Treatment of Insomnia in Primary Care Study

Study Overview
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Brief Summary
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The goal of this clinical trial is to learn about insomnia treatment among primary care patients with chronic insomnia. The main question it aims to answer is: • Does Sleep School (a therapy for insomnia) work well to decrease harm of insomnia? Participants will attend a group therapy intervention once a week for six weeks. Researchers will compare Sleep School to treatment as usual (short counselling by an educated nurse) to see if the Sleep School works better than treatment as usual in decreasing the harm of insomnia.

Official Title
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Treatment of Insomnia in Primary Care Study

Conditions
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Insomnia Chronic

Intervention / Treatment
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* Behavioral: Sleep School
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia severity index (ISI) score at least 8 insomnia symptoms present at least for 3 months Exclusion Criteria: diagnosed dementia based on medical records acute suicidality acute psychotic symptoms

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep School<br>Participants attend the Sleep School once a week for six weeks. | Behavioral: Sleep School<br>* Sleep school is a structured method for the treatment of insomnia, which is based on cognitive behavioral therapy for insomnia (CBT-I). The central element of the method is a workbook for the patients. The essential parts of the method are strengthening the patient's self-efficacy, introducing the therapeutic exercises, and supporting the continued use of the exercises. The main themes of the Sleep school are information about sleep and the factors affecting it, behavioural components of CBT-I, like restricting the time spent in bed, cognitive components of CBT-I, like constructive worrying -exercise, and the exercises that aim to calm down mind and the autonomic nervous system. The Sleep School is held by an educated nurse.<br>|
| Active Comparator: Treatment as usual<br>Participants receive short counselling about insomnia at the enrollment visit. | Behavioral: Treatment as usual<br>* Oral and written information about improving sleep habits given by an educated nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in Insomnia Severity Index (ISI) score at 8 weeks | The ISI is a validated self-report tool for assessing the severity, and impact of current insomnia symptoms. It consists of 7 Likert-scale questions with a total score ranging from 0 to 28 (with higher scores indicating more severe insomnia). Change = Week 8 score - Baseline score. | Baseline and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in Patient Health Questionnaire 9 (PHQ-9) at 8 weeks | PHQ-9 is a validated self-administered instrument assessing each of the 9 Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria for depression as 0 (not at all) to 3 (nearly every day), and the severity of depression. Possible scores range from 0 to 27. Change = Week 8 score - Baseline score. | Baseline and Week 8 | 
| Mean change from Baseline in EUROHIS Quality of Life 8-item Index at 8 weeks | EUROHIS Quality of Life 8-item Index is a validated instrument for the assessment of general quality of life. There are altogether eight questions about the general, physical, psychological, social, and environmental aspects of quality of life. Every question is scored from 1 (very poor) to 5 (very good). All scores can be added together and divided by 8 (the sum of the questions) to obtain the EUROHIS-QOL mean score. Change = Week 8 score - Baseline score. | Baseline and Week 8 | 
| Mean change from Baseline in Work Ability Score (WAS) at 8 weeks | The WAS is the first item of the Work Ability Index (WAI), a validated instrument for the assessment of work ability. WAS is a single question What is your current work ability compared to your lifetime best? It has a 0-10 response scale, where 0 stands for completely unable to work and 10 stands for work ability at its best. The WAS has been shown to have a strong association with the WAI and is reliable in evaluating work ability. Change = Week 8 score - Baseline score. | Baseline and Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioral therapy for insomnia, CBT-I, Primary care, Insomnia severity index, Quality of life, Depressive symptoms