Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005869

Trial Description

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Title

Integrated Care in Early Psychosis (ICEP Study): a 12-month Quasi Experimental Study With Historic Control Group

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Trial Acronym

ICEP

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

The trial is carried out at the Psychosis Center of the Department of Psychiatry and
Psychotherapy and the Department of Child and Adolescent Psychiatry at the University
Medical Center Hamburg-Eppendorf (UKE), which has the responsibility to treat all Child,
adolescent and adult patients within its catchment area of approximately 300.000 habitants.

The IC model was implemented into a network of the Psychosis Center of the University
hospital (UKE), private psychiatrists and psychologists of the UKE catchment area and other
outpatient facilities. As such, following health care structures are part of the model and
could be used by each patients and its relatives according to need:

Specialized inpatient units with attached day-clinics for psychotic disorders; Acute
inpatient units of both Departments; Specialized psychosis outpatient center with a variety
of diagnosis-specific evidence-based individual- and group therapies, low-threshold offers
to promote day structure (e.g., cooking, sport or art groups), an early detection and
intervention service with a mobile early detection team with professionals from the child-
and youth and adult psychiatry, possibility of peer-to-peer and relatives-to-relatives
counseling, relative groups.

A multidisciplinary assertive community treatment (ACT) team, which was implemented
according to guidelines of the Assertive Community Treatment Association and according to
the Dartmouth Assertive Community Treatment Scale (DACTS). Compared to the traditional ACT
model there are two important differences: (1) While traditional ACT models have a
responsibility for patients with severe and persistent mental illness (SPMI) patients
independent from the underlying diagnosis, the present model solely focus on patients with
psychotic disorders; (2) The fidelity of the ACT team was further increased by composing a
team of highly educated psychosis experts (i.e. consultant psychiatrists, psychiatrists,
psychologists, nurses, social worker). Members of the ACT team received diagnosis-specific
training in pharmacotherapy, cognitive behavioral (CBT), dynamic, and/or family
psychotherapy.

A specialized day-clinic for first-episode psychosis patients in the age range of 15-29
years managed by the child- and youth and adult psychiatry; A working support outpatient
center with outpatient and day-clinic treatment facilities; 20 private psychiatrists
participate in the treatment network of the IC model (their duties and responsibilities are
described below).

Further participants of the network are: a psychiatric nursing service, a specialized
housing support service and a specialized psychosis living unit.

Within this network, the main responsibility for the individual patient and his relatives is
generally allocated according to need and preferences to two specific members of the ACT
team, of which one has to be a psychiatrist responsible for pharmacotherapy. However, when
pharmacotherapy is stable and adherence assured, private psychiatrists are allowed to take
over this responsibility. In this case, the specific IC contract with the private
psychiatrists includes several quality assurance guidelines.

Briefly, the staff/client caseload ratio of a single full time employed ACT team member is
1:25. In any case, the first responsibility of the network is a broad assessment of the
psychotic disorder, comorbid psychiatric and somatic disorders, traumatic events, previous
service engagement and medication adherence, social problems, etc. Thereby, a need-adapted
treatment plan will be developed together with the patient, relatives and other caregivers.
If the patient starts IC during inpatient, transition from in- to outpatient care will be
organized. Participant, relatives and other caregiver re-ceive two telephone numbers: one of
the ACT therapists for all contacts within office hours (Monday to Friday from 8 am to 6 pm)
and a 24 hours crisis number for all emergencies or questions outside office hours. The
primary ACT/private psychiatrists subteam is responsible for high-frequent face-to-face
treatment contacts fostering continuity of care, coordinating treatment and social support
(case management), promoting and ensuring service engagement and medication adherence, and
offering intensive need-adapted individual psychotherapy at the earliest possible time
point. Crisis intervention is offered at any time and is always conducted by two ACT members
of which one is the primary ACT therapist. Access to other need-adapted and
diagnosis-specific evidence-based interventions is organized within the specialized
psychosis outpatient center or the work support center, e.g. psychoeducation groups, social
skills training, meta-cognitive training, bipolar psychotherapy groups, etc. Further, all
low-threshold interventions in the outpatient center could be used at any time. Thereby
day-clinic equivalent program could be organized while being in outpatient status. As many
of these patients are at risk for service disengagement and medication non-adherence, a
strict 'no-drop-out' policy is implemented including all admissions out of the catchment
area.

Primary Outcome:

Rate of psychofunctional remission after 12 months of treatment in integrated care (ACT and
hometreatment) versus standard care (SC, historic control group) for the treatment of
adolescents and young adults with early psychosis (12-29 years)

Rationale:

The primary Outcome measure ist the number of patients with psychofunctional remission over
at least 6 months(t2 - t1). Definition of symptomatic remission is according to the
standardized remission criteria(siehe Andreasen et al. 2005). Functional remission is
assessed as GAF ≥ 60. Psychofunctional remission is given, if both criteria are fulfilled
through 6 months.

Secondary Outcomes:

Investigation of the effects of integrated care compared with standard care on:

A. Improvement of psychopathology, daily function and quality of life, B. Improevemnt of
service engagement, compliance and satisfaction with care, C. Increase of Quality Adusted
Life Years (QALY's) through 12 months of treatment.

D. Duration of untreated psychosis (DUP) and pathway of care

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005869
  •   2014/09/10
  •   2014/01/14
  •   yes
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Secondary IDs

  •   NCT02037581  (ClinicalTrials.gov)
  •   01KQ1002B  (Universitätsklinikum Hamburg-Eppendorf)
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Health Condition or Problem studied

  •   Schizophrenia
  •   Bipolar Disorder
  •   F20 -  Schizophrenia
  •   F31 -  Bipolar affective disorder
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Interventions/Observational Groups

  •   Behavioral: Integrated Care with Assertive community treatment with hometreatment, n=120
  •   Behavioral: SC
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Factorial
  •   IV
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Primary Outcome

- Remission of social functioning; time frame: 12 months

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/06/30
  •   240
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   29   Years
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Additional Inclusion Criteria

male/female, age 12-29, adequate knowledge of German language

1. 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

2. 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).

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Exclusion Criteria

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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Hamburg-Eppendorf
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    • UHH Hamburg-Eppendorf
    • Martin Lambert, Prof. 
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    • UHH Hamburg-Eppendorf
    • Martin Lambert, Prof. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.