Trial document





This trial has been registered retrospectively.
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  DRKS00012268

Trial Description

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Title

Symptom management in complex post-traumatic stress disorder, view and experience of patients and their relatives: A mixed methods approach

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose is to describe specific patient characteristics, levels of symptom burden and perspectives of adult inpatients with a complex posttraumatic stress disorder and their relatives in relation to their experiences, needs, facilitators of and barriers to symptom management.

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Brief Summary in Scientific Language

The purpose of this mixed methods study with a sequential exploraroty design, is to describe specific patient characteristics, levels of symptom burden and perspectives of adult inpatients with a complex posttraumatic stress disorder and their relatives in relation to their experiences, needs, facilitators of and barriers to symptom management.

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Organizational Data

  •   DRKS00012268
  •   2017/04/21
  •   [---]*
  •   yes
  •   Approved
  •   BASEC-NR 2015-00096, Kantonal Ethikkommission Zürich, Stampfenbachstrasse 121 8000 Zürich Schweiz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
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Interventions/Observational Groups

  •   The data basis for the quantitative part comprises data which are already collected during the regular inpatient treatment by the practitioner (psychologist or psychiatrist) and fed into a hospital-internal database. Time of measurement is the during entry period for inpatient treatment. Collected are the socio demographic data through of a clinical questionnaire, symptomdata using the symptom inventory Inventory®, Becks-Depression-Inventory®, health questionnaire SF-12® and the Impact of Events Scale - Revised. Patients who meet the criteria are during the inpatient treatment additionally diagnosed using the ICD-11 trauma questionnaire. Patients and relatives will be interviewed through a semi-structured interview on symptom management and their experience in everyday life.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   [---]*
  •   [---]*
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Primary Outcome

The socio demographic data through of a clinical questionnaire, symptomdata using the symptom inventory Inventory®, Becks-Depression-Inventory®, health questionnaire SF-12®, the Impact of Events Scale - Revised and through the ICD-11 trauma questionnaire.

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Secondary Outcome

The symptom management in the everyday life, the experience of the patients, as well as the experience of a corresponding relative are going to be collected through semi-structured interviews.

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/01/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Age between 18 - 65 years
• Diagnosis of a cPTSD
• Outpatient processing is not possible
• good good spoken knowledge of German
• Participation by relatives
• First inpatientreatment

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Exclusion Criteria

• acute or latent unrecognizable suicidality
• a main diagnosis other than cPTSD
• endangerment of self and others

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Addresses

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    • Integrierte Psychiatrie Winterthur
    • Wieshofstrasse 104
    • 8200  Winterthur
    • Switzerland
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • integrierte Psychiatrie Winterthur
    • Mr.  MSc  Manuel  Stadtmann 
    • Fulachstrasse 213
    • 8200  Schaffhausen
    • Switzerland
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    • integrierte Psychiatrie Winterthur
    • Mr.  MSc  Manuel  Stadtmann 
    • Fulachstrasse 213
    • 8200  Schaffhausen
    • Switzerland
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Sources of Monetary or Material Support

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    • Integrierte Psychiatrie Winterthur
    • Wieshofstrasse 104
    • 8400  Winterthur
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2017/12/31
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* This entry means the parameter is not applicable or has not been set.