An interventional study of Virtual Coaching in Insomnia Disorder, sponsored by VA Office of Research and Development. Completed at 5 sites in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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:
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 592 are open to participants now.
This study's enrollment of 244 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Virtual Coaching
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.
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.
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)
Time frame: 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)
Time frame: change from baseline to 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: change from baseline to 6 months
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