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Enhancing Access to Insomnia (EASI) Care in VA PCMHI Clinics
NCT04350866 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BEHAVIORAL Brief Behavioral Treatment for Insomnia
- BEHAVIORAL Expert Recommendations for Implementing Change bundle of strategies
Study Locations (1)
Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277,920 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2024-07-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04350866
The ClinicalTrials.gov registry entry for NCT04350866 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 277,920 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Insomnia appearing as the primary indexed condition, and to 2 interventions — of which Brief Behavioral Treatment for Insomnia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04350866 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04350866 about?
NCT04350866 is a clinical study titled "Enhancing Access to Insomnia (EASI) Care in VA PCMHI Clinics". 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 ...
What is the current status of trial NCT04350866?
This trial is currently completed. The enrollment target is 277,920 participants. The study started on 2021-02-01. Estimated completion is 2024-07-31.
What conditions does trial NCT04350866 study?
This clinical trial studies the following conditions: Chronic Insomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04350866?
The interventions under investigation include: Brief Behavioral Treatment for Insomnia (BEHAVIORAL), Expert Recommendations for Implementing Change bundle of strategies (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04350866?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04350866 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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