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NCT05558475: DigIT
The DigIT Trial: The Effectiveness and Implementation of a Coached Digital Insomnia Treatment Program in a Regional Healthcare System.
NA trial testing Virtual Coaching in Insomnia Disorder in 244 participants. Completed in 31 December 2025.
31 October 2025
Quick facts
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 244 |
| Start date | 27 April 2023 |
| Primary completion | 31 October 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Virtual Coaching
Conditions studied
- Insomnia Disorder — all drugs for Insomnia Disorder →
Sponsor
VA Office of Research and Development — full company profile →
Who can join
Adults 18 to 100, any sex, with Insomnia Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05558475
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Insomnia Disorder
Currently open trials in the same condition.
- NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
- NCT06626048 — Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study · NA · active not recruiting
- NCT06669507 — The Sleep Clinic Outcome and Practice Study · NA · recruiting
- NCT06335784 — Mental Imagery and Targeted Memory Reactivation in Insomnia · NA · recruiting
- NCT05924425 — Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease · Phase 4 · recruiting
Other VA Office of Research and Development trials
Trials by the same sponsor.
- NCT07456150 — Personalizing Veteran Pain Care: Adapting Coaching Interventions to Support Maintenance of Self-Care · Phase 1 · not yet recruiting
- NCT06746727 — The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veteran · NA · not yet recruiting
- NCT07362576 — Perinatal Peer Support for Veterans With Serious Mental Illness · NA · not yet recruiting
- NCT06766331 — Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans · NA · not yet recruiting
- NCT07397195 — ACT for Veterans With IBD and Mental Health Challenges · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05558475 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
- Last refreshed: 3 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05558475.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing