InsomniaNCT07445529
Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia
A study testing Cognitive Behavioral Therapy for Insomnia (CBTi) in people with Insomnia and Stress, run by Johns Hopkins University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Stress, Short Sleep Phenotype
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBTi)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBTi)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTi) | Other | Cognitive Behavioral Therapy for Insomnia (CBTi) intervention Receives: Device: Cognitive Behavioral Therapy for Insomnia (CBTi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)".
Measured: 5 weeks, 10 weeks, and 16 weeks
Secondary outcomes (1)
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).
Measured: 5, 10, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Sponsor
- Investigators
- Matthew Reid, Ph.D, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445529
- Sponsor's protocol ID
- IRB00467340
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The sharing of individual participant data (IPD) is not required by the current funder.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia
- ClinicalTrials.gov ID
- NCT07445529
- Acronym / sponsor ID
- IRB00467340
- Conditions
- Insomnia, Stress, Short Sleep Phenotype, Race
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTi) | Other | Device: Cognitive Behavioral Therapy for Insomnia (CBTi)Cognitive Behavioral Therapy for Insomnia (CBTi) intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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].
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Cognitive Behavioral Therapy for Insomnia (CBTi) |
Primary outcome
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)".
1 secondary outcome
Depressive Symptoms
Time frame: 5, 10, and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. The sharing of individual participant data (IPD) is not required by the current funder.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Reid, Ph.D principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBTi) in people with Insomnia and Stress, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Reid, Ph.D (6678951141, mreid27@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI Severity) (time frame: 5 weeks, 10 weeks, and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.