Trial document
This trial has been registered retrospectively.
DRKS00003690
Trial Description
Title
Euthymic Therapy: a Randomised Controlled Trial
Trial Acronym
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URL of the Trial
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Brief Summary in Lay Language
Investigation of a cognitive behavioural resource-strengthening group intervention program which aims to increase hedonic experiences such as joy and happiness. We hope to find a comparable effect in treatment of patients with remaining depression symptoms.
Brief Summary in Scientific Language
Evaluation of a patient's ressource srengthening psychotherapeutic intervention in treatment of residual depression symptoms
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00003690
- 2012/04/02
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- yes
- Approved
- EA1/172/06, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
Secondary IDs
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Health Condition or Problem studied
- F32 - Depressive episode
- F33 - Recurrent depressive disorder
Interventions/Observational Groups
- Euthymic therapy, group intervention, 7 weekly sessions à 50 min
- psychoeducation, group therapy, 7 weekly sessions à 50 min
Characteristics
- Interventional
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- Randomized controlled trial
- Double or multiple blind
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- Active control
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
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
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).
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2007/10/24
- 44
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Diagnosis of depression (ICD-10: F32, F33) partialremission (HAMD-21 depression score of </= 9) or a reduction of depression severity by 50% (HAMD) from the peak during inpatient treatment. Psychiatric treatment as usual remained, and it was ensured that no change in medication occurred within two weeks prior to the start of the group intervention.
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).
Addresses
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- Charité Campus Charité Mitte
- Charitéplatz 1
- 10117 Berlin
- Germany
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- http://www.charite.de
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- Charité Campus Charité Mitte
- Ms. Dipl.-Psych. Julia Kiermeir
- Charitéplatz 1
- 10117 Berlin
- Germany
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- julia.kiermeir at charite.de
- http://www.charite.de
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start of 1:1-Block address public-contact
- Charité Campus Charité Mitte
- Ms. Dipl.-Psych. Julia Kiermeir
- Charitéplatz 1
- 10117 Berlin
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 030450517203
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- julia.kiermeir at charite.de
- http://www.charite.de
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Sources of Monetary or Material Support
-
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- Charité Campus Charité Mitte
- Charitéplatz 1
- 10117 Berlin
- Germany
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- http://www.charite.de
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Status
- Recruiting complete, follow-up complete
- 2009/05/15
Trial Publications, Results and other Documents
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