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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University

About this trial

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).

Eligibility criteria

Qualifiers

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].

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cognitive Behavioral Therapy for Insomnia (CBTi)

Treatment groups

100 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Johns Hopkins University

Lead sponsor

American Academy of Sleep Medicine

Collaborator