Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
NCT ID: NCT05182372
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2022-05-18
2026-08-30
Brief Summary
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Detailed Description
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This study will examine the addition of telehealth coaching to dCBT-I to increase adherence rates. Telehealth coaching will aim to provide support to mitigate the impact of lower health literacy, and will also enhance self-efficacy as a mechanism to promote treatment persistence.
Participants will be recruited from the Henry Ford Health System (HFHS) outpatient network as well as the Medicare/Medicaid data warehouse. Subjects will be screened to determine eligibility, and then will be randomized into one of two insomnia treatment groups (control dCBT-I and dCBT-I with telehealth coaching). Treatment involves 6 weekly dCBT-I sessions. In the dCBT-I with coaching component, those who are at risk for treatment non-completion will be offered two telehealth sessions of brief behavioral therapy for insomnia. Those in the control dCBT-I who are at risk for treatment non-completion will be provided digital sleep education.
At the end of the treatment period, some participants will complete a semi-structured interview to assess for facilitators and barriers to treatment engagement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Enhanced dCBT-I
This 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.
Enhanced dCBT-I
Telehealth Coaching
Control dCBT-I
Participants in this group will complete dCBT-I individually without assistance from a healthcare provider
No interventions assigned to this group
Interventions
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Enhanced dCBT-I
Telehealth Coaching
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unwillingness/inability to participate
* Bipolar or Seizure Disorders
* Untreated sleep disorders other than insomnia
* Untreated and severe medical or psychiatric disorders
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
National Jewish Health
OTHER
Henry Ford Health System
OTHER
Responsible Party
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Philip Cheng
Principal Investigator
Principal Investigators
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Philip A Cheng, PhD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Columbus Medical Center
Novi, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14816
Identifier Type: -
Identifier Source: org_study_id
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