Insomnia in Primary Care

Leiden University Medical Center (LUMC)

Status: Enrolling

Conditions: Insomnia

Treatments: Other: Training; Other: Pro-active identification

Study type: Interventional

Funder types: Other

Identifiers

NCT06575998

80-83910-98-1158 (Other Grant/Funding Number)

N24.054

Details and patient eligibility

About

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).

Enrollment: 315 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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315 participants in 3 patient groups

Training with pro-active identification

Experimental group

Description:

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

Treatment:

Other: Pro-active identification

Other: Training

Training without pro-active identification

Experimental group

Description:

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

Treatment:

Other: Training

Control

No Intervention group

Description:

Care as usual according to national applicable primary guide guidelines.