Clinical trial NCT05182372: Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
Official title: Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: digital CBTI
Insomnia
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Jewish Health
First posted: 2022-01-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment into experimental and control conditions at a 1:1 ratio
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Risk of treatment non-completion
timeFrame: throughout the study until the final study visit, up to 6 weeks
measure: Treatment Completion
timeFrame: throughout the study until the final study visit, up to 6 weeks
measure: Adherence to Sleep Restriction
timeFrame: throughout the study until the final study visit, up to 6 weeks
Secondary outcomes:
measure: Insomnia
timeFrame: throughout the study until the final study visit, up to 6 weeks
measure: Physical Environment
timeFrame: within 2 weeks of post-treatment
measure: Sociocultural environment
timeFrame: within 2 weeks of post-treatment
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Columbus Medical Center
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Philip A Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: