Short-term cognitive behavioural therapy and short-term psychoanalytical supportive psychotherapy as treatment for depression: a randomised clinical trial
ISRCTN | ISRCTN31263312 |
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DOI | https://doi.org/10.1186/ISRCTN31263312 |
Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 04/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms E Driessen, MSc
Scientific
Scientific
Klaprozenweg 111
Amsterdam
1033 NN
Netherlands
Phone | +31 (0)20 590 5126 |
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ellen.driessen@mentrum.nl |
Study information
Study design | Randomised, parallel group, multicentre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | Praten & Pillen V |
Study objectives | A randomised clinical trial comparing the efficacy, efficiency and applicability of short-term cognitive behavioural therapy and short-term psychoanalytical supportive psychotherapy in the treatment of depressive disorders. |
Ethics approval(s) | Approval received from the Dutch council of medical-ethic boards for mental health institutes (Stichting Medisch-Etische Toetsingscommissie Instellingen Geestelijke Gezondheidszorg [METiGG]) on the 12th May 2006 (ref: 5236). |
Health condition(s) or problem(s) studied | Depressive disorders |
Intervention | 1. Mild to moderate depression (HDRS score 14 to 24): Short-term Cognitive Behavioral Therapy or Short-term Psychoanalytical Supportive Psychotherapy, 16 sessions of 45 minutes, during 22 weeks. 2. Severe depressive symptoms (HDRS score more than 24): Combination treatment: psychotherapy as mentioned above in combination with antidepressants. |
Intervention type | Other |
Primary outcome measure | Depressive complaints according to patient, therapist and independent rater at week 5, 10, 22 and 52. |
Secondary outcome measures | 1. Quality of life 2. Predictors of treatment outcome at week 22 and 52 |
Overall study start date | 01/04/2006 |
Completion date | 01/07/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 300 |
Key inclusion criteria | 1. Main diagnosis of: a. Major Depressive Episode b. Major Depressive Disorder c. Depressive Disorder not otherwise specified according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria 2. Hamilton Depression Rating Scale (HDRS) score more than 14 3. Age 18 to 65 4. Written informed consent |
Key exclusion criteria | 1. Bipolar Disorder 2. Depressive disorder with psychotic features 3. Suicide risk 4. Loss of impulse-control 5. Use of non-trial anti-depressants 6. Use of anti-psychotics or mood stabilisers 7. Substance abuse 8. Language problems 9. Contact with same Mentrum location within last six months |
Date of first enrolment | 01/04/2006 |
Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Klaprozenweg 111
Amsterdam
1033 NN
Netherlands
1033 NN
Netherlands
Sponsor information
Mentrum Mental Health Care Amsterdam (The Netherlands)
Research organisation
Research organisation
P.O. Box 75848
Amsterdam
1070 AV
Netherlands
Website | http://www.mentrum.nl/ |
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Funders
Funder type
Industry
Wyeth Pharmaceuticals (The Netherlands) - unrestricted grant
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/09/2013 | Yes | No |