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

NCT07445529 | Not Yet Recruiting

• 1 other identifier: IRB00467340
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Insomnia; Stress; Short Sleep Phenotype; Race

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI Severity)

  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)".

  5 weeks, 10 weeks, and 16 weeks

Secondary Outcomes (1)

• Depressive Symptoms

  5, 10, and 16 weeks

Study Arms (1)

Cognitive Behavioral Therapy for Insomnia (CBTi)

OTHER

Cognitive Behavioral Therapy for Insomnia (CBTi) intervention

Device: Cognitive Behavioral Therapy for Insomnia (CBTi)

Interventions

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.

Cognitive Behavioral Therapy for Insomnia (CBTi)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Hispanic Black adults
• aged 18-65 years with
• Clinically Significant \[Insomnia Severity Index (ISI) score \> 1048\] insomnia symptoms and
• clinically significant depressive symptoms \[PHQ-9 total score \>9\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Academy of Sleep Medicine: collaborator

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Reid, Ph.D

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Reid, Ph.D

CONTACT

6678951141; mreid27@jhmi.edu

Jim Stone, B.A.

CONTACT

4105507906; jstone8@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share