Insomnia in Primary Care

The Treatment of Insomnia in Primary Care: Evaluating and Improving Compliance to Clinical Practice Guidelines

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).

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Other: Training; Other: Pro-active identification

• Study Type: Interventional
• Enrollment (Actual): 485
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • South Holland
    • Leiden, South Holland, Netherlands, 2333ZA
      • Leiden University Medical Center (LUMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training with pro-active identification; For detailed description of the intervention, see the separate section on interventions.	Other: Training; A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.; Other: 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.
Experimental: Training without pro-active identification; For detailed description of the intervention, see the separate section on interventions.	Other: Training; A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.
No Intervention: Control; Care as usual according to national applicable primary guide guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)	Change is measured linearly using the Insomnia Severity Index. Scores range from 0 to 28 points in which higher scores represent a worse outcome. Secondly, the categorically defined treatment response is established 2 months after baseline questionnaire (remission = ISI score < 11, ISI score reduction ≥ 8).	From baseline to measurements at 2, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported non-pharmacological 'sleep consultation'	Patient report of a sleep consultation (survey answer yes/no) combined with patient reported sleep medication use (survey answer yes/no).	12 months after baseline questionnaire
Report by the PCP of a non-pharmacological 'sleep consultation'	PCP reported sleep consultation (survey answer yes/no) combined with PCP reported sleep medication use (survey answer yes/no).	12 months after baseline questionnaire
Change in patient reported depression symptoms	Measured linearly using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27 points in which higher scores represent a worse outcome.	From baseline to measurements at 2, 6 and 12 months
Change in patient reported anxiety symptoms	Measured linearly using the General Anxiety Disorder Questionniare (GAD-7). Scores range from 0 to 21 points in which higher scores represent a worse outcome.	From baseline to measurements at 2, 6 and 12 months
Change in patient reported general health status	Measured with the Short Form-36 questionnaire (SF-36). Scores represent the percentage of total possible score achieved, ranging from 0 to 100. A higher score represents a better outcome.	From baseline to measurements at 2, 6 and 12 months
Change in report of sleep medication use	Patient reported use of sleep medication in the past two weeks (survey answer yes/no).	From baseline to measurements at 2, 6 and 12 months

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Dennis O. Mook-Kanamori, Leiden University Medical Center (LUMC); Principal Investigator: Rutger A. Middenburg, Leiden University Medical Center (LUMC); Principal Investigator: Mattijs E. Numans, Leiden University Medical Center (LUMC)

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Actual): March 13, 2026
• Study Completion (Actual): March 13, 2026

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Primary Care
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: N24.054; 80-83910-98-1158 (Other Grant/Funding Number: ZonMw)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to the nature of the study blinding is not possible. Therefore, the data contains privacy sensitive information and only restricted access may be granted for unidentifiable parts of the data. It has yet to be decided which data can be acquired through restricted access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No