Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities (COACH)

  • STATUS
    Recruiting
  • End date
    Aug 30, 2026
  • participants needed
    600
  • sponsor
    Henry Ford Health System
Updated on 4 October 2022
behavior therapy

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.

Description

Insomnia is a debilitating condition that impacts one third of adults, with a majority not having access to proper treatment. Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). is a method that is becoming more accessible and with strong success rate with treatment completion; however, non-completion rates are common, specifically in those with low socioeconomic status (SES).

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.

Details
Condition Insomnia
Treatment Enhanced dCBT-I
Clinical Study IdentifierNCT05182372
SponsorHenry Ford Health System
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Determination of insomnia (ISI >14)

Exclusion Criteria

Age < 18
Unwillingness/inability to participate
Bipolar or Seizure Disorders
Untreated sleep disorders other than insomnia
Untreated and severe medical or psychiatric disorders
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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