|- candidate number||6494|
|- NTR Number||NTR2019|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-sep-2009|
|- Secondary IDs||2009/089 METC Radboud University|
|- Public Title||Cognitive behavioral therapy given by primary health care workers (PMHCW) with patients with a sleepingdisorder.|
|- Scientific Title||The effectiveness of cognitive behavioral therapy given by primary health care workers with patients with a sleepingdisorder. |
|- hypothesis||Short-term cognitive behavioral therapy (CBT) given by primary health care workers with patients with chronic benzodiazepine use and new patients in the family practice with sleepinsdisorder, hypothised that CBT results in reduction of benzodiazepine prescription and improved sleeping behavior. |
|- Healt Condition(s) or Problem(s) studied||Sleep disorders|
|- Inclusion criteria||1. Patients with chronic benzodiazepine use;|
2. New patients who come to the general practitioner with sleepingdisorder.
|- Exclusion criteria||1. Current psychiatric treatment;|
2. Drug or alcohol dependency treatment;
3. Psychosis in medical history;
5. Terminal disease;
6. Do not speak the Dutch language;
7. Other criteria each individual general practitioner use .
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||25-sep-2009|
|- planned closingdate||25-mrt-2010|
|- Target number of participants||160|
|- Interventions||Patients with sleeping disorders (new episode or chronic benzodiazepine use) are invited to make use of CBT by primary health care worker. CBT includes 6 sessions and the use of a sleepdairy. The controle group receive usual care.|
|- Primary outcome||Benzodiazepine prescription.|
|- Secondary outcome||Outcomes related to the sleepingdisorder.|
|- Timepoints||Benzodiazepine prescription:|
Extraction from Electronic Medical System (HIS). Two times with a 6 months interval (sept. 2009 and march 2010).
Outcomes related to the sleepingdisorder:
Questionnaires two times with a 3 months interval for each patient (before and after CBT).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. G. Ven, van de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. G. Ven, van de|
|- Sponsor/Initiator ||Radboud University Scientific Institute for Quality of Healthcare|
(Source(s) of Monetary or Material Support)
|Stichting Robuust. Ondersteuning eerstelijns gezondheidszorg Zuid-Nederland|
|- Brief summary||Background: |
Cognitive behavioral therapy shows to be an effective way to treat patients with sleepingdisorder. In this study primairy health care workers are trained to use CBT with patients with sleepingdisorder.
Reduction of benzodiazepine prescription and improved sleeping behavior.
Extraction from Electronic Medical System (HIS) and questionnaires (before and after CBT).
Patients with sleeping disorders (new episode or chronic benzodiazepine use) are invited to make use of CBT by primary health care worker. CBT include 6 sessions and the use of a sleepdairy.
Results: not yet available.
Recruitment: the Netherlands.
|- Main changes (audit trail)|
|- RECORD||19-sep-2009 - 29-okt-2009|