Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

Insomnia Clinical Trial

— COACH  

Official title:

Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05182372
• Other study ID #: 14816
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: August 30, 2026

Study information

• Verified date: February 2023
• Source: Henry Ford Health System
• Contact: Philip Cheng, PhD
• Phone: (248)344-7361
• Email: pcheng1[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 30, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Enhanced dCBT-I
Telehealth Coaching

Locations

Country	Name	City	State
United States	Henry Ford Columbus Medical Center	Novi	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Henry Ford Health System	National Jewish Health, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of treatment non-completion	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
Primary	Treatment Completion	Completion of all 6 sessions of dCBT-I.	throughout the study until the final study visit, up to 6 weeks
Primary	Adherence to Sleep Restriction	Determined based on the variance of sleep diary variables	throughout the study until the final study visit, up to 6 weeks
Secondary	Insomnia	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
Secondary	Physical Environment	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
Secondary	Sociocultural environment	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