Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Enhanced dCBT-I


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Random assignment into experimental and control conditions at a 1:1 ratio
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital CBTI, Insomnia