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).

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Insomnia; Short Sleep Phenotype; Race
• Intervention / Treatment: Device: Cognitive Behavioral Therapy for Insomnia (CBTi)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Reid, Ph.D; Phone Number: 6678951141; Email: mreid27@jhmi.edu
• Study Contact Backup: Name: Jim Stone, B.A.; Phone Number: 4105507906; Email: jstone8@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Cognitive Behavioral Therapy for Insomnia (CBTi); Cognitive Behavioral Therapy for Insomnia (CBTi) intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	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).	5, 10, and 16 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: American Academy of Sleep Medicine
• Investigators: Principal Investigator: Matthew Reid, Ph.D, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
• Other Study ID Numbers: IRB00467340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sharing of individual participant data (IPD) is not required by the current funder.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No