Main
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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:
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German Clinical Trials Register |
Last refreshed on:
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8 April 2024 |
Main ID: |
DRKS00012268 |
Date of registration:
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21/04/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Symptom management in complex post-traumatic stress disorder, view and experience of patients and their relatives: A mixed methods approach
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Scientific title:
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Symptom management in complex post-traumatic stress disorder, view and experience of patients and their relatives: A mixed methods approach |
Date of first enrolment:
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01/01/2017 |
Target sample size:
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100 |
Recruitment status: |
Complete |
URL:
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http://drks.de/search/en/trial/DRKS00012268 |
Study type:
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observational |
Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: supportive care
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Phase:
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Manuel
Stadtmann |
Address:
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Fulachstrasse 213
8200
Schaffhausen
Switzerland |
Telephone:
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0041798196834 |
Email:
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manuel.stadtmann@uni-wh.de |
Affiliation:
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integrierte Psychiatrie Winterthur |
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Name:
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Manuel
Stadtmann |
Address:
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Fulachstrasse 213
8200
Schaffhausen
Switzerland |
Telephone:
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0041798196834 |
Email:
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manuel.stadtmann@uni-wh.de |
Affiliation:
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integrierte Psychiatrie Winterthur |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Post-traumatic stress disorder
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F43.1
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F43.1
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Intervention(s)
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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.
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Primary Outcome(s)
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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(s)
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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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Source(s) of Monetary Support
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Integrierte Psychiatrie Winterthur
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Ethics review
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Status: Approved
Approval date: 26/02/2016
Contact:
Kantonale Ethikkommission Zürich [Kantonal Ethikkommission Zürich,
Stampfenbachstrasse 121
8000 Zürich
Schweiz]
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