AzTrials
AzTrials

Chronic InsomniaNCT04350866

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

An observational study of Chronic Insomnia, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Insomnia
What is being tested?
Expert Recommendations for Implementing Change bundle of strategies and Brief Behavioral Treatment for Insomnia
How many people
277,920 participants
Where
1 siteUnited States
Study dates
1 Feb 2021to 31 Jul 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Four (4) VAMCs will be randomized to the order in which they will receive the intervention (stepped wedge). At each VAMC, retrospