Insomnia DisorderDigITNCT05558475
The DigIT Trial: The Effectiveness and Implementation of a Coached Digital Insomnia Treatment Program in a Regional Healthcare System.
A study testing Virtual Coaching in people with Insomnia Disorder, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
The study will evaluate the effectiveness and implementation of a Virtual Coaching Intervention to enhance use of a digital intervention delivering cognitive behavioral therapy for insomnia (digital CBTi) at primarily rural VISN 1 facilities. The digital CBTi program was developed by VA specifically for Veterans. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Virtual Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Apr 2023to 31 Dec 2025
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans who meet the ICSD-3 Insomnia disorder diagnostic criteria,
- have an interest in digital CBTi, and
- have basic technology literacy.
Who cannot join
- Nighttime or Rotating Shift Work within the last 6 Months,
- Disorders: Psychotic DO; Bipolar DO;
- Dementia;
- moderate Cognitive Impairment;
- Epilepsy;
- Seizure DO,
- Severe OSA: untreated or treatment non-adherence,
- Current Exposure Therapy for PTSD
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Maine VA Medical Center, Augusta, ME
Augusta, Maine, 04330
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
Manchester VA Medical Center, Manchester, NH
Manchester, New Hampshire, 03104-7007
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05001-3833
About this study
Official title: Path To Better Sleep + Virtual Coaching: The Effectiveness and Implementation of Internet-Based Self-Management Program for Insomnia in a Regional Healthcare System
The study will evaluate the effectiveness and implementation of a Virtual Coaching Intervention to enhance use of a digital intervention delivering cognitive behavioral therapy for insomnia (digital CBTi) at primarily rural VISN 1 facilities. The digital CBTi program was developed by VA specifically for Veterans. The Digital CBTi program contains the core elements of CBTi (sleep restriction, stimulus control, etc.) and matches the form of commercial digital CBTi programs, but is publicly available, currently in use in VA, and includes unique activities such as Veteran videos and various sleep diary options. A virtual coaching intervention, where a coach based in VA Connecticut will provide telephone coaching support to Veterans referred to Digital CBTi across VISN 1 sites, will increase engagement and adherence while fostering improved clinical outcomes. The investigators have hypothesized that Veterans randomized to Digital CBTi with Coaching will report greater improvement in insomnia severity and sleep parameters compared to Digital CBTi plus Contact (an enhanced treatment as usual control that provides an initial contact but NO coaching). The strategy used to implement Digital CBTi with Coaching will result in adequate Reach among Veterans (operationalized as 5 progressive levels of Veteran engagement in Digital CBTi) and Adoption among providers (2 progressive levels of provider engagement). A three-part formative evaluation of implementation (pre-implementation, active implementation, maintenance) consisting of interviews with Veterans, providers, and staff will optimize implementation in real time by tailoring implementation strategy elements to specific contexts.
Read the detailed description
Background:
As many as 1.8 million individuals using VA services meet criteria for insomnia disorder, a condition associated with suicide, poor functioning, and medical as well as mental health disorders. Cognitive Behavioral Therapy for insomnia (CBTi) is the gold-standard treatment. However, only a small fraction of Veterans receive CBTi due to a host of barriers, including lack of providers, travel, scheduling and stigma, which are particularly relevant to those using rural and low-resourced treatment settings. A digital intervention delivering CBTi has been developed by VA specifically for Veterans. PTBS, enhanced by personal coaching, may mitigate barriers to CBTi by enabling self-management beyond clinic walls.
Significance:
Current Digital CBTi dissemination practices consist of inadequate messaging, poor integration into clinical workflow, and the absence of personal support. Preliminary data indicate that while Digital CBTi has increased access to CBTi, only an estimated 0.8% of Veterans with insomnia disorder have visited the Digital CBTi site. To address these gaps, (1) coaching must be integrated with Digital CBTi (Digital CBTi with Coaching) to increase engagement/adherence and (2) Digital CBTi with Coaching must be embedded in current VA care practices using a scalable implementation strategy for digital interventions. Although other low impact or digital interventions for insomnia are in use by VA, the prevalence of insomnia far outweighs VA's capacity to deliver gold-standard treatment through any single modality. An array of treatment options is needed. Moreover, Digital CBTi coaching delivered through a hub-and-spoke model is a scalable approach to MISSION Act directives mandating evidence-based in rural areas.
