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

N/ANot Yet RecruitingNCT07445529

Johns Hopkins University100 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Insomnia Stress Short Sleep Phenotype Race

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)".

Time frame: 5 weeks, 10 weeks, and 16 weeks

Secondary Outcomes

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).

Time frame: 5, 10, and 16 weeks

Central Contacts

Matthew Reid, Ph.D

CONTACT

6678951141 mreid27@jhmi.edu

Jim Stone, B.A.