|- candidate number||1585|
|- NTR Number||NTR375|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||OG 00-028 |
|- Public Title||Cognitive Self-therapy (CST) for patients with chronic-recurrent depression or anxiety.|
|- Scientific Title||Cognitive Self-therapy (CST) for patients with chronic-recurrent depression or anxiety.|
|- hypothesis||Does Cognitive Self-therapy (CST) in outpatient mental health care has any superiority as to cost-effectiveness and outcome compared to treatment as usual?|
|- Healt Condition(s) or Problem(s) studied||Depression, Anxiety disorders|
|- Inclusion criteria||1. DSM IV diagnosis of chronic and/or recurrent depression, dysthemic disorder or (generalised) anxiety disorder; |
2. Duration of symptoms more than 2 years;
3. 18-65 years.
|- Exclusion criteria||1. Suicidal behaviour; |
3. Substance dependency;
4. IQ < 85;
5. Lack of insight in personal vulnerability in social contacts or relationship.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2000|
|- planned closingdate||1-dec-2004|
|- Target number of participants||151|
|- Interventions||Treatment as usual (TAU) versus CST which is a structured method that seeks to restructure cognitive schemata by focusing on problems in social functioning and relationships and consists of a Preparatory Phase, 2) an Orientation Course of three weekly morning-meetings to practice with peers; a Basic Course of 5 weekly, day-long sessions in which patients learn to manage self-therapy sessions with peers.|
Those who perform these sessions adequately are certified to participate in weekly meetings, now led by peers in accordance with the manual, as taught during the BC.
The patients’ role in the treatment gradually evolves into that of “paraprofessionals,” such that finally they conduct Self-Therapy sessions in reciprocal relationships with peers.
|- Primary outcome||Symptoms of anxiety and depression (SCL-90; BDI; ZBV).|
|- Secondary outcome||1. Quality of life; |
2. Social functioning;
3. WHO Qol;
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. D. Wiersma|
|- CONTACT for SCIENTIFIC QUERIES||Drs. P.C.A.M. Boer, den|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, University Medical Center Groningen (UMCG)|
|- Publications||1. den Boer, P. C. A. M., Mersch, P. P. A., and Wiersma, D. (2004) Cognitieve zelftherapie. Verslag van een pilot-studie naar een alternatieve behandeling voor psychiatrische patiënten. Maandblad Geestelijke volksgezondheid, 59, 325-338.|
2. den Boer, P. C. A. M., Wiersma, D., and van den Bosch, R. (2004b) Why is self-help neglected in the treatment of emotional disorders? A meta-analysis. Psychological medicine, 34, 959-972.
3. Boer PCAM den, Bosch RJ van den, Vaarwerk I ten, Stant AD, Wiersma D. Cognitive Self-Therapy in chronic and remittent emotional disorders is effective and reduces therapist contact: a multi-center randomized controlled trial. Brit J Psychiatry in press.
|- Brief summary||Both treatment conditions showed significant improvements on symptom measures but did not differ between each other as to the main outcome SCL-90. CST patients improved more in some aspects of life satisfaction (e.g., feelings of safety, finance, recreation, transport; WHO-Qol, environmental sub-scale), and in social functioning in relationships with parents and siblings. |
They also had significantly fewer contacts with other therapists (non-psychiatrists) than TAU patients. None of the patients committed suicide.
No variables were predictive for a good outcome.
CST patients appeared to rely more on their own experiences while TAU relied more on the judgement of other people.
The higher initial costs for the CST condition were compensated by considerably lower costs during follow-up.
|- Main changes (audit trail)|
|- RECORD||12-sep-2005 - 16-jun-2008|