Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
COACH
1 other identifier
interventional
600
1 country
1
Brief Summary
The primary objective of this research study is to increase adherence of Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). Additionally, this study will examine behavioral, physical, and sociocultural factors associated with treatment engagement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2021
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedStudy Start
First participant enrolled
May 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2026
ExpectedApril 13, 2026
October 1, 2025
4 years
December 2, 2021
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Risk of treatment non-completion
Determined based on missing two consecutive sessions of dCBT-I.Missing two consecutive sessions equals being behind on sessions by 14 days.
throughout the study until the final study visit, up to 6 weeks
Treatment Completion
Completion of all 6 sessions of dCBT-I.
throughout the study until the final study visit, up to 6 weeks
Adherence to Sleep Restriction
Determined based on the variance of sleep diary variables
throughout the study until the final study visit, up to 6 weeks
Secondary Outcomes (3)
Insomnia
throughout the study until the final study visit, up to 6 weeks
Physical Environment
within 2 weeks of post-treatment
Sociocultural environment
within 2 weeks of post-treatment
Study Arms (2)
Enhanced dCBT-I
EXPERIMENTALThis group will complete d-CBTI and be assigned a coach that will help with completion of the treatment and will be available to call personally to discuss questions and issues.
Control dCBT-I
NO INTERVENTIONParticipants in this group will complete dCBT-I individually without assistance from a healthcare provider
Interventions
Eligibility Criteria
You may qualify if:
- Determination of insomnia (ISI \>14)
You may not qualify if:
- Age \< 18
- Unwillingness/inability to participate
- Bipolar or Seizure Disorders
- Untreated sleep disorders other than insomnia
- Untreated and severe medical or psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ford Health Systemlead
- University of Michigancollaborator
- National Jewish Healthcollaborator
Study Sites (1)
Henry Ford Columbus Medical Center
Novi, Michigan, 48377, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip A Cheng, PhD
Henry Ford Health System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The principle investigator will be blind to the group assignment
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 2, 2021
First Posted
January 10, 2022
Study Start
May 18, 2022
Primary Completion
April 30, 2026
Study Completion (Estimated)
August 30, 2026
Last Updated
April 13, 2026
Record last verified: 2025-10