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

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with long-lasting insomnia who also have at least mild anxiety or depression symptoms. It compares CBT-I (talk therapy for sleep), lemborexant and placebo.

Életkor

18 years or older

Nem

All sexes

A betegség stádiuma

Insomnia disorder by DSM-5 criteria, with an Insomnia Severity Index (ISI) score > 10 and a score ≥ 2 on the interference or distress item. Also mild anxiety or depression symptoms: PHQ-9 > 4 and/or GAD-7 > 4.

Korábbi kezelés

People cannot join if they use sleep medicines or cannabis products for sleep more than two nights per week. They also cannot join if they now use tricyclic antidepressants, MAO inhibitors or atypical antidepressants.

A részvétel fő kizáró okai

• Ever diagnosed with a psychotic or bipolar disorder, an untreated mental illness, or a risk of suicide
• Alcohol or drug use disorder in the past year, or 2 or more alcoholic drinks per day on 3 days or more per week
• Life-threatening or worsening illness, lung or breathing problems, or another sleep disorder such as sleep apnea
• Night shifts more than five nights per month in the last six months, or very late sleep schedules
• Pregnant or breastfeeding, or not using any birth control

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 3 csoportja

• Cognitive Behavioral Treatment for Insomnia (CBT-I)A vizsgált kezelés

  Participants in this treatment group will receive CBT-I. CBT-I sessions will occur weekly for the first 4 sessions and biweekly for the last 2 sessions (treatment phase is thus 8 weeks). : Graduate level students in clinical psychology will serve as therapists for this project.

• Lemborexant medicationA vizsgált kezelés

  Participants assigned to this group will be prescribed 5 to 10 mg of lemborexant to be taken at bedtime in 5 mg capsules. Lemborexant (Dayvigo) is a Dual Orexin Receptor Antagonist approved by Health Canada for the treatment of adult with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.

  Kezelés: Lemborexant

• PlaceboPlacebo, összehasonlításként

  Participants assigned to this group will be prescribed 5 to 10 mg of placebo to be taken at bedtime in 5 mg capsules identical to lemborexant. Pharmacy staff will package medications for each participant in a generic bottle labeled with the participant's ID code and treatment dates (identical for the lemborexant and placebo arms). Six consultation visits will be conducted during the 8-week treatment phase to monitor treatment response and drug side effects. The starting dose will be 5 mg with titration to 10 mg if needed (i.e., based on clinical response and tolerability) following the first week.