Contact information
Type
Scientific
Primary contact
Ms E Driessen, MSc
ORCID ID
Contact details
Klaprozenweg 111
Amsterdam
1033 NN
Netherlands
+31 (0)20 590 5126
ellen.driessen@mentrum.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Praten & Pillen V
Study hypothesis
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
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).
Study design
Randomised, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/04/2006
Overall trial end date
01/07/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
300
Participant 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
Recruitment start date
01/04/2006
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Klaprozenweg 111
Amsterdam
1033 NN
Netherlands
Sponsor information
Organisation
Mentrum Mental Health Care Amsterdam (The Netherlands)
Sponsor details
P.O. Box 75848
Amsterdam
1070 AV
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Wyeth Pharmaceuticals (The Netherlands) - unrestricted grant
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24030613
Publication citations
-
Results
Driessen E, Van HL, Don FJ, Peen J, Kool S, Westra D, Hendriksen M, Schoevers RA, Cuijpers P, Twisk JW, Dekker JJ, The efficacy of cognitive-behavioral therapy and psychodynamic therapy in the outpatient treatment of major depression: a randomized clinical trial., Am J Psychiatry, 2013, 170, 9, 1041-1050, doi: 10.1176/appi.ajp.2013.12070899.