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Completed

NCT Number: NCT05182372

Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Columbus Medical Center

Novi, Michigan, 48377, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced dCBT-I

Behavioral

Telehealth Coaching

Primary outcomes

  1. Risk of treatment non-completion

    Time frame: throughout the study until the final study visit, up to 6 weeks

    Determined based on missing two consecutive sessions of dCBT-I.Missing two consecutive sessions equals being behind on sessions by 14 days.

  2. Treatment Completion

    Time frame: throughout the study until the final study visit, up to 6 weeks

    Completion of all 6 sessions of dCBT-I.

  3. Adherence to Sleep Restriction

    Time frame: throughout the study until the final study visit, up to 6 weeks

    Determined based on the variance of sleep diary variables

Secondary outcomes

  1. Insomnia

    Time frame: throughout the study until the final study visit, up to 6 weeks

    Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)

  2. Physical Environment

    Time frame: within 2 weeks of post-treatment

    Participants will be asked about the layout of their sleep environment as well as neighborhood characteristics. Sleep environment will be assessed using qualitative information on individual's surroundings and information such as their ability to adjust light levels, temperature, and sound. If it is easier for the individual to adjust these, then they have a better physical environment for sleep. Neighborhood characteristics will be evaluated with the Neighborhood Safety scale (scores range from 1 to 5; lower scores indicate more neighborhood safety).

  3. Sociocultural environment

    Time frame: within 2 weeks of post-treatment

    Sociocultural environment is measured using a household roster and the Everyday Discrimination Scale. A household roster will ask participants to report the number of individuals in the household and characterize the relationship with the participant. No summary score exists for the household roster. The Everyday Discrimination Scale measures frequency of discrimination (scores range from 10 to 60; higher scores represent more frequent experiences of discrimination).

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • National Jewish Health
  • University of Michigan

Registry information

Acronym: COACH

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2022
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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