Trial document




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  DRKS00013069

Trial Description

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Title

Neural, cognitive, and emotional changes in patients with chronic Depression receiving Cognitive Behavioral Analysis System of Psychotherapy (CBASP) - an f-MRI-supported pilot study

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Trial Acronym

CBASP-Study

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URL of the Trial

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Brief Summary in Lay Language

In patients with chronic depression we want to examine whether the cognitive behavioral analysis system of psychotherapy (CBASP) leads to measurable changes within the brain or the circuitry of neurons. The effectiveness of CBASP has been proven. However, so far it is unclear on which the effect of the procedure is based on.
This is the aim of the study. We want to use magnetic resonance imaging (MRI) of the brain and additional functional MRI, as well as magnetoencephalography (MEG) at the beginning and after the CBASP treatment. Additionaly, using standardized questionnaires, we want to determine whether CBASP leads to changes of joy and pleasure feeling, mood and fear experience. The questionnaires are as follows: the so-called Beck Depression Inventory (BDI), the Snaith-Hamilton pleasure scale, short SHAPS, and the Hamilton Depression Scale (HAMD).

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Brief Summary in Scientific Language

The target group of the study is patients suffering from chronic depression. In the context of specialized university treatment, the patients receive a therapy using the so-called Cognitive Behavioral Analysis System of Psychotherapy (CBASP). Proof of efficacy has been provided for this method in chronic depressive patients. For behavioral therapy, evidence of efficacy was also provided. The effect of behavioral therapy is most likely to be due to changes in the brain which become visible to currently available techniques of imaging, e.g. fMRT. At the same time, there are (still) no studies that investigate the new CBASP treatment method with regard to possible neuronal and neurovegetative effects.
For this purpose, we would like to assess possible neuronal and vegetative effects by means of magnetic resonance tomography (MRI) of the brain and additional functional MRI examination as well as by means of magnetoencephalography (MEG) at the beginning and after the CBASP therapy.
We would also like to examine the patients by means of various psychometric tests at the beginning and after CBASP therapy.
The study investigated psychiatric symptoms such as anxiety, depression, anhedonia, and quality of life in patients and patients at baseline and after CBASP therapy.
The underlying hypothesis is that CBASP therapy leads to measurable neurophysiological changes and, at the same time, correlates to the psychometric tests.

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Organizational Data

  •   DRKS00013069
  •   2017/10/02
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  •   yes
  •   Approved
  •   2017-070, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   F33.9 -  Recurrent depressive disorder, unspecified
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Interventions/Observational Groups

  •   Magnetic resonance imaging (MRI) of the brain, functional MRI, Magnetencephalography (MEG), Scoring of Beck-Depressions-Inventar, Snaith-Hamilton pleasure scale, Hamilton Depression Scale at the beginning and after CBASP-Therapy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome


Brain activity changes in different brain regions at the beginning and at the end of CBASP (Cognitive Behavioral Analysis System of Psychotherapy) therapy measured by functional magnetic resonance imaging

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Secondary Outcome

Score changes of the questionnaires (Beck-Depressions-Inventar, Snaith-Hamilton pleasure scale, Hamilton Depression Scale) at the beginning and at the end of CBASP (Cognitive Behavioral Analysis System of Psychotherapy) therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/23
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients with chronic depression who get a CBASP therapy

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Exclusion Criteria

patients who are younger than 18, patients who are not consentable, patients who take mood-stabilizer or Lithium, patients with MR-specific contraindication, e.g. pace maker etc.

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Addresses

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    • Medizinischer Campus Universität Oldenburg Fakultät für Medizin und GesundheitswissenschaftenUniversitätsklinik für Psychiatrie und Psychotherapie Karl-Jaspers-Klinik
    • Hermann-Ehlers-Str. 7
    • 26160  Bad Zwischenahn
    • Germany
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    • Medizinischer Campus Universität Oldenburg Fakultät für Medizin und Gesundheitswissenschaften Universitätsklinik für Psychiatrie und Psychotherapie
    • Mr.  Dr.  Sebastian  Möller 
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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    • Medizinischer Campus Universität Oldenburg Fakultät für Medizin und Gesundheitswissenschaften Universitätsklinik für Psychiatrie und Psychotherapie
    • Mr.  Dr.  Sebastian  Möller 
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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Sources of Monetary or Material Support

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    • Medizinischer Campus Universität OldenburgFakultät für Medizin und GesundheitswissenschaftenUniversitätsklinik für Psychiatrie und Psychotherapie
    • Ms.  Prof.  Alexandra  Philipsen 
    • Hermann-Ehlers-Str. 7
    • 26160  Bad Zwischenahn
    • Germany
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Status

  •   Recruiting suspended on temporary hold
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Trial Publications, Results and other Documents

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