Short-term cognitive behavioural therapy and short-term psychoanalytical supportive psychotherapy as treatment for depression: a randomised clinical trial

ISRCTN ISRCTN31263312
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

Klaprozenweg 111
Amsterdam
1033 NN
Netherlands

Phone +31 (0)20 590 5126
Email ellen.driessen@mentrum.nl

Study information

Study designRandomised, parallel group, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymPraten & Pillen V
Study objectivesA 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) studiedDepressive disorders
Intervention1. 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 typeOther
Primary outcome measureDepressive complaints according to patient, therapist and independent rater at week 5, 10, 22 and 52.
Secondary outcome measures1. Quality of life
2. Predictors of treatment outcome at week 22 and 52
Overall study start date01/04/2006
Completion date01/07/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants300
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2006
Date of final enrolment01/07/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Klaprozenweg 111
Amsterdam
1033 NN
Netherlands

Sponsor information

Mentrum Mental Health Care Amsterdam (The Netherlands)
Research organisation

P.O. Box 75848
Amsterdam
1070 AV
Netherlands

Website http://www.mentrum.nl/

Funders

Funder type

Industry

Wyeth Pharmaceuticals (The Netherlands) - unrestricted grant

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 01/09/2013 Yes No