Insomnia in Primary Care

Leiden University Medical Center315 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

315

Conditions

Insomnia

Interventions

TrainingOTHER

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

Pro-active identificationOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Leiden University Medical Center (LUMC)

Leiden, South Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Maria C.N. Meijer

CONTACT

0031 71 526 9111 m.c.n.meijer@lumc.nl

Data from ClinicalTrials.gov

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