Condition category
Mental and Behavioural Disorders
Date applied
10/05/2006
Date assigned
26/05/2006
Last edited
22/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulrich Stangier

ORCID ID

Contact details

Humboldt-Str. 11
Jena
D-07743
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DFG STA512/5-1

Study information

Scientific title

Acronym

CBCMT

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.

Ethics approval

Approved by the Local Ethics Committee of the University Clinic of Jena, Germany

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Recurrent depression

Intervention

Cognitive-behavioral continuation or maintenance therapy versus manualized active psychoeducation

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Time to first relapse

Secondary outcome measures

Depression (Hamilton Rating Scale for Depression)

Overall trial start date

01/06/2006

Overall trial end date

31/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

168

Participant 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

Recruitment start date

01/06/2006

Recruitment end date

31/05/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Humboldt-Str. 11
Jena
D-07743
Germany

Sponsor information

Organisation

University of Jena (Germany)

Sponsor details

Fürstengraben 1
Jena
D-07743
Germany

Sponsor type

University/education

Website

http://www.uni-jena.de/

Funders

Funder type

Research organisation

Funder name

German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23732968

Publication citations

  1. Results

    Stangier U, Hilling C, Heidenreich T, Risch AK, Barocka A, Schlösser R, Kronfeld K, Ruckes C, Berger H, Röschke J, Weck F, Volk S, Hambrecht M, Serfling R, Erkwoh R, Stirn A, Sobanski T, Hautzinger M, Maintenance cognitive-behavioral therapy and manualized psychoeducation in the treatment of recurrent depression: a multicenter prospective randomized controlled trial., Am J Psychiatry, 2013, 170, 6, 624-632, doi: 10.1176/appi.ajp.2013.12060734.

Additional files

Editorial Notes