Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

Last updated: September 17, 2024
Sponsor: Henry Ford Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Treatment

Enhanced dCBT-I

Clinical Study ID

NCT05182372
14816
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Determination of insomnia (ISI >14)

Exclusion

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 Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Enhanced dCBT-I
Phase:
Study Start date:
May 18, 2022
Estimated Completion Date:
August 30, 2026

Study 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.

Connect with a study center

  • Henry Ford Columbus Medical Center

    Novi, Michigan 48377
    United States

    Active - Recruiting

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