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The DigIT Trial: The Effectiveness and Implementation of a Coached Digital Insomnia Treatment Program in a Regional Healthcare System.

NCT05558475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-02-03

No results posted yet for this study

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. 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.

Conditions

  • Insomnia Disorder

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Eric Hermes, MD · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  • Christi S. Ulmer, PhD · Durham VA Medical Center, Durham, NC

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558475 on ClinicalTrials.gov