Treatment of chronically depressed patients: a multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) for chronic depressions versus usual secondary care.
BACKGROUND
'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) is a form of psychotherapy specifically developed for patients with chronic depression. In a study in the U.S., remarkable favorable effects of CBASP have been demonstrated. However, no other studies have as yet replicated these findings and CBASP has not been tested outside the United States. This protocol describes a randomized controlled trial on the effectiveness of CBASP in the Netherlands.


METHODS
The purpose of the present paper is to report the study protocol of a multisite randomized controlled trial testing the effectiveness of 'Cognitive Behavioral Analysis System of Psychotherapy' (CBASP) for chronic depression in the Netherlands. In this study, CBASP in combination with medication, will be tested versus usual secondary care in combination with medication. The aim is to recruit 160 patients from three mental health care organizations. Depressive symptoms will be assessed at baseline, after 8 weeks, 16 weeks, 32 weeks and 52 weeks, using the 28-item Inventory for Depressive Symptomatology (IDS). Effect modification by co morbid anxiety, alcohol consumption, general and social functioning and working alliance will be tested. GEE analyses of covariance, controlling for baseline value and center will be used to estimate the overall treatment effectiveness (difference in IDS score) at post-treatment and follow up. The primary analysis will be by 'intention to treat' using double sided tests. An economic analysis will compare the two groups in terms of mean costs and cost-effectiveness from a societal perspective.


CONCLUSIONS
The study will provide an answer to the question whether the favorable effects of CBASP can be replicated outside the US.


BACKGROUND
The Dutch Cochrane Center, NTR1090.
Wiersma
Jenneke E
JE
Department of Psychiatry and Institute for Research in Extramural Medicine, VU University Medical Center and Academic Outpatient Clinic for Affective Disorders, Stichting GGZBuitenamstel-de Geestgronden, The Netherlands. jennekew@ggzba.nl
van Schaik
Digna J F
DJ
van Oppen
Patricia
P
McCullough
James P
JP
Schoevers
Robert A
RA
Dekker
Jack J
JJ
Blom
Marc B J
MB
Maas
Kristel
K
Smit
Johannes H
JH
Penninx
Brenda W J H
BW
Beekman
Aartjan T F
AT
D000293:Adolescent; D000328:Adult; D000368:Aged; D002391:Catchment Area, Health; D002908:Chronic Disease; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003865:Major Depressive Disorder / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D016896:Treatment Outcome