Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
ConditionInsomnia Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLaval University
About this trial
The primary aims of this study is to contrast the effectiveness of CBT-I and pharmacotherapy (lemborexant) compared to placebo on sleep and mental health outcomes in people with insomnia disorder and anxiety/depressive symptoms. In addition, the study will evaluate whether insomnia phenotypes (i.e., +/- 6hrs of sleep) at baseline moderate the effectiveness of the intervention on both sleep and mental health outcomes.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Cognitive Behavioral Treatment for Insomnia (CBT-I)
- Lemborexant
- Placebo
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Laval University
Lead sponsor
Toronto Metropolitan University
Collaborator
The Royal Ottawa Mental Health Centre
Collaborator
Source ClinicalTrials.gov