Not Yet RecruitingNot Applicable

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

100 participantsStarted 2026-07-01

Plain-language 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).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Insomnia Severity Index (ISI Severity)

Timeframe: 5 weeks, 10 weeks, and 16 weeks

Trial details

NCT IDNCT07445529

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-01

Contact for this trial

Matthew Reid, Ph.D

6678951141 mreid27@jhmi.edu

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