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NCT07445529
Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia
Conditions: Insomnia, Stress, Short Sleep Phenotype, Race
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Johns Hopkins University
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).
Eligibility Criteria
Inclusion Criteria:
* Non-Hispanic Black adults
* aged 18-65 years with
* Clinically Significant \[Insomnia Severity Index (ISI) score \> 1048\] insomnia symptoms and
* clinically significant depressive symptoms \[PHQ-9 total score \>9\].
Exclusion Criteria:
* Current alcohol or substance use issues,
* Current active suicidal ideation
* Current shift-worker or frequent time zone travel
* Severe psychiatric morbidity within 6 months or lifetime history of bipolar disorder, mania, psychotic disorder
* delirium or dementia, which would interfere with participation
* major medical comorbidities
* history of seizures
* sleep apnea
* Lastly, people using antidepressant or psychiatric medications may be included if on a stable dosage for the last 1-month prior to the study and intend to remain on the medication during the study.
Source: ClinicalTrials.gov (NCT07445529). StuddyBuddy aggregates publicly available trial information.