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ISRCTN
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ISRCTN81212636
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ClinicalTrials.gov identifier
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Public title
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Combined Cognitive-Behavioral and Pharmacological Continuation and Maintenance Treatment of Recurrent Depression
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Scientific title
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Acronym
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CBCMT
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Serial number at source
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DFG STA512/5-1
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Study hypothesis
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To compare the long-term outcome of a cognitive-behavioral continuation or maintenance therapy versus manualized active psychoeducation
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Ethics approval
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Approved by the Local Ethics Committee of the University Clinic of Jena, Germany
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Study design
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Parallel group design with two treatment groups. After a two month run-in period, patients will be randomized to either treatment group. Therapists will be unblinded with regards to allocations of treatment groups. Blinded independent raters will assess outcome criteria after the eight-month treatment phase and then every three months up to one-year follow-up.
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Recurrent depression
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Participants - inclusion criteria
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1. Diagnosis of recurrent depressive disorder (>3 major depressive episodes [MDE]), currently in remission (ICD-10 F33.4)2. Complete remission over 8 weeks after acute treatment of MDE
3. At least one index depressive episode within 12 months prior to the treatment
4. Hamilton Rating Scale for Depression (HRSD-17) score of 9 or less over 8 weeks prior to treatment5. Age 18-70 years
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Participants - exclusion criteria
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1. Organic mental disorder2. Psychological or behavioral disorders caused by psychotropic substances
3. Schizophrenia, schizoaffective disorder
4. Bipolar depression5. Adjustment disorders
6. Borderline personality disorder
7. Mental retardation
8. Acute suicidality
9. Severe co-morbid medical condition
10. More than five individual sessions of regular cognitive-behavioral treatment within one year before randomization
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Anticipated start date
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01/06/2006
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Anticipated end date
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31/05/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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168
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Interventions
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Cognitive-behavioral continuation or maintenance therapy versus manualized active psychoeducation
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Primary outcome measure(s)
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Time to first relapse
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Secondary outcome measure(s)
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Depression (Hamilton Rating Scale for Depression)
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Sources of funding
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German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG)
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Trial website
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Publications
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Contact name
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Prof
Ulrich
Stangier
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Address
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Humboldt-Str. 11
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City/town
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Jena
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Zip/Postcode
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D-07743
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Country
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Germany
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Sponsor
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University of Jena (Germany)
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Address
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Fürstengraben 1
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City/town
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Jena
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Zip/Postcode
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D-07743
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Country
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Germany
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Sponsor website:
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http://www.uni-jena.de/
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Date applied
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10/05/2006
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Last edited
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26/05/2006
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Date ISRCTN assigned
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26/05/2006
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