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: |
DRKS00009874 |
Date of registration:
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29/01/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Brief inpatient treatment continued by videoconference based psychotherapy for patients with chronic major depression
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Scientific title:
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Brief inpatient treatment continued by videoconference based psychotherapy for patients with chronic major depression - CBASP-VCP |
Date of first enrolment:
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06/10/2015 |
Target sample size:
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30 |
Recruitment status: |
Recruiting stopped after recruiting started |
URL:
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http://drks.de/search/en/trial/DRKS00009874 |
Study type:
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interventional |
Study design:
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Allocation: Non-randomized controlled study; Masking: Open (masking not used); Control: historical; Assignment: other; Study design purpose:
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Nicole
Ower |
Address:
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Hauptstr. 5
79104
Freiburg
Germany |
Telephone:
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0761-27069841 |
Email:
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Nicole.ower@uniklinik-freiburg.de |
Affiliation:
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Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie |
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Name:
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Nicole
Ower |
Address:
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Hauptstr. 5
79104
Freiburg
Germany |
Telephone:
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0761-27069841 |
Email:
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Nicole.ower@uniklinik-freiburg.de |
Affiliation:
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Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie |
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Key inclusion & exclusion criteria
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Inclusion criteria: - diagnosis of Chronic Depression - Hamilton Rating Scale of Depression (HRSD-24) score>20 - in ongoing medical/psychiatric care - age 18-70 years - fluent in German language - technical requirements (Internet access) - informed consent - treatment resistance (no response to two or more adequate trials of antidepressants and/or no response to at least two health-insurance-reimbursed psychotherapies with at least 22 sessions each).
Exclusion criteria: - history of bipolar disorder - substance addiction (less than 3 months clean) - antisocial or borderline personality disorder - severe autism - organic brain disorders - severe physical illness - acute risk of suicide or suicide attempt within the last 12 months
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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major chronic depression F33
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Recurrent depressive disorder
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Intervention(s)
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Group 1: Intervetniongroup: 3 weeks inpatient CBASP treatment (2 single therapy sessions of 50 min per week) with following videoconference based outpatient CBASP treatment for 9 weeks (2 single therapy sessions of 50 min per week).
Group 2: Historical comparison group from existing data of patients who participated in a classical 12 weeks inpatient CBASP treatment (2 single therapy sessions of 50 min per week plus 2 h of CBASP-group therapy per week) .
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Primary Outcome(s)
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- Questionnaire on feasibility and acceptance. Completed by patients and therapists - Hamilton Rating Scale for Depression (HAMD-24; Hamilton, 1960) T0, T1, T2, T3 (T0 : at admission to station , T1 : at discharge from station , T2 : at end of outpatient therapy , follow-up ( T3 ) : 3 months after completion of outpatient therapy (end of study)
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Secondary Outcome(s)
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- Structured Clinical Interview for DSM-IV Disorders (T0). - Childhood Trauma Questionnaire (T0). - Beck Depression Inventory (T0-T3). - Clinical Global Impression Scale (T1-T2). - Global Assessment of Functioning Scale (T1-T2). - World Health Organization Quality of Life Instrument (T0-T3). - Impact Message Inventory-R (therapist-patient-relationship) (T1-T2).
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Source(s) of Monetary Support
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Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie
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Ministerium für Wissenschaft, Fortschung und Kunst Baden-Württemberg
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Ethics review
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Status: Approved
Approval date: 18/08/2015
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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