Insomnia
Conditions
Keywords
Primary Care
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).
Interventions
OTHERTraining
A 4-hour training for PCPs consisting of an onsite training, an e-learning and a webinar on the treatment of insomnia.
OTHERPro-active identification
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.
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 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. |
| 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. |
| 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. |
| 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). |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORDennis O. Mook-Kanamori
Leiden University Medical Center (LUMC)
PRINCIPAL_INVESTIGATORRutger A. Middenburg
Leiden University Medical Center (LUMC)
PRINCIPAL_INVESTIGATORMattijs E. Numans
Leiden University Medical Center (LUMC)
Outcome results
None listed