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Combined Cognitive-Behavioral and Pharmacological Continuation and Maintenance Treatment of Recurrent Depression
ISRCTN ISRCTN81212636
DOI 10.1186/ISRCTN81212636
ClinicalTrials.gov identifier
EudraCT number
Public title Combined Cognitive-Behavioral and Pharmacological Continuation and Maintenance Treatment of Recurrent Depression
Scientific title
Acronym CBCMT
Serial number at source DFG STA512/5-1
Study hypothesis To compare the long-term outcome of a cognitive-behavioral continuation or maintenance therapy versus manualized active psychoeducation

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.
Lay summary Not provided at time of registration
Ethics approval Approved by the Local Ethics Committee of the University Clinic of Jena, Germany
Study design Randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Recurrent depression
Participants - inclusion criteria 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 treatment
5. Age 18-70 years
Participants - exclusion criteria 1. Organic mental disorder
2. Psychological or behavioral disorders caused by psychotropic substances
3. Schizophrenia, schizoaffective disorder
4. Bipolar depression
5. 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
Anticipated start date 01/06/2006
Anticipated end date 31/05/2009
Status of trial Completed
Patient information material
Target number of participants 168
Interventions Cognitive-behavioral continuation or maintenance therapy versus manualized active psychoeducation
Primary outcome measure(s) Time to first relapse
Secondary outcome measure(s) Depression (Hamilton Rating Scale for Depression)
Sources of funding German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG)
Trial website
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23732968
Contact name Prof  Ulrich  Stangier
  Address Humboldt-Str. 11
  City/town Jena
  Zip/Postcode D-07743
  Country Germany
Sponsor University of Jena (Germany)
  Address Fürstengraben 1
  City/town Jena
  Zip/Postcode D-07743
  Country Germany
  Sponsor website: http://www.uni-jena.de/
Date applied 10/05/2006
Last edited 22/08/2013
Date ISRCTN assigned 26/05/2006
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