InsomniaCOACHNCT05182372
Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
A study testing Enhanced dCBT-I in people with Insomnia, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Enhanced dCBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 6 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Determination of insomnia (ISI >14)
Who cannot join
- Age < 18
- Unwillingness/inability to participate
- Bipolar or Seizure Disorders
- Untreated sleep disorders other than insomnia
- Untreated and severe medical or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Columbus Medical Center
Novi, Michigan, 48377
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Enhanced dCBT-I
- Keywords
- digital CBTI, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced dCBT-IBehavioural
Telehealth Coaching
| Study group | Role | What they receive |
|---|---|---|
| Enhanced dCBT-I | Experimental | 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. Receives: Behavioral: Enhanced dCBT-I |
| Control dCBT-I | No intervention | Participants in this group will complete dCBT-I individually without assistance from a healthcare provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: throughout the study until the final study visit, up to 6 weeks
Treatment Completion
Completion of all 6 sessions of dCBT-I.
Measured: 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
Measured: throughout the study until the final study visit, up to 6 weeks
Secondary outcomes (3)
Insomnia
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
Measured: 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).
Measured: 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).
Measured: within 2 weeks of post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start18 May 2022
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment into experimental and control conditions at a 1:1 ratio
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Jewish Health
- Responsible party
- Principal investigator, Philip Cheng, Henry Ford Health System
- Investigators
- Philip A Cheng, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182372
- Sponsor's protocol ID
- 14816
- Acronym
- COACH
- Status last verified
- Oct 2025
- First submitted
- 2 Dec 2021
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Digital CBT-I to Improve Adherence and Reduce Disparities
- ClinicalTrials.gov ID
- NCT05182372
- Acronym / sponsor ID
- COACH / 14816
- Conditions
- Insomnia
- Keywords
- digital CBTI, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- University of Michigan, National Jewish Health
- Study start
- 18 May 2022 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Random assignment into experimental and control conditions at a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Enhanced dCBT-I | Experimental | Behavioral: Enhanced dCBT-IThis 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. |
| Control dCBT-I | No intervention | –Participants in this group will complete dCBT-I individually without assistance from a healthcare provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Determination of insomnia (ISI >14)
Key exclusion criteria (5 listed)
- Age < 18
- Unwillingness/inability to participate
- Bipolar or Seizure Disorders
- Untreated sleep disorders other than insomnia
- Untreated and severe medical or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced dCBT-ITelehealth Coaching | Behavioural | Enhanced dCBT-I |
Primary outcome
Risk of treatment non-completion
Time frame: throughout the study until the final study visit, up to 6 weeks
Determined based on missing two consecutive sessions of dCBT-I.Missing two consecutive sessions equals being behind on sessions by 14 days.
Treatment Completion
Time frame: throughout the study until the final study visit, up to 6 weeks
Completion of all 6 sessions of dCBT-I.
Adherence to Sleep Restriction
Time frame: throughout the study until the final study visit, up to 6 weeks
Determined based on the variance of sleep diary variables
3 secondary outcomes
Insomnia
Time frame: throughout the study until the final study visit, up to 6 weeks
Physical Environment
Time frame: within 2 weeks of post-treatment
Sociocultural environment
Time frame: within 2 weeks of post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip A Cheng, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced dCBT-I in people with Insomnia, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of treatment non-completion (time frame: throughout the study until the final study visit, up to 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.