Trial document




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  DRKS00020814

Trial Description

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Title

Feasibility study on "Biofeedback and Behavioural therapy for diagnosis-spanning inner restlessness" - FeedRuhe

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Patients with various mental disorders report "inner restlessness" in everyday clinical life. So far there is no established method for the treatment of "inner restlessness". Patients with inner restlessness often report physical complaints that resemble states of tension. Biofeedback is a method for relaxation learning. Connected to a computer, the current tension is displayed visually by a line. The aim is to steer the line downwards via targeted relaxation. The study is a preliminary study for testing a behaviour-therapeutic manual with biofeedback units for the treatment of "inner restlessness". Before and at the end of the treatment, as well as after 3 and after 6 months, biofeedback measurements are taken and questionnaires are given.

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Brief Summary in Scientific Language

Biofeedback and neurofeedback procedures are considered to be established methods for the treatment of various mental illnesses, especially as an additional, supportive method within the framework of behavioral therapy treatment settings. For the symptomatology of "inner restlessness", which is often mentioned by patients with various mental disorders as one of the leading symptoms, there are no empirical conformed therapeutic procedures for treatment. Inner restlessness is often associated with somatic complaints due to the influence of the autonomous nervous system. This is where biofeedback comes into play, which makes physical processes consciously perceptible through the feedback of certain selected physiological parameters in order to learn how to influence them specifically.
The present project is a feasibility study for the implementation of a manual consisting of biofeedback units and behavioral therapeutic elements. Physiological parameters and answers are collected in self-assessment questionnaires for pre-, post-, 3- and 6-month follow-up.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00020814
  •   2020/02/13
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  •   yes
  •   Approved
  •   388/19, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   mentally ill people with the syndrome "inner restlessness"
  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
  •   F40 -  Phobic anxiety disorders
  •   F41 -  Other anxiety disorders
  •   F45 -  Somatoform disorders
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Interventions/Observational Groups

  •   Patients with "inner restlessness" are investigated before, during, after and in the follow-up. The training consists of a combination of 8 biofeedback training sessions and 3 behavioral therapy sessions and lasts for 3 weeks. The contents are all manualized, both the biofeedback sessions and the VT sessions.
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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
  •   N/A
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Primary Outcome

"stresstest" after 3 month

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Secondary Outcome

self-report data in 6 month follow-up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2020/03/05
  •   12
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   55   Years
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Additional Inclusion Criteria

Experience of "inner restlessness" operationalised via response behaviour in the STAI cumulative score >50

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Exclusion Criteria

F2 disease, acute psychotic disorder, existing mental retardation, comprehension difficulties

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Addresses

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    • ZfP Südwürttemberg - Versorgungsforschung Klinik I für Psychiatrie und Psychotherapie Universität Ulm
    • Mr.  Prof. Dr.  Tilman  Steinert 
    • 88214  Ravensburg
    • Germany
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    • ZfP Südwürttemberg - medizinische Psychologie Klinik I für Psychiatrie und Psychotherapie
    • Ms.  Prof. Dr.  Carmen  Uhlmann 
    • Weingartshoferstr. 2
    • 88214  Ravensburg
    • Germany
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    • ZfP Südwürttemberg - Versorgungsforschung Klinik I für Psychiatrie und Psychotherapie Universität Ulm
    • Ms.  Dr.  Petra  Schmid 
    • Weingartshoferstr. 2
    • 88214  Ravensburg
    • Germany
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Sources of Monetary or Material Support

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    • ZfP Südwürttemberg - VersorgungsforschungKlinik I für Psychiatrie und Psychotherapie Universität Ulm
    • Mr.  Prof. Dr.  Tilman  Steinert 
    • 88214  Ravensburg
    • Germany
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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.