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Guided online intervention for patients with insomnia


- candidate number21966
- NTR NumberNTR5202
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-apr-2015
- Secondary IDsABR 51849 
- Public TitleGuided online intervention for patients with insomnia
- Scientific Title(Cost-)effectiveness of a guided online CBT intervention in comparison to care-as-usual for patients with insomnia in general practice
- ACRONYM
- hypothesisThe guided online CBT intervention is expected to show favorable effects and to be cost-effective in comparison to care-as-usual for patients with insomnia in general practice
- Healt Condition(s) or Problem(s) studiedInsomnia, Insomnia
- Inclusion criteria- diagnosis of insomnia (DSM5)
- >18 years of age
- Dutch proficiency
- access to a computer and the internet
- Exclusion criteria- presence of sleep apnea
- patients working night shifts
- preganancy or breast feeding
- current suicidal ideation
- current psychosis
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-dec-2018
- Target number of participants160
- Interventionsonline course based on cognitive behavioral therapy for insomnia
- Primary outcomeinsomnia severity index
- Secondary outcomeSecondary objectives include investigation of cost-effectiveness. Several variables will be included as potential moderators and mediators of treatment effects, e.g. age, medication use, duration of the sleep problem, and alcohol use.
- Timepointsbaseline (t0), post-intervention (t0+8 weeks), follow-up 1 (to+6 months), follow-up 2 (t0+12 months)
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES T van der Zweerde
- CONTACT for SCIENTIFIC QUERIES T van der Zweerde
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications-
- Brief summaryIn the Netherlands, most patients that refer to their GPs with sleeping problems receive medication. Behavioral interventions (psycho-education, cognitive behavioral therapy) are known to be more effective, but are not often offered. The present proposal is focussed around a online course (6 weeks) aimed at treating insomnia.
- Main changes (audit trail)
- RECORD17-apr-2015 - 25-jul-2015


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