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

February 27, 2023 updated by: Philip Cheng, Henry Ford Health System
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Novi, Michigan, United States, 48377
        • Recruiting
        • Henry Ford Columbus Medical Center
        • Contact:
        • Principal Investigator:
          • Philip Cheng, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Enhanced dCBT-I
Telehealth Coaching
No Intervention: Control dCBT-I
Participants in this group will complete dCBT-I individually without assistance from a healthcare provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
throughout the study until the final study visit, up to 6 weeks
Treatment Completion
Time Frame: throughout the study until the final study visit, up to 6 weeks
Completion of all 6 sessions of dCBT-I.
throughout the study until the final study visit, up to 6 weeks
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
throughout the study until the final study visit, up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
throughout the study until the final study visit, up to 6 weeks
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).
within 2 weeks of post-treatment
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).
within 2 weeks of post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

University of Michigan
National Jewish Health

Investigators

  • Principal Investigator: Philip A Cheng, PhD, Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2022

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

August 30, 2026

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14816

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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