Training primary care providers to improve insomnia treatment
The Treatment of Insomnia in Primary Care: Evaluating and Improving Compliance to Clinical Practice Guidelines
This study tests if training primary care providers on how to treat insomnia can help patients feel better compared to those who get standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 315 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, Zuid-Holland) |
| Trial ID | NCT06575998 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether training primary care providers on the treatment of insomnia can lead to better management of insomnia symptoms in patients. Researchers will compare the insomnia symptoms of patients receiving care from trained practices against those from control practices that provide standard care. Participants will complete four questionnaires, and some may receive an insomnia consultation from their primary care providers. The study focuses on enhancing the quality of insomnia care in primary care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are patients registered with a participating primary care facility who experience insomnia symptoms at least three times a week.
Not a fit: Patients with other sleep-wake disorders or significant mental health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved insomnia management and better quality of life for patients suffering from insomnia.
How similar studies have performed: Other studies have shown that training primary care providers can enhance patient care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for a patient to be eligible to participate in this study: 1. Patient registered with a participating primary care facility and willing to provide informed consent AND 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: Patients meeting any of the following criteria in the survey will be excluded from participation in this study: 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
Where this trial is running
Leiden, Zuid-Holland
- Leiden University Medical Center (LUMC) — Leiden, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Dennis O. Mook-Kanamori — Leiden University Medical Center (LUMC)
- Study coordinator: Maria C.N. Meijer
- Email: m.c.n.meijer@lumc.nl
- Phone: 0031 71 526 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.