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

Henry Ford Health

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: Enhanced dCBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT05182372

14816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Enhanced dCBT-I

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced dCBT-I

Control dCBT-I

No Intervention group

Description:

Participants in this group will complete dCBT-I individually without assistance from a healthcare provider