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Enhancing Access to Insomnia (EASI) Care in VA PCMHI Clinics

NCT04350866 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 277920

Last updated 2026-01-12

Study results available
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Summary

This multi-site project (four VA Medical Centers) will test two approaches to improving the delivery of a behavioral insomnia treatment in the Primary Care setting to Veterans. The first approach is training providers to deliver Brief Behavioral Treatment for Insomnia (BBTI). The second approach is to give providers trained in BBTI additional support and resources to enhance their ability to deliver BBTI, what we call implementation. This project will measure delivery of BBTI over four phases: (1) pre-training; (2) pre-implementation; (3) implementation; and (4) post-implementation.

The main questions to answer:

Does delivery of BBTI improve with training alone and does it improve further with the addition of implementation support?

Does delivery of BBTI remain at similar levels after implementation support is removed?

Do Veterans who engage in BBTI reduce their insomnia symptoms?

Conditions

  • Chronic Insomnia

Interventions

BEHAVIORAL

Expert Recommendations for Implementing Change bundle of strategies

* Develop a formal implementation blueprint/checklist * Conduct educational meetings * Develop and distribute educational materials * Organize implementation meetings * Facilitation * Increase demand with marketing to patients * Promote adaptability

BEHAVIORAL

Brief Behavioral Treatment for Insomnia

An adapted version of Cognitive Behavioral Therapy for Insomnia (CBT-I) that is focused on behavioral components stimulus control and sleep restriction (the four rules): 1. Reduce time awake in bed. 2. Don't go to bed unless ready for sleep. 3. Don't stay in bed unless asleep. 4. Get up and out of bed at the same time everyday. Delivered weekly to bi-weekly over 4-6 sessions, with each session typically 30 minutes or less, consistent with other interventions delivered in PCMHI.

Sponsors & Collaborators

  • VA Pittsburgh Healthcare System

    collaborator FED

  • VA Maryland Health Care System

    collaborator FED

  • Durham VA Health Care System

    collaborator FED

  • Minneapolis Veterans Affairs Medical Center

    collaborator FED

  • Corporal Michael J. Crescenz VA Medical Center

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Adam D. Bramoweth, PhD · VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT04350866 on ClinicalTrials.gov