Innovation and Impact:
The program is the first digital CBTi designed for Veterans. Digital CBTi is open access and meets stringent VA information security requirements. Coaching integrated into Digital CBTi will increase engagement and adherence. A hub-and-spoke model of coaching limits reliance on local facility resources. A scalable implementation strategy for digital interventions, optimized during an HSR\&D career development award, will be used. The VISN 1 clinical trials network will allow access to a rural Veteran population and provide research coordination resources.
Specific Aims:
- [Establish effectiveness of Digital CBTi with Coaching when implemented in rural-facing VISN 1 facilities] H1: Veterans randomized to Digital CBTi with Coaching will report greater improvement in insomnia severity (primary) and sleep parameters (secondary) compared to [Digital CBTi+ Contact (an enhanced treatment as usual control)]
- Evaluate the quantitative outcomes of REP-DI, the strategy used to embed Digital CBTi with Coaching in VA care. H2: REP-DI will result in adequate Reach among Veterans, Adoption among providers, and Maintenance.
- Conduct a 3-part (pre-implementation, active implementation, maintenance) formative evaluation of implementation. Interviews with Veterans, providers, and staff will be informed by constructs from the Consolidated Framework for Implementation Research (CFIR). Data will optimize implementation in real time by tailoring implementation strategy elements to specific contexts.
Methodology:
A pragmatic hybrid type-2 effectiveness/implementation mixed-methods trial will be used. Outpatients with insomnia disorder will be referred by VISN 1 providers and randomized to either Digital CBTi with Coaching or Digital CBTi with contact. The implementation strategy will be REP-DI, a scalable and resource efficient strategy for implementing digital interventions. REP-DI will include provider training and augmentation of site referral processes, among other activities, to support PTBS implementation. Outcomes will be evaluated according to the RE-AIM framework. Digital CBTi with Coaching effectiveness outcomes include insomnia severity (primary), sleep parameters, fatigue, mood, sedative-hypnotic use, and other measures collected at baseline, 8 weeks, and 6 months. REP-DI quantitative implementation outcomes will include progressive levels of Reach, Adoption, and Maintenance evaluated at patient and provider/staff levels. A 3-part formative evaluation of implementation and implementation strategy optimization process will identify patient and provider/staff determinants through qualitative analysis of semi-structured interviews.
Next Steps/Implementation:
Digital CBTi with Coaching can be implemented across VA using REP-DI by the National Center for Health Promotion and Disease Prevention and secondary VA partners such as the Offices of Rural Health and Connected Care.
- Conditions
- Insomnia Disorder
- Being tested
- Virtual Coaching
- Keywords
- Health Technology, Internet-based program, Self-management, Primary Care, Mental Health, Digital CBTi
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual CoachingBehavioural
The core coaching components are motivational support, clinical health education, and technical support. The specific objectives are: support PTBS engagement, foster subsequent treatment adherence, ensure appropriate implementation of guidelines for Sleep Restriction Therapy and Stimulus Control, identify and triage PTBS candidates who are not appropriate or need more intensive treatments, and provide PTBS course technical support.
| Study group | Role | What they receive |
|---|---|---|
| Digital CBTi with Coaching | Experimental | Virtual Coaching integrated with Digital CBTI. Includes initial enrollment contact, onboarding call, and two follow-up support calls. The coach will be available as resource for technical and other support. Receives: Behavioral: Virtual Coaching |
| Digital CBTi without Coaching (+ initial contact) | No intervention | The control will be an enhanced treatment as usual condition where participants will receive: 1) provider referral to Digital CBTi; 2) initial enrollment contact and 3) NO virtual coaching contacts. If subjects have a question or need technical support, they will be instructed to contact study staff for assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The ISI is the standard for self-reported insomnia symptoms. The ISI is a 7-item questionnaire (5-point Likert scale, total score ranges from 0-28) providing a global measure of perceived insomnia severity. The ISI has adequate psychometric properties and has been validated against sleep diary and polysomnographic measures of sleep.
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: change from baseline to 10 weeks
Insomnia Severity Index (ISI)
The ISI is the standard for self-reported insomnia symptoms. The ISI is a 7-item questionnaire (5-point Likert scale, total score ranges from 0-28) providing a global measure of perceived insomnia severity. The ISI has adequate psychometric properties and has been validated against sleep diary and polysomnographic measures of sleep.
Total score categories:
0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Measured: change from baseline to 6 months
Secondary outcomes (6)
Sleep Onset Latency (SOL)
Sleep onset latency (SOL) is the length of time that it takes to accomplish the transition from full wakefulness to sleep. It is measured in minutes where high number means longer time and low number means shorter time to fall asleep.
Measured: change from baseline to 10 weeks
Sleep Onset Latency (SOL)
Sleep onset latency (SOL) is the length of time that it takes to accomplish the transition from full wakefulness to sleep. It is measured in minutes where high number means longer time and low number means shorter time to fall asleep.
Measured: change from baseline to 6 months
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time to time in bed. It is given as a percentage where high percentage indicates normal/healthy SE (ex. 80-90%) while low percentage indicates low SE.
Measured: change from baseline to 10 weeks
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time to time in bed. It is given as a percentage where high percentage indicates normal/healthy SE (ex. 80-90%) while low percentage indicates low SE.
Measured: change from baseline to 6 months
Wake After Sleep Onset (WASO)
WASO (wake after sleep onset) is defined as an unwanted wake or waking period after sleep onset. By definition, sleep must continue after the wake in order for it to count as a WASO. WASO is measures in minutes where high number means longer time awake and low number means shorter time awake after sleep onset.
Measured: change from baseline to 10 weeks
Wake After Sleep Onset (WASO)
WASO (wake after sleep onset) is defined as an unwanted wake or waking period after sleep onset. By definition, sleep must continue after the wake in order for it to count as a WASO. WASO is measures in minutes where high number means longer time awake and low number means shorter time awake after sleep onset.
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start27 Apr 2023
- Primary completion31 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic mixed-models hybrid type-2 effectiveness-implementation trial will be used. 1) the effectiveness of a bundled clinical intervention: Digital CBTi plus Virtual Coaching Support (Digital CBTi with Coaching); and 2) a scalable implementation strategy for Digital CBTi with Coaching (REP-DI). The setting will be five healthcare systems within VISN 1: VA Maine, VA Central Western Massachusetts, VA White River Junction, VA Connecticut, and the Manchester VA. Interested and appropriate participants will undergo patient-level 1:1 stratified randomization to receive either Digital CBTi with Coaching or Digital CBTi+ Contact (control). All organizations will receive implementation activities and all participants will receive usual medical care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric Hermes, MD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CTChristi S. Ulmer, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558475
- Sponsor's protocol ID
- IIR 20-253
- Acronym
- DigIT
- Status last verified
- Jan 2026
- First submitted
- 22 Sep 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulmer CS, Jeffreys AS, Shannon J, Blythe A, Dennis PA, Chai W, Miles A, Rubin M, Rekart KN, Marteeny V, Breslin J, Solzhenitsyn C, Wendorf AR, Johnson A, Mattocks K, Martino S, Bosworth HB, Goodwin K, Gould C, Hiltner R, Knipping V, Marvin KA, Chen T, Hermes E. Coach supported digital cognitive behavioral therapy for insomnia: protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Sep 12:108470. doi: 10.1016/j.cct.2026.108470. Online ahead of print.
PubMed 42731804
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Path To Better Sleep + Virtual Coaching: The Effectiveness and Implementation of Internet-Based Self-Management Program for Insomnia in a Regional Healthcare System
- ClinicalTrials.gov ID
- NCT05558475
- Acronym / sponsor ID
- DigIT / IIR 20-253
- Conditions
- Insomnia Disorder
- Keywords
- Health Technology, Internet-based program, Self-management, Primary Care, Mental Health, Digital CBTi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Sep 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 study will evaluate the effectiveness and implementation of a Virtual Coaching Intervention to enhance use of a digital intervention delivering cognitive behavioral therapy for insomnia (digital CBTi) at primarily rural VISN 1 facilities. The digital CBTi program was developed by VA specifically for Veterans. The Digital CBTi program contains the core elements of CBTi (sleep restriction, stimulus control, etc.) and matches the form of commercial digital CBTi programs, but is publicly available, currently in use in VA, and includes unique activities such as Veteran videos and various sleep diary options. A virtual coaching intervention, where a coach based in VA Connecticut will provide telephone coaching support to Veterans referred to Digital CBTi across VISN 1 sites, will increase engagement and adherence while fostering improved clinical outcomes. The investigators have hypothesized that Veterans randomized to Digital CBTi with Coaching will report greater improvement in insomnia severity and sleep parameters compared to Digital CBTi plus Contact (an enhanced treatment as usual control that provides an initial contact but NO coaching). The strategy used to implement Digital CBTi with Coaching will result in adequate Reach among Veterans (operationalized as 5 progressive levels of Veteran engagement in Digital CBTi) and Adoption among providers (2 progressive levels of provider engagement). A three-part formative evaluation of implementation (pre-implementation, active implementation, maintenance) consisting of interviews with Veterans, providers, and staff will optimize implementation in real time by tailoring implementation strategy elements to specific contexts.
