|
Main
|
|
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: |
DRKS00003690 |
|
Date of registration:
|
02/04/2012 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Euthymic Therapy: a Randomised Controlled Trial
|
|
Scientific title:
|
Euthymic Therapy: a Randomised Controlled Trial |
|
Date of first enrolment:
|
24/10/2007 |
|
Target sample size:
|
44 |
|
Recruitment status: |
Complete |
|
URL:
|
http://drks.de/search/en/trial/DRKS00003690 |
|
Study type:
|
interventional |
|
Study design:
|
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Germany
| | | | | | | |
|
Contacts
|
|
Name:
|
Julia
Kiermeir |
|
Address:
|
Charitéplatz 1
10117
Berlin
Germany |
|
Telephone:
|
030450517203 |
|
Email:
|
julia.kiermeir@charite.de |
|
Affiliation:
|
Charité Campus Charité Mitte |
|
|
Name:
|
Julia
Kiermeir |
|
Address:
|
Charitéplatz 1
10117
Berlin
Germany |
|
Telephone:
|
030450517203 |
|
Email:
|
julia.kiermeir@charite.de |
|
Affiliation:
|
Charité Campus Charité Mitte |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Diagnosis of depression (ICD-10: F32, F33) partialremission (HAMD-21 depression score of
Exclusion criteria: History of bipolar disorder, cyclothymia, schizophrenia, schizoaffective disorder, organic brain damage or substance abuse/dependence. Participation in a pharmaceutical study and ongoing individual psychotherapy were further exclusion criteria as well as borderline (ICD-10: F60.3) or antisocial personality disorders (ICD-10: F60.2).
Age minimum:
18 Years
Age maximum:
None
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Recurrent depressive disorder
|
F32
F33
|
|
Depressive episode
|
|
Intervention(s)
|
Group 1: Euthymic therapy, group intervention, 7 weekly sessions à 50 min
Group 2: psychoeducation, group therapy, 7 weekly sessions à 50 min
|
|
Primary Outcome(s)
|
Our project thus aimes to assess the effects of ET on reduction of depressive symptoms (HAMD-21, BDI), anhedonia (TAF) and a patient's health resources (MR FSF) in a randomized, controlled, parallel-group design. We expect ET to reduce depressive residual symptoms and anhedonia and improve self care as effectively as the validated reference treatment (psychoeducation). 3 measuring times: baseline, post intervention an follow-up (after 3 month).
Following questionaires were used:
•Hamilton Depression Scale (HAMD)
•Tübinger-Anhedonie-Fragebogen (TAF)
•Becks Depressions Inventar (BDI II)
•Marburger Skalen zur Selbstfürsorge (MR FSF)
|
|
Secondary Outcome(s)
|
Additionally we expect an increase in following parameters: leisure activities (Checkliste der Freizeitaktivitäten, CFA), liefe-satisfaction (Lebenszufriedenheitsbogen, LZF), pleasure (Genussfragebogen, SFS), general state of health (Fragebogen zum allg. Gesundheitszustand), SF-36), self-efficacy (Fragebogen zum Selbstwirksamkeitserleben, SWE), locus of control (Fragebogen zur Erhebung von Kontrollüberzeugungen zu Krankheit und Gesundheit, KKG), sense of coherence (Marburger Skalen zum Kohärenzsinn, MR SOC).
3 measuring times: baseline, post intervention an follow-up (after 3 month).
|
|
Source(s) of Monetary Support
|
|
Charité Campus Charité Mitte
|
|
Ethics review
|
Status: Approved
Approval date: 05/12/2006
Contact:
ethikkommission@charite.de
Ethikkommission der Charité – Universitätsmedizin Berlin
(+49)30-450517222
ethikkommission@charite.de
|
|