Combined Cognitive-Behavioral and Pharmacological Continuation and Maintenance Treatment of Recurrent Depression

ISRCTN ISRCTN81212636
DOI https://doi.org/10.1186/ISRCTN81212636
Secondary identifying numbers DFG STA512/5-1
Submission date
10/05/2006
Registration date
26/05/2006
Last edited
22/08/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ulrich Stangier
Scientific

Humboldt-Str. 11
Jena
D-07743
Germany

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymCBCMT
Study objectivesTo 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.
Ethics approval(s)Approved by the Local Ethics Committee of the University Clinic of Jena, Germany
Health condition(s) or problem(s) studiedRecurrent depression
InterventionCognitive-behavioral continuation or maintenance therapy versus manualized active psychoeducation
Intervention typeOther
Primary outcome measureTime to first relapse
Secondary outcome measuresDepression (Hamilton Rating Scale for Depression)
Overall study start date01/06/2006
Completion date31/05/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants168
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2006
Date of final enrolment31/05/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

Humboldt-Str. 11
Jena
D-07743
Germany

Sponsor information

University of Jena (Germany)
University/education

Fürstengraben 1
Jena
D-07743
Germany

http://www.uni-jena.de/
ROR logo https://ror.org/05qpz1x62

Funders

Funder type

Research organisation

German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2013 Yes No
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