Detailed description
Background:
As many as 1.8 million individuals using VA services meet criteria for insomnia disorder, a condition associated with suicide, poor functioning, and medical as well as mental health disorders. Cognitive Behavioral Therapy for insomnia (CBTi) is the gold-standard treatment. However, only a small fraction of Veterans receive CBTi due to a host of barriers, including lack of providers, travel, scheduling and stigma, which are particularly relevant to those using rural and low-resourced treatment settings. A digital intervention delivering CBTi has been developed by VA specifically for Veterans. PTBS, enhanced by personal coaching, may mitigate barriers to CBTi by enabling self-management beyond clinic walls.
Significance:
Current Digital CBTi dissemination practices consist of inadequate messaging, poor integration into clinical workflow, and the absence of personal support. Preliminary data indicate that while Digital CBTi has increased access to CBTi, only an estimated 0.8% of Veterans with insomnia disorder have visited the Digital CBTi site. To address these gaps, (1) coaching must be integrated with Digital CBTi (Digital CBTi with Coaching) to increase engagement/adherence and (2) Digital CBTi with Coaching must be embedded in current VA care practices using a scalable implementation strategy for digital interventions. Although other low impact or digital interventions for insomnia are in use by VA, the prevalence of insomnia far outweighs VA's capacity to deliver gold-standard treatment through any single modality. An array of treatment options is needed. Moreover, Digital CBTi coaching delivered through a hub-and-spoke model is a scalable approach to MISSION Act directives mandating evidence-based in rural areas.
Innovation and Impact:
The program is the first digital CBTi designed for Veterans. Digital CBTi is open access and meets stringent VA information security requirements. Coaching integrated into Digital CBTi will increase engagement and adherence. A hub-and-spoke model of coaching limits reliance on local facility resources. A scalable implementation strategy for digital interventions, optimized during an HSR\&D career development award, will be used. The VISN 1 clinical trials network will allow access to a rural Veteran population and provide research coordination resources.
Specific Aims:
- [Establish effectiveness of Digital CBTi with Coaching when implemented in rural-facing VISN 1 facilities] H1: Veterans randomized to Digital CBTi with Coaching will report greater improvement in insomnia severity (primary) and sleep parameters (secondary) compared to [Digital CBTi+ Contact (an enhanced treatment as usual control)]
- Evaluate the quantitative outcomes of REP-DI, the strategy used to embed Digital CBTi with Coaching in VA care. H2: REP-DI will result in adequate Reach among Veterans, Adoption among providers, and Maintenance.
- Conduct a 3-part (pre-implementation, active implementation, maintenance) formative evaluation of implementation. Interviews with Veterans, providers, and staff will be informed by constructs from the Consolidated Framework for Implementation Research (CFIR). Data will optimize implementation in real time by tailoring implementation strategy elements to specific contexts.
Methodology:
A pragmatic hybrid type-2 effectiveness/implementation mixed-methods trial will be used. Outpatients with insomnia disorder will be referred by VISN 1 providers and randomized to either Digital CBTi with Coaching or Digital CBTi with contact. The implementation strategy will be REP-DI, a scalable and resource efficient strategy for implementing digital interventions. REP-DI will include provider training and augmentation of site referral processes, among other activities, to support PTBS implementation. Outcomes will be evaluated according to the RE-AIM framework. Digital CBTi with Coaching effectiveness outcomes include insomnia severity (primary), sleep parameters, fatigue, mood, sedative-hypnotic use, and other measures collected at baseline, 8 weeks, and 6 months. REP-DI quantitative implementation outcomes will include progressive levels of Reach, Adoption, and Maintenance evaluated at patient and provider/staff levels. A 3-part formative evaluation of implementation and implementation strategy optimization process will identify patient and provider/staff determinants through qualitative analysis of semi-structured interviews.
