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
Protocol serial number	N/A
Sponsor	Mentrum Mental Health Care Amsterdam (The Netherlands)
Funder	Wyeth Pharmaceuticals (The Netherlands) - unrestricted grant

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms E Driessen, MSc
Scientific

Klaprozenweg 111
Amsterdam
1033 NN
Netherlands

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

Primary study design	Interventional
Study design	Randomised, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
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(s)	Depressive complaints according to patient, therapist and independent rater at week 5, 10, 22 and 52.
Key secondary outcome measure(s)	1. Quality of life 2. Predictors of treatment outcome at week 22 and 52
Completion date	01/07/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Klaprozenweg 111

Amsterdam
1033 NN
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No