Trial document





This trial has been registered retrospectively.
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  DRKS00012523

Trial Description

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Title

MOtivation and SociAl Interactive Competence in patients with negative symptoms: Innovative cognitive behavioral therapy and neurobiological correlates (MOSAIC)

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Trial Acronym

MOSAIC-II

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URL of the Trial

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Brief Summary in Lay Language

We aim to improve negative symptoms in patients with psychotic disorders using an innovative cognitive behavioral approach comprising individual and group interventions. Moreover, we will use magnetic resonance imaging to evaluate neurobiological correlates of therapeutical effects and to identify neurobiological outcome predictors.
To allow the evaluation of intervention specific changes in symptoms and neurobiological correlates the intervention group is compared to a control group.

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Brief Summary in Scientific Language

Clinical Trial: Two-phase adaptive randomized two-armed design (monocentric, prospective, single-blind, IIT).
We aim to improve negative symptoms in patients with psychotic disorders using an innovative cognitive behavioral approach comprising individual and group interventions. Moreover, we will use magnetic resonance imaging to evaluate neurobiological correlates of therapeutical effects and to identify neurobiological outcome predictors.
Based on previous results we expect superior effects of the innovative psychotherapie in contrast to a supportive treatment regarding reduction of negative symptoms and improvement of social functioning.

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Organizational Data

  •   DRKS00012523
  •   2018/01/31
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  •   yes
  •   Approved
  •   303/2016BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   U1111-1197-0410 
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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F21 -  Schizotypal disorder
  •   F22 -  Persistent delusional disorders
  •   F23 -  Acute and transient psychotic disorders
  •   F24 -  Induced delusional disorder
  •   F25 -  Schizoaffective disorders
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Interventions/Observational Groups

  •   intervention group (innovative therapy)
    cognitive behavioral therapy combinig 30h individual treatment (one per week for 30 weeks)
    and 30h group treatment (one per week for 30 weeks)
  •   control group:
    supportive psychotherapytherapy combinig 30h individual treatment (one per week for 30 weeks)
    and 30h group treatment (one per week for 30 weeks)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

PANSS Modified Negativesyndrome (Items N1-4, N6, G7, G16)
after 30 weeks of treatment

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Secondary Outcome

Following 30 weeks of treatment the following secundary endpoints will be assessed:

Secondary endpoints
- Clinical Assessment Interview for Negative Symptoms (CAINS)
- Motivation and Pleasure Scale-Self-Report (MAP-SR)
- Social Skills Performance Assessment (SSPA)
- Personal and Social Performance Scale (PSP)
- Global Assessments of Functioning (GAF)
- Lebensqualität-Fragebogen (LRI-r)
- Time Budget Measure
- Calgary Depression Scale for Schizophrenia (CDSS)
- Positive and Negative Syndrome Scale, total score (PANSS)
- Positive and Negative Syndrome Scale, pos. symptoms (PANSS)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/07/13
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1) diagnosis of a psychotic disorder (all F2-diagnoses according to ICD-10) that are diagnosed using the criteria of DSM-IV and SKID
2) relevant manifestation of negative symptoms: PANSS MNS ≥ 10 (Items N1-4, N6, G7 and G16)
3) between 18 - 65 years old
4) outpatient treatment at the time of inclusion
5) sufficient German language skills
6) normal or corrected to normal vision and hearing
7) written informed consent
8) capability to give informed consent (confirmed by an independent psychiatrist in doubtful cases)
9) if there is a legal carer, infomed consent of the carer

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Exclusion Criteria

1) substance dependence as the leading clinical problem
2) severe depressive symptoms (PANNS, G6 > 5)
3) mental retardation (IQ < 70)
4) severe extrapyramidal side effects (MSAS > 11)
5) structural brain lesion
6) current psychotherapeutic treatment (including studies)
7) Exclusion criteria for MRI examinations: non-removable metal objects (i.e. cardiac pacemaker, vascular clamps, etc.),
8) pregnancy,
9) claustrophobia,
10) no consent to be informed about incidental pathological MR-findings.

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Addresses

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    • University Hospital of Tuebingen
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Psychiatrie und Psychotherapie, Universität Tübingen
    • Mr.  Prof. Dr.  Stefan  Klingberg 
    • Calwerstr. 14
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Psychiatrie und Psychotherapie, Universität Tübingen
    • Mr.  Prof. Dr.  Dirk  Wildgruber 
    • Calwerstr. 14
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Psychiatrie und Psychotherapie, Universität Tübingen
    • Mr.  Dr.  Klaus  Hesse 
    • Calwerstr. 14
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Tübingen,Forschungsförderung im Rahmen des AKF - Programm (Angewandte Klinische Forschung)
    • Geissweg 5
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Psychiatrie und Psychotherapie,Universität Tübingen
    • Calwerstr. 14
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/04/08
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Prüfplan
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