Insomnia in Primary Care

Not Applicable

Recruiting

• Conditions: Insomnia
• Interventions: Other: Training; Other: Pro-active identification

• Registration Number: NCT06575998
• Lead Sponsor: Leiden University Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-16
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Study Start: 2024-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Primary Completion: 2026-09-09
• Study Completion: 2026-09-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 315

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training with pro-active identification	Training	For detailed description of the intervention, see the separate section on interventions.
Training without pro-active identification	Training	For detailed description of the intervention, see the separate section on interventions.
Training with pro-active identification	Pro-active identification	For detailed description of the intervention, see the separate section on interventions.

Primary Outcome Measures

Name	Time	Method
Change in patient reported insomnia symptoms using the Insomnia Severity Index (ISI)	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 Outcome Measures

Name	Time	Method
Change in patient reported depression symptoms	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.
Report by the PCP of a non-pharmacological 'sleep consultation'	12 months after baseline questionnaire	PCP reported sleep consultation (survey answer yes/no) combined with PCP reported sleep medication use (survey answer yes/no).
Change in patient reported anxiety symptoms	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.
Patient reported non-pharmacological 'sleep consultation'	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).
Change in report of sleep medication use	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).
Change in patient reported general health status	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.

Trial Locations

Locations (1)

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Zuid-Holland, Netherlands