Comparing CBT-I and Lemborexant for Chronic Insomnia
Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
This study is testing whether Cognitive Behavioral Therapy for Insomnia or the medication lemborexant can help people with insomnia, especially those dealing with anxiety and depression, feel better compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06779149 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) and the medication lemborexant compared to a placebo in treating insomnia disorder, particularly in individuals with anxiety and depressive symptoms. Participants will be randomly assigned to one of three groups: CBT-I, lemborexant, or placebo, over an 8-week treatment period. The study will also assess how different insomnia phenotypes, based on sleep duration, influence treatment outcomes. Assessments will occur at baseline, post-treatment, and at a 6-month follow-up to measure changes in sleep and mental health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the criteria for insomnia disorder and have mild symptoms of anxiety or depression.
Not a fit: Patients with severe psychiatric disorders, untreated major depression, or significant medical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for patients suffering from chronic insomnia and related mental health issues.
How similar studies have performed: Previous studies have shown promising results for both CBT-I and pharmacotherapy in treating insomnia, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec, Quebec
- Université Laval Centre d'étude des troubles du sommeil — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Charles M Morin, PhD — Université Laval Centre d'étude des troubles du sommeil
- Study coordinator: Manon Lamy
- Email: manon.lamy@psy.ulaval.ca
- Phone: 418-656-2131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.