Combined Cognitive-Behavioral and Pharmacological Continuation and Maintenance Treatment of Recurrent Depression
| ISRCTN | ISRCTN81212636 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81212636 |
| Protocol serial number | DFG STA512/5-1 |
| Sponsor | University of Jena (Germany) |
| Funder | German Research Foundation (Deutsche Forschungsgemeinsschaft) (DFG) |
- 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
Scientific
Humboldt-Str. 11
Jena
D-07743
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CBCMT |
| Study objectives | 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(s) | Approved by the Local Ethics Committee of the University Clinic of Jena, Germany |
| Health condition(s) or problem(s) studied | Recurrent depression |
| Intervention | Cognitive-behavioral continuation or maintenance therapy versus manualized active psychoeducation |
| Intervention type | Other |
| Primary outcome measure(s) |
Time to first relapse |
| Key secondary outcome measure(s) |
Depression (Hamilton Rating Scale for Depression) |
| Completion date | 31/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 168 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/05/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Humboldt-Str. 11
Jena
D-07743
Germany
D-07743
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
