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

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).

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Race Short Sleep Phenotype Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBTi)

Device

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.

Primary outcomes

Insomnia Severity Index (ISI Severity)

Time frame: 5 weeks, 10 weeks, and 16 weeks

The Insomnia Severity Index (ISI) defines insomnia severity by how high the score is. Participants rate each item on the questionnaire using Likert-type scales. Each of the responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. A total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "subthreshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe)".

Secondary outcomes

Depressive Symptoms

Time frame: 5, 10, and 16 weeks

Depressive symptoms defined by the Patient Health Questionnaire (PHQ-9). Score range 0 to 27, with higher scores indicating greater severity. Scores are categorized as 0-4 (None-Minimal), 5-9 (Mild), 10-14 (Moderate), 15-19 (Moderately Severe), and 20-27 (Severe).

Study contacts

Contact information is provided by the study sponsor or research team.

Jim Stone, B.A.

CONTACT

[email protected]

4105507906

Matthew Reid, Ph.D

CONTACT

[email protected]

6678951141

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

American Academy of Sleep Medicine

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2030
First posted: Mar 3, 2026
Registry last updated: Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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