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SchizophreniaICEPNCT02037581

Integrated Care Including Assertive Community Treatment in Early Psychosis

A study testing Early detection and Integrated Care in people with Schizophrenia and Bipolar Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 29 years
Conditions the study is for
Schizophrenia, Bipolar Disorder
What is being tested?
Early detection and Integrated Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteGermany
Study dates
Jun 2011to Apr 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 29 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • UHH Hamburg Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

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

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.

Read the detailed description

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:

  1. 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.
  2. Duration of untreated psychosis (DUP) and pathway of care
Being tested
Early detection and Integrated Care, Standard Care
Keywords
integrated care, hometreatment, assertive community treatment (ACT), psychosis, schizophrenia, bipolar disorder, first episode
Medical subject headings
Schizophrenia, Bipolar Disorder, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early detection and Integrated CareBehavioural

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

  • Standard CareBehavioural

    Standard care as being offered by private psychiatrists

Study groups in NCT02037581
Study groupRoleWhat they receive
Early detection and Integrated CareExperimentalThe 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.
Receives: Behavioral: Early detection and Integrated Care
Standard CareOtherHistorical 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.
Receives: Behavioral: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2014 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02037581
Sponsor's protocol ID
01KQ1002B
Acronym
ICEP
Status last verified
Sep 2021
First submitted
14 Jan 2014
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Early detection and Integrated Care in people with Schizophrenia and Bipolar Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission of psychosocial functioning (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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