ArticleBMC psychiatry2025
Efficacy of cognitive behavioral therapy for insomnia and lemborexant medication for different subtypes of chronic insomnia: study protocol for a randomized controlled trial.
Article in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06779149 (Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of CBT-I and Lemborexant Medication for Different Subtypes of Chronic Insomnia
Who cites it
1 citing paper in PubMed.
- From night-to-night and from person-to-person: dynamic phenomena of insomnia.Sleep advances : a journal of the Sleep Research Society · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
introductionInsomnia is a prevalent yet under-characterized disorder, particularly regarding the heterogeneity of patients and their associated responses to different treatment modalities. This often leads to suboptimal management. There is a need to consider personalized approaches tailored to the characteristics of insomnia phenotypes with regard to objective evidence of shortened sleep duration (< 6 h). This study will examine whether there is a differential treatment response to cognitive behavioral therapy for insomnia (CBT-I) versus pharmacotherapy (lemborexant) as a function of insomnia phenotypes (i.e., ± 6 h of sleep).
methodsThis study is a three-arm pragmatic randomized clinical trial, which will enroll 90 adults with chronic insomnia disorder and anxiety/depressive symptoms. Eligible participants will be randomized to one of three conditions (1:1:1) involving CBT-I, lemborexant (Dual Orexin Receptor Antagonist) or placebo medication. Treatment outcomes will be assessed at post-treatment and 6-month follow-up. Insomnia symptom severity as measured by the Insomnia Severity Index will serve as the primary outcome for treatment comparisons. Secondary outcomes will include daily sleep/wake variables derived from the Consensus Sleep Diary, subjective measures of fatigue, mood, mental well-being, functional impairments, and sleep-related beliefs and attitudes. In addition, changes in cognitive performance will be examined as an exploratory outcome. Sleep reactivity and arousal level will be evaluated as potential mediators of treatment-related changes in CBT-I and pharmacotherapy. DISCUSSION: This study will contribute to the development of personalized medicine for managing different insomnia phenotypes and will have implication for knowledge mobilization of sleep research.
trial registrationClinicalTrials.gov. Identifier: NCT06779149. Registered on 12 January 2025.
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