hometreatment) for adolescents and young adults with a first episode of psychosis between 12 and 29 years.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

integrated care; hometreatment; assertive community treatment (ACT); psychosis; schizophrenia; bipolar disorder; first episode

Outcome Measures

Primary Outcomes (1)

• Remission of psychosocial functioning

  The primary outcome is the rate (yes / no in %) of patients with combined psycho-functional remission at 12 months study endpoint in the intervention (IC) versus the control condition (CC). The primary objective criterion was regarded as met when the following conditions were fulfilled: 1. Symptomatic remission according to the criterion by Andreasen et al. \[75\]. In the ACCESS III study the criterion was regarded as fulfilled when a symptomatic remission was present at T2 (6 months) and T3 (12 months) and there had been no worsening of symptoms on one of the items in between. 2. Functional remission pursuant to the criterion by Albert et al. \[76\]. In the ACCESS III study the criterion was regarded as fulfilled when a functional remission was present at T2 (6 months) and T3 (12 months) and there had been no worsening of functioning in between.

  12 months

Study Arms (2)

Early detection and Integrated Care

EXPERIMENTAL

The intervention condition consisted of measures to improve early detection and treatment quality (Integrated Care). 1. Interventions for the improvement of early detection. The measures for improved early detection aiming at reducing the duration of untreated psychosis included 4-year measures to improve mental health literacy, reduce stigma and improve service utilization. 2. Measures to improve treatment quality should be achieved through extending the Hamburg model to a cross-age and interdisciplinary Integrated Care model for adolescent and young adult patients with psychotic disorders aged 12-29 years.

Behavioral: Early detection and Integrated Care

Standard Care

OTHER

Historical control group with standard care parallelized regarding age, diagnosis and illness stage, which was treated in the period before the implementation of the intervention conditions. The control group consisted of n=105 patients with early psychosis between the ages of 12 and 29, who had been treated between January 2005 and December 2008. The central differences in comparison with the intervention conditions lie in the lack of measures for the improvement of early detection, the absence of the TACT team, as well as the regular referral to an established psychiatrist with in most cases regular contact frequency.

Behavioral: Standard Care

Interventions

Early detection and Integrated Care BEHAVIORAL

Patients receive integrated care including therapeutic Assertive Community Treatment (TACT)

Early detection and Integrated Care

Standard Care BEHAVIORAL

Standard care as being offered by private psychiatrists

Standard Care

Eligibility Criteria

• Age: 12 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• male/female, age 12-29, adequate knowledge of German language
• Early psychosis critria according to Lewis, Tarrier, \& Haddock, 2002 fullfilled: first or second hospitalisation for psychosis during the past 2 years, duration of illness (psychosis)≤2 years
• Diagnosis chriteria according to DSM-IV TR fullfilled for schizophrenia(295.xx including all subtypes), schizophreniform psychosis(295.40), schizoaffektive disorder(295.70), delusional disorder (297.1), brief psychotic episode 298.8), psychotic disorder (298.9), bipolar I disorder (including 296.44, 296.54 and 296.64) and major depression with psychotic symptoms (296.24 and 296.34).

You may not qualify if:

• One of the following diagnoses according to DSM-IV TR:
• Alkcohol- or substance induced psychosis (z.B. 291.3, 291.5, 292.xx: -.11 or -.12); Psychosis according to somatic disorder(z.B. 293.0, 290.12, 290.20, 290.42, 293.89); pregnancy.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

UHH Hamburg Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Psychotic Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Martin Lambert, Prof.

  UHH Hamburg-Eppendorf

  STUDY DIRECTOR

• Anne Karow, Prof.

  UHH Hamburg-Eppendorf

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: June 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

DE (1)