Insomnia, Race, Short Sleep Phenotype, Stress
Conditions
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).
Interventions
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.
Sponsors
Johns Hopkins University
American Academy of Sleep Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI Severity) | 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
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 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). |
Contacts
CONTACTMatthew Reid, Ph.D
CONTACTJim Stone, B.A.
PRINCIPAL_INVESTIGATORMatthew Reid, Ph.D
Johns Hopkins University
Outcome results
None listed