Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia

Launched by LAVAL UNIVERSITY · Jan 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring how well two treatments—Cognitive Behavioral Therapy for Insomnia (CBT-I) and a medication called lemborexant—work for people with chronic insomnia and symptoms of anxiety or depression. The study aims to see if these treatments help improve sleep and mental health compared to a placebo (a treatment that has no active ingredients). Additionally, researchers want to find out if different types of insomnia, based on how many hours of sleep people usually get, affect how well these treatments work.

To participate, individuals must be at least 18 years old and diagnosed with insomnia, experiencing some level of anxiety or depression. They should also be able to read and understand English or French and use a smartphone or computer with internet access. Participants will be closely monitored and will receive either the CBT-I, the medication, or a placebo. It's important to note that people with certain mental health conditions, specific sleep disorders, or serious medical illnesses may not be eligible for this trial. If you or someone you know is struggling with insomnia and meets the criteria, this study might offer a new way to find relief.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older at the time of enrolment
• • Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for insomnia disorder (Duke Sleep Interview), with total Insomnia Severity Index (ISI) score \> 10, and score ≥ 2 on either the interference or distress item
• • Minimal symptoms of anxiety and/or depression with Patient Health Questionnaire (PHQ-9) \> 4 and/or Generalized Anxiety Disorder (GAD-7) \> 4
• • Ability to read and understand French or English
• • Ability to use a smartphone, tablet, or computer, and access to home internet connection
• Exclusion Criteria:
• • Presence of a lifetime diagnosis of any psychotic or bipolar disorder
• • Untreated psychiatric disorder (e.g., major depression) or risk for suicide
• • Substance/alcohol use disorder within the past year
• • Any life-threatening or progressive medical illness (e.g., cancer, chronic obstructive pulmonary disease) or neurological degenerative disease (e.g., dementia)
• • Current use of sleep-promoting medications (prescribed or over-the-counter) or cannabis-derived products for sleep more than two nights per week
• • Current use of tricyclic antidepressants, monoamine oxidase inhibitors, or atypical antidepressants
• • Reported diagnosis of sleep disorder other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, rapid eye movement behavior disorder, delayed phase sleep disorder, narcolepsy)
• • Total score \> 5 on the Stop-Bang Questionnaire and/or clinical symptoms suggestive of sleep apnea (excessive daytime sleepiness), or Epworth score \> 10, restless legs syndrome or other signs of other sleep disorders
• • Atypical sleep schedules (i.e., habitual bedtimes later than 2:00 AM and rising times later than 10:00 AM on more than two days/nights per week as documented from a sleep diary)
• • Working night shifts more than five nights per month in the last six months
• • Consuming 2 or more alcoholic beverages per day regularly (3 days or more per week)
• • Any contra-indications to using the study medication, including lung disease/breathing problems (e.g., chronic obstructive pulmonary disease), use of strong or moderate CYP3A inducers (strong - rifampin, carbamazepine, and St. John's Wort) (moderate - bosentan, efavirenz, etravirine, and modafinil), pregnant and breastfeeding women
• • Not using any method of birth control