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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 8 April 2024
Main ID:  DRKS00012268
Date of registration: 21/04/2017
Prospective Registration: No
Primary sponsor: Integrierte Psychiatrie Winterthur
Public title: Symptom management in complex post-traumatic stress disorder, view and experience of patients and their relatives: A mixed methods approach
Scientific title: Symptom management in complex post-traumatic stress disorder, view and experience of patients and their relatives: A mixed methods approach
Date of first enrolment: 01/01/2017
Target sample size: 100
Recruitment status: Complete
URL:  http://drks.de/search/en/trial/DRKS00012268
Study type:  observational
Study design:  Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: supportive care  
Phase: 
Countries of recruitment
Switzerland
Contacts
Name: Manuel    Stadtmann
Address:  Fulachstrasse 213 8200 Schaffhausen Switzerland
Telephone: 0041798196834
Email: manuel.stadtmann@uni-wh.de
Affiliation:  integrierte Psychiatrie Winterthur
Name: Manuel    Stadtmann
Address:  Fulachstrasse 213 8200 Schaffhausen Switzerland
Telephone: 0041798196834
Email: manuel.stadtmann@uni-wh.de
Affiliation:  integrierte Psychiatrie Winterthur
Key inclusion & exclusion criteria
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

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


Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Post-traumatic stress disorder

F43.1
F43.1
Intervention(s)
Group 1: 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.
Primary Outcome(s)
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.
Secondary Outcome(s)
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.
Secondary ID(s)
Source(s) of Monetary Support
Integrierte Psychiatrie Winterthur
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 26/02/2016
Contact:
Kantonale Ethikkommission Zürich [Kantonal Ethikkommission Zürich, Stampfenbachstrasse 121 8000 Zürich Schweiz]
Results
Results available:
Date Posted:
Date Completed: 31/12/2017
URL: http://drks.de/search/en/trial/DRKS00012268#studyResults
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