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Completed

NCT Number: NCT06575998

Insomnia in Primary Care

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).

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333ZA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for a patient to be eligible to participate in this study:

  • Patient registered with a participating primary care facility and willing to provide informed consent AND
  • Survey confirmed presence of insomnia symptoms at least 3 times a week during at least the last 3 weeks AND
  • Survey shown increased score on the Insomnia Severity Index (ISI ≥ 11) AND
  • 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:

  • 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
  • Other sleep-wake disorders including chronic obstructive sleep apnea, bruxism and narcolepsy, restless leg syndrome and parasomnia.
  • Current pregnancy
  • Presence of epilepsy, schizophrenia, bipolar disorder, post-traumatic stress disorder or dementia in medical history

Treatment and study plan

Training

Other

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

Other

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.

Primary outcomes

  1. Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)

    Time frame: From baseline to measurements at 2, 6 and 12 months

    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).

Secondary outcomes

  1. Patient reported non-pharmacological 'sleep consultation'

    Time frame: 12 months after baseline questionnaire

    Patient report of a sleep consultation (survey answer yes/no) combined with patient reported sleep medication use (survey answer yes/no).

  2. Report by the PCP of a non-pharmacological 'sleep consultation'

    Time frame: 12 months after baseline questionnaire

    PCP reported sleep consultation (survey answer yes/no) combined with PCP reported sleep medication use (survey answer yes/no).

  3. Change in patient reported depression symptoms

    Time frame: From baseline to measurements at 2, 6 and 12 months

    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.

  4. Change in patient reported anxiety symptoms

    Time frame: From baseline to measurements at 2, 6 and 12 months

    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.

  5. Change in patient reported general health status

    Time frame: From baseline to measurements at 2, 6 and 12 months

    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.

  6. Change in report of sleep medication use

    Time frame: From baseline to measurements at 2, 6 and 12 months

    Patient reported use of sleep medication in the past two weeks (survey answer yes/no).

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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