Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Insomnia (CBTi).
- Who it may be relevant to
- Registry conditions: Insomnia, Stress, Short Sleep Phenotype, Race. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 i
Primary outcome measures
- Insomnia Severity Index (ISI Severity) [Time frame: 5 weeks, 10 weeks, and 16 weeks]
Secondary outcome measures (1)
- Depressive Symptoms [Time frame: 5, 10, and 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07445529 · IRB00467340