Trial document




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  DRKS00014251

Trial Description

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Title

Evaluation of the effect of a psychotherapy program with body movement focus for patients with dissociative seizures.

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Trial Acronym

KÖRDIS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We compare a short term Group psychotherapy Programm with Body movement Focus to a Support Group therapy in patients with psychogenic nonepileptic seizures. The Programm will be hold for 10 weeks with a 90minute session per week. We will treat 6 patients per Group. Measure outcomes will be the seizures frequency and some General Parameters like Depression, anxiety and wor k and social adjustment.

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Brief Summary in Scientific Language

We compare a short term Group psychotherapy Programm with Body movement Focus to a Support Group therapy in patients with psychogenic nonepileptic seizures. The Programm will be hold for 10 weeks with a 90minute session per week. We will treat 6 patients per Group. Measure outcomes will be the seizures frequency and Parameters of a psychometric battery (Liverpool seizure severity scale, PHQ-D, SF-12, DES-12, SDQ-12, SWAS, CGI).

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Organizational Data

  •   DRKS00014251
  •   2018/04/06
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  •   yes
  •   Approved
  •   EA1/185/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   F44.5 -  Dissociative convulsions
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Interventions/Observational Groups

  •   Body movement psychotherapy: participants: 6 patients with dissociative seizures; process: 10 sessions of a modularized treatment program with body movement focus; duration of intervention: 10 weeks; measure times: beginning, after 5 weeks, end of intervention
  •   Support group therapy: participants: 6 patients with dissociative seizures; process: 10 sessions of a support group therapy (guided); duration of intervention: 10 weeks; measure times: beginning, after 5 weeks, end of intervention
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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

2 weeks after completion of the therapy program, patients will get another appointment for checking the seizure calendar for seizure frequency (primary outcome 1). Aditionally they will be asked for their motivation to start an individualized psychotherapy (primary outcome 2). The data will be compared to the equally measured data from before our intervention.

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Secondary Outcome

2 weeks after completion of the therapy program, patients will get another appointment for checking primary and secondary outcome parameter. For checking secondary outcome parameter, we will perform the following psychometric tests: DES-20 (dissociation experiences scale), SDQ-20 (somatic dissociation questionnaire), SF-12 (German tool for general health status “Fragebogen zum Gesundheitszustand”); PHQ-D (German tool for general health status “Gesundheitsfragebogen für Patienten”), WSAS (work and social adkustment scale), CGI (clinical global impression), LSSS (Liverpool seizure severity scale). Those aspects will be measured as secondary endpoints: Seizure severity, depression, anxiety, somatic problems, eating behavior, alcohol, tobacco and drugs, general health status, dissociation rate, social work and adjustment, global impression

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/05/05
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Diagnosis of dissociative seizures (F44.5) proved by an epilepsy Center (with longterm Video EEG)
- not in an ongoing psychotherapy so far
- no suicidality or untreated psychosis / schizophrenic disorder
- no epilepsy as a comorbidity

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Exclusion Criteria

- ongoing psychotherapy
- suicidality
- untreated psychosis / schizophrenic disease
- epilepsy as a comorbidity

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Scientist
    • Ms.  Dr.  Philine  Senf-Beckenbach 
    • Charitéplatz 1
    • 10967  Berlin
    • Germany
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    • Scientist
    • Ms.  Dr.  Philine  Senf-Beckenbach 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Else Kröner Fresenius Stiftung
    • 61352  Bad Homburg
    • Germany
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    • Heidehof Stiftung
    • 70184  Stuttgart
    • Germany
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Status

  •   Enrolling by invitation
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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.