Clinical Trial

Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia

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Summary
The purpose of this study is to understand whether Black participants with insomnia with objective short-sleep (ISSD) experience less symptom improvement in response to Cognitive Behavioral Therapy for Insomnia (CBTi) than Insomnia with Normal Sleep Duration (INSD) and whether this difference is driven by downstream racism-related stress and experiences. The investigators propose an innovative pragmatic open-label design in which Black participants with insomnia undergo a standard 6-week protocol of digital CBTi. The investigators will quantify ISSD using wireless EEG and will gather high-resolution naturalistic data of racism-related stress using random smartphone prompts and Ecological Momentary Assessments (EMA).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-25.
Trial Details
NCT Number NCT07445529
Lead Sponsor Johns Hopkins University
Collaborators: American Academy of Sleep Medicine
Conditions Insomnia, Stress, Short Sleep Phenotype, Race
Enrollment 100 participants
Start Date 2026-09-01
Primary Completion 2029-01-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-22