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

Primary Purpose

Insomnia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced dCBT-I
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insomnia focused on measuring digital CBTI, Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Henry Ford Columbus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced dCBT-I

Control dCBT-I

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
Treatment Completion
Completion of all 6 sessions of dCBT-I.
Adherence to Sleep Restriction
Determined based on the variance of sleep diary variables

Secondary Outcome Measures

Insomnia
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
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).
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).

Full Information

First Posted
December 2, 2021
Last Updated
February 27, 2023
Sponsor
Henry Ford Health System
Collaborators
University of Michigan, National Jewish Health
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1. Study Identification

Unique Protocol Identification Number
NCT05182372
Brief Title
Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
Acronym
COACH
Official Title
Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
University of Michigan, National Jewish Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
digital CBTI, Insomnia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random assignment into experimental and control conditions at a 1:1 ratio
Masking
Investigator
Masking Description
The principle investigator will be blind to the group assignment
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced dCBT-I
Arm Type
Experimental
Arm 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.
Arm Title
Control dCBT-I
Arm Type
No Intervention
Arm Description
Participants in this group will complete dCBT-I individually without assistance from a healthcare provider
Intervention Type
Behavioral
Intervention Name(s)
Enhanced dCBT-I
Intervention Description
Telehealth Coaching
Primary Outcome Measure Information:
Title
Risk of treatment non-completion
Description
Determined based on missing two consecutive sessions of dCBT-I.Missing two consecutive sessions equals being behind on sessions by 14 days.
Time Frame
throughout the study until the final study visit, up to 6 weeks
Title
Treatment Completion
Description
Completion of all 6 sessions of dCBT-I.
Time Frame
throughout the study until the final study visit, up to 6 weeks
Title
Adherence to Sleep Restriction
Description
Determined based on the variance of sleep diary variables
Time Frame
throughout the study until the final study visit, up to 6 weeks
Secondary Outcome Measure Information:
Title
Insomnia
Description
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
Time Frame
throughout the study until the final study visit, up to 6 weeks
Title
Physical Environment
Description
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).
Time Frame
within 2 weeks of post-treatment
Title
Sociocultural environment
Description
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).
Time Frame
within 2 weeks of post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Cheng, PhD
Phone
(248)344-7361
Email
pcheng1@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alec Bayoneto, BS
Phone
2483444159
Email
abayone1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A Cheng, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Columbus Medical Center
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alec Bayoneto, B.S.
Phone
248-344-4159
Email
abayone1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Philip Cheng, PhD
Phone
2493447361
Email
pcheng1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Philip Cheng, PhD

12. IPD Sharing Statement

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Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities

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