Next Steps/Implementation:
Digital CBTi with Coaching can be implemented across VA using REP-DI by the National Center for Health Promotion and Disease Prevention and secondary VA partners such as the Offices of Rural Health and Connected Care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic mixed-models hybrid type-2 effectiveness-implementation trial will be used. 1) the effectiveness of a bundled clinical intervention: Digital CBTi plus Virtual Coaching Support (Digital CBTi with Coaching); and 2) a scalable implementation strategy for Digital CBTi with Coaching (REP-DI). The setting will be five healthcare systems within VISN 1: VA Maine, VA Central Western Massachusetts, VA White River Junction, VA Connecticut, and the Manchester VA. Interested and appropriate participants will undergo patient-level 1:1 stratified randomization to receive either Digital CBTi with Coaching or Digital CBTi+ Contact (control). All organizations will receive implementation activities and all participants will receive usual medical care.
| Arm | Type | Receives |
|---|---|---|
| Digital CBTi with Coaching | Experimental | Behavioral: Virtual CoachingVirtual Coaching integrated with Digital CBTI. Includes initial enrollment contact, onboarding call, and two follow-up support calls. The coach will be available as resource for technical and other support. |
| Digital CBTi without Coaching (+ initial contact) | No intervention | –The control will be an enhanced treatment as usual condition where participants will receive: 1) provider referral to Digital CBTi; 2) initial enrollment contact and 3) NO virtual coaching contacts. If subjects have a question or need technical support, they will be instructed to contact study staff for assistance. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans who meet the ICSD-3 Insomnia disorder diagnostic criteria,
- have an interest in digital CBTi, and
- have basic technology literacy.
Key exclusion criteria (8 listed)
- Nighttime or Rotating Shift Work within the last 6 Months,
- Disorders: Psychotic DO; Bipolar DO;
- Dementia;
- moderate Cognitive Impairment;
- Epilepsy;
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 |
|---|---|---|
| Virtual CoachingThe core coaching components are motivational support, clinical health education, and technical support. The specific objectives are: support PTBS engagement, foster subsequent treatment adherence, ensure appropriate implementation of guidelines for Sleep Restriction Therapy and Stimulus Control, identify and triage PTBS candidates who are not appropriate or need more intensive treatments, and provide PTBS course technical support. | Behavioural | Digital CBTi with Coaching |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: change from baseline to 10 weeks
The ISI is the standard for self-reported insomnia symptoms. The ISI is a 7-item questionnaire (5-point Likert scale, total score ranges from 0-28) providing a global measure of perceived insomnia severity. The ISI has adequate psychometric properties and has been validated against sleep diary and polysomnographic measures of sleep. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Insomnia Severity Index (ISI)
Time frame: change from baseline to 6 months
The ISI is the standard for self-reported insomnia symptoms. The ISI is a 7-item questionnaire (5-point Likert scale, total score ranges from 0-28) providing a global measure of perceived insomnia severity. The ISI has adequate psychometric properties and has been validated against sleep diary and polysomnographic measures of sleep. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
6 secondary outcomes
Sleep Onset Latency (SOL)
Time frame: change from baseline to 10 weeks
Sleep Onset Latency (SOL)
Time frame: change from baseline to 6 months
Sleep Efficiency (SE)
Time frame: change from baseline to 10 weeks
Sleep Efficiency (SE)
Time frame: change from baseline to 6 months
Wake After Sleep Onset (WASO)
Time frame: change from baseline to 10 weeks
Wake After Sleep Onset (WASO)
Time frame: change from baseline to 6 months
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 3 Feb 2026.
- Derived from this study: PubMed 42731804Ulmer CS, Jeffreys AS, Shannon J, Blythe A, Dennis PA, Chai W, Miles A, Rubin M, Rekart KN, Marteeny V, Breslin J, Solzhenitsyn C, Wendorf AR, Johnson A, Mattocks K, Martino S, Bosworth HB, Goodwin K, Gould C, Hiltner R, Knipping V, Marvin KA, Chen T, Hermes E. Coach supported digital cognitive behavioral therapy for insomnia: protocol for a randomized controlled trial. Contemp Clin Trials. 2026 Sep 12:108470. doi: 10.1016/j.cct.2026.108470. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Eric Hermes, MD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Christi S. Ulmer, PhD principal investigator
Durham VA Medical Center, Durham, NC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Coaching in people with Insomnia Disorder, run by VA Office of Research and Development at 5 sites 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 3 inclusion and 8 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Insomnia Severity Index (ISI) (time frame: change from baseline to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558475, which also lists 1 linked publication.
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 3 Feb 2026.