Trial document





This trial has been registered retrospectively.
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  DRKS00015627

Trial Description

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Title

Psychotherapy in non-affective psychotic outpatients

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Trial Acronym

PINAP

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URL of the Trial

http://evkb.de/ueber-das-evkb/kliniken-institute-zentren/nervensystem/psychiatrie-und-psychotherapie/forschung/projekte/projekte/ambulante-psychotherapie-in-der-behandlung-nicht-affektiver-psychosen.html

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Brief Summary in Lay Language

For many people suffering from psychosis, psychiatric outpatient clinics offer various treatment options. Cognitive behavioral therapy is a form of psychological intervention that is becoming increasingly important in treating psychotic disorders. In recent years, there is growing evidence that patients with psychotic disorders may benefit from cognitive behavioral therapy. However, it is not yet clear whether psychiatric outpatient treatment as usual plus cognitive behavioral therapy for psychosis is superior to psychiatric outpatient treatment as usual alone. The aim of the study is therefore to examine the additional benefit of cognitive behavioral therapy for patients who were already in outpatient treatment for psychosis and receive an extensive set of services. The participants of this study were assigned to either continue with treatment as usual or to attend individual psychotherapy (20 to 25 sessions) in addition to treatment as usual.

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Brief Summary in Scientific Language

Patients with non-affective psychosis (i.e. schizophrenia or schizoaffective disorders) who were treated at a psychiatric outpatient clinic almost always meet criteria for a severe mental illness with an illness duration of two years or more and functional disability. Although patients with non-affective psychosis have shown a high need for mental health care and were a core clientele of psychiatric services, they often have poor access to psychotherapy. This is of particular relevance because international studies have shown the efficacy of cognitive behavioral therapy (CBT) in treating psychotic symptoms (especially positive symptoms) compared to other specific and non-specific psychological interventions. Given the high intensity of care provided by psychiatric outpatient clinics this study aimed to test the additive effectiveness of CBT in patients with schizophrenia and schizoaffective disorders who already receive an extensive and systematic psychiatric outpatient treatment under ecologically valid conditions. We expect that CBT (plus treatment as usual) will lead to a greater decrease of psychotic symptom severity than treatment as usual alone. Medium-term outcomes include the cost-effectiveness of the CBT-treatment and the number of re-hospitalisations (efficiency of CBT).

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Organizational Data

  •   DRKS00015627
  •   2018/10/04
  •   [---]*
  •   yes
  •   Approved
  •   2017-299-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F25 -  Schizoaffective disorders
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Interventions/Observational Groups

  •   Arm 1- Treatment as usual (TAU) involves the standard treatment of patients with non-affective psychosis at a psychiatric outpatient clinic (control group/TAU group). TAU includes regular psychiatric treatment (including medication) and, optionally, other types of interventions offered by mental health professionals (e.g. psychiatric nursing, social work and occupational therapy).
  •   Arm 2 – In addition to the TAU, patients allocated to the intervention group (TAU plus psychotherapy) receive 20 individual sessions of cognitive behavioral therapy (CBT) based on the manual of Lincoln (2014).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The Positive and Negative Syndrome Scale assessed by the Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS, Kay, Opler, & Fiszbein, 1992) is the primary outcome measure to quantify changes in schizophrenia symptoms at post-treatment (6 month after baseline) and at follow-up (12 month after baseline).

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Secondary Outcome

Secondary outcomes include the cost-effectiveness of the CBT-treatment and the number of re-hospitalisations (efficiency of CBT).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/08/01
  •   160
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

diagnosis of schizophrenia (ICD-10: F20) or schizoaffective disorder (ICD-10: F25); age between 18 and 65 years, willingness to undergo random allocation to 20 sessions of outpatient psychotherapy (CBT) or psychiatric outpatient TAU; written informed consent; sufficient knowledge of written and spoken German

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Exclusion Criteria

current diagnosis of substance dependence; organic brain disease, serious and acute somatic illness, serious eating disorder (BMI < 15); acute suicidality at baseline, outpatient psychotherapy within the last two years

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Addresses

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    • Evangelisches Klinikum Bethel (EvKB), Klinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. med.  Martin  Driessen 
    • Remterweg 69-71
    • 33617  Bielefeld
    • Germany
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    •   [---]*
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    • Evangelisches Klinikum Bethel (EvKB), Klinik für Psychiatrie und Psychotherapie
    • Ms.  Dr. rer. nat.  Silvia  Carvalho Fernando 
    • Remterweg 69-71
    • 33617  Bielefeld
    • Germany
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    • Evangelisches Klinikum Bethel (EvKB), Klinik für Psychiatrie und Psychotherapie
    • Ms.  Dr. rer. nat.  Silvia  Carvalho Fernando 
    • Remterweg 69-71
    • 33617  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • Akademie für Psychiatrie und Psychotherapie Ostwestfalen-Lippe e.V.
    • 33602  Bielefeld
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.