The DigIT Trial: The Effectiveness and Implementation of a Coached Digital Insomnia Treatment Program in a Regional Healthcare System.
NCT ID: NCT05558475
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
244 participants
INTERVENTIONAL
2023-04-27
2025-12-31
Brief Summary
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Detailed Description
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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:
1. \[Establish effectiveness of Digital CBTi with Coaching when implemented in rural-facing VISN 1 facilities\] H1: Veterans randomized to Digital CBTi with Coaching will report greater improvement in insomnia severity (primary) and sleep parameters (secondary) compared to \[Digital CBTi+ Contact (an enhanced treatment as usual control)\]
2. 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.
3. 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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Digital CBTi with Coaching
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.
Virtual Coaching
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.
Digital CBTi without Coaching (+ initial contact)
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.
No interventions assigned to this group
Interventions
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Virtual Coaching
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.
Eligibility Criteria
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Inclusion Criteria
* have an interest in digital CBTi, and
* have basic technology literacy.
Exclusion Criteria
* Disorders: Psychotic DO; Bipolar DO;
* Dementia;
* moderate Cognitive Impairment;
* Epilepsy;
* Seizure DO,
* Severe OSA: untreated or treatment non-adherence,
* Current Exposure Therapy for PTSD
18 Years
100 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Eric Hermes, MD
Role: PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Christi S. Ulmer, PhD
Role: PRINCIPAL_INVESTIGATOR
Durham VA Medical Center, Durham, NC
Locations
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VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Maine VA Medical Center, Augusta, ME
Augusta, Maine, United States
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, United States
Manchester VA Medical Center, Manchester, NH
Manchester, New Hampshire, United States
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IIR 20-253
Identifier Type: -
Identifier Source: org_study_id
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