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

Completed · Not applicable

Conditions studied: Insomnia Disorder

In brief

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.

Key facts

Study ID

NCT05558475

Run by

VA Office of Research and Development

People needed

244

Starts

2023-04-27

Expected to finish

2025-12-31

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Veterans who meet the ICSD-3 Insomnia disorder diagnostic criteria,
• have an interest in digital CBTi, and
• have basic technology literacy.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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