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

NCT05558475 | Completed

• 1 other identifier: IIR 20-253
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Health Technology; Internet-based program; Self-management; Primary Care; Mental Health; Digital CBTi

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  change from baseline to 6 months

Secondary Outcomes (6)

• Sleep Onset Latency (SOL)

  change from baseline to 10 weeks

• Sleep Onset Latency (SOL)

  change from baseline to 6 months

• Sleep Efficiency (SE)

  change from baseline to 10 weeks

• Sleep Efficiency (SE)

  change from baseline to 6 months

• Wake After Sleep Onset (WASO)

  change from baseline to 10 weeks

Study Arms (2)

Digital CBTi with Coaching

EXPERIMENTAL

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

Digital CBTi without Coaching (+ initial contact)

NO INTERVENTION

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.

Interventions

Virtual Coaching BEHAVIORAL

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 with Coaching

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (5)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

Maine VA Medical Center, Augusta, ME

Augusta, Maine, 04330, United States

Location

VA Central Western Massachusetts Healthcare System, Leeds, MA

Leeds, Massachusetts, 01053-9764, United States

Location

Manchester VA Medical Center, Manchester, NH

Manchester, New Hampshire, 03104-7007, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05001-3833, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Eric Hermes, MD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

• Christi S. Ulmer, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: A pragmatic mixed-models hybrid type-2 effectiveness-implementation trial will be used. 1) the effectiveness of a bundled clinical intervention: Digital CBTi plus Virtual Coaching Support (Digital CBTi with Coaching); and 2) a scalable implementation strategy for Digital CBTi with Coaching (REP-DI). The setting will be five healthcare systems within VISN 1: VA Maine, VA Central Western Massachusetts, VA White River Junction, VA Connecticut, and the Manchester VA. Interested and appropriate participants will undergo patient-level 1:1 stratified randomization to receive either Digital CBTi with Coaching or Digital CBTi+ Contact (control). All organizations will receive implementation activities and all participants will receive usual medical care.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 28, 2022
• Study Start: April 27, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)