Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
315 participants
INTERVENTIONAL
2024-09-12
2026-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Training with pro-active identification
For detailed description of the intervention, see the separate section on interventions.
Training
A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.
Pro-active identification
Pro-active identification of patients with clinical insomnia symptoms. Patients receiving care from the participating practices will be asked to fill-out the Insomnia Severity Index (ISI).The ISI is used to identify patients with clinical insomnia symptoms in the general practice. Trained practices will receive feedback on the ISI for half of the patients with clinical symptoms according to the ISI.
Training without pro-active identification
For detailed description of the intervention, see the separate section on interventions.
Training
A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.
Control
Care as usual according to national applicable primary guide guidelines.
No interventions assigned to this group
Interventions
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Training
A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.
Pro-active identification
Pro-active identification of patients with clinical insomnia symptoms. Patients receiving care from the participating practices will be asked to fill-out the Insomnia Severity Index (ISI).The ISI is used to identify patients with clinical insomnia symptoms in the general practice. Trained practices will receive feedback on the ISI for half of the patients with clinical symptoms according to the ISI.
Eligibility Criteria
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Inclusion Criteria
2. Survey confirmed presence of insomnia symptoms at least 3 times a week during at least the last 3 weeks AND
3. Survey shown increased score on the Insomnia Severity Index (ISI ≥ 11) AND
4. Survey shown interference with daily functioning on the Insomnia Severity Scale.
Exclusion Criteria
1. Shift work for individuals awakening outside the hours 4:00 A.M. and 10:00 A.M. or going to bed outside the hours of 8:00 P.M. and 2:00 A.M. more than twice a week
2. Other sleep-wake disorders including chronic obstructive sleep apnea, bruxism and narcolepsy, restless leg syndrome and parasomnia.
3. Current pregnancy
4. Presence of epilepsy, schizophrenia, bipolar disorder, post-traumatic stress disorder or dementia in medical history
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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menumans
Prof. dr. M.E. Numans
Principal Investigators
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Dennis O. Mook-Kanamori
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center (LUMC)
Rutger A. Middenburg
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center (LUMC)
Mattijs E. Numans
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center (LUMC)
Locations
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Leiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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80-83910-98-1158
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
N24.054
Identifier Type: -
Identifier Source: org_study_id