Insomnia in Primary Care

NCT06575998 | Completed

• 2 other identifiers: N24.05480-83910-98-1158
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia

Keywords

Primary Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient reported non-pharmacological 'sleep consultation'

  12 months after baseline questionnaire

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

  12 months after baseline questionnaire

• Change in patient reported depression symptoms

  From baseline to measurements at 2, 6 and 12 months

• Change in patient reported anxiety symptoms

  From baseline to measurements at 2, 6 and 12 months

• Change in patient reported general health status

  From baseline to measurements at 2, 6 and 12 months

Study Arms (3)

Training with pro-active identification

EXPERIMENTAL

For detailed description of the intervention, see the separate section on interventions.

Other: Training; Other: Pro-active identification

Training without pro-active identification

EXPERIMENTAL

For detailed description of the intervention, see the separate section on interventions.

Other: Training

Control

NO INTERVENTION

Care as usual according to national applicable primary guide guidelines.

Interventions

Training OTHER

A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.

Training with pro-active identification; Training without pro-active identification

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.

Training with pro-active identification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. M.E. Numans

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 28, 2024
• Study Start: September 12, 2024
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: March 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)