Clinical trial NCT06575998: Insomnia in Primary Care
Official title: The Treatment of Insomnia in Primary Care: Evaluating and Improving Compliance to Clinical Practice Guidelines
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Primary Care
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The cluster randomization trial involves two randomization procedures. Firstly, on primary care practice level, practices will be randomized to intervention practice or control practice. Secondly, patients in the intervention practices will be randomized to pro-active identification or no identification. Pro-actively identified insomnia patients will be reported back to the PCP.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if training primary care providers on treatment of insomnia can improve insomnia symptoms in patients. Researchers will compare insomnia symptoms of patients receiving care from trained practices with patients receiving care from control practices (providing care-as-usual), to see if the training helps to provide improved insomnia care. Participants will be asked to complete four questionnaires and some participants will be invited for an insomnia consultation in primary care by their primary care providers (PCP).


Eligibility 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

Primary outcomes:
measure: Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)
timeFrame: From baseline to measurements at 2, 6 and 12 months
Secondary outcomes:
measure: Patient reported non-pharmacological 'sleep consultation'
timeFrame: 12 months after baseline questionnaire
measure: Report by the PCP of a non-pharmacological 'sleep consultation'
timeFrame: 12 months after baseline questionnaire
measure: Change in patient reported depression symptoms
timeFrame: From baseline to measurements at 2, 6 and 12 months
measure: Change in patient reported anxiety symptoms
timeFrame: From baseline to measurements at 2, 6 and 12 months
measure: Change in patient reported general health status
timeFrame: From baseline to measurements at 2, 6 and 12 months
measure: Change in report of sleep medication use
timeFrame: From baseline to measurements at 2, 6 and 12 months
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center (LUMC)
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center (LUMC)
name: Dennis O. Mook-Kanamori
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center (LUMC)
name: Rutger A. Middenburg
role: PRINCIPAL_INVESTIGATOR
affiliation: Leiden University Medical Center (LUMC)
name: Mattijs E. Numans
role: PRINCIPAL_INVESTIGATOR
References: