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NOT YET RECRUITING
NCT07445529
NA

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-07-01

Completion Date

2030-01

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DEVICE

Cognitive Behavioral Therapy for Insomnia (CBTi)

Participants will be treated with a well validated digital Cognitive Behavioral Therapy for Insomnia (CBTi) program called Sleepio, over 6-10 weeks. The digital Cognitive Behavioral Therapy for Insomnia (dCBTi) is delivered on a mobile app or webpage that follows standard CBTi protocols. It is supported by evidence showing improvements in insomnia and depressive symptoms, as well as non-inferiority compared with face-to-face CBTi, amongst large (total\>10,000ppts), diverse populations. Sleepio is the first-line intervention for insomnia in the United Kingdom National Health Service.