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Cognitive behavioral therapy given by psychiatric nurse practitioners with patients with sleepingdisorder.


- candidate number6315
- NTR NumberNTR1954
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2009
- Secondary IDs Stichting Robuust
- Public TitleCognitive behavioral therapy given by psychiatric nurse practitioners with patients with sleepingdisorder.
- Scientific TitleCognitive behavioral therapy given by psychiatric nurse practitioners with patients with sleepingdisorder.
- ACRONYMN/A
- hypothesisStudy the effects of short-term cognitive behavioral therapy (CBT) given by psychiatric nurse practitioners with familiar patients with chronic benzodiazepine use and new patients in the family practice with sleepingdisorders.
- Healt Condition(s) or Problem(s) studiedSleep disorders
- Inclusion criteria1. Patients familiar with chronic benzodiazepine use;
2. New patients who come to the family practitioner with sleepingdisorders.
- Exclusion criteria1. Current psychiatric treatment;
2. Drug or alcohol dependency treatment;
3. Psychosis in medical history;
4. Epilepsy;
5. Terminal disease;
6. Not having mastered the Dutch language;
7. Individual family practitioners reasons severe comorbidity;
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-sep-2009
- planned closingdate25-mrt-2010
- Target number of participants62
- InterventionsInterventiongroup:
Patients in the interventiongroup receive a letter with an invitation to make use of the cognitive behavioral therapy. This include 5 sessions with the POH GGZ en the use of a sleepdiary and a sleepevaluation questionnaire.

The control group receive usual care of sleepdisorders. They don't receive a letter with an invitation and don't get the option of cognitive behavioral therapy and the use of a sleeping diary and sleep evaluation questionnaire. They do complete two times 4 questionnaires (see below) with an interval of 3 months.
- Primary outcomeBenzodiazepine use.
- Secondary outcomeOutcomes related to the sleepingdisorder.
- TimepointsBenzodiazepine gebruik:
Extraction from Electronic Medical System (HIS) (2 times with 3 months interval).

Outcomes related to the sleepingdisorder (2 times with 3 months interval):
1. Pittsburgh Sleep Quality Index (19 items);
2. Insomnia Severity Index (7 items);
3. Self-Efficacy Scale (9 items);
4. Houding en gedachten ten opzichte van de slaap (16 items);
5. Therapy Evaluation Questionnaire (7 items: only interventiongroup);
6. Slaapwaakkalender (only interventiongroup);
7. Slaapevaluatieformulier (6 items: only interventiongroup).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. G. Ven, van de
- CONTACT for SCIENTIFIC QUERIESDr. M.G.H. Laurant
- Sponsor/Initiator Stichting Robuust. Ondersteuning eerstelijns gezondheidszorg Zuid-Nederland
- Funding
(Source(s) of Monetary or Material Support)
Stichting Robuust. Ondersteuning eerstelijns gezondheidszorg Zuid-Nederland
- PublicationsN/A
- Brief summaryStudy the effects of short-term cognitive behavioral therapy (CBT) given by psychiatric nurse practitioners with familiar patients with chronic benzodiazepine use and new patients in the family practice with sleepingdisorders.
- Main changes (audit trail)
- RECORD12-aug-2009 - 11-okt-2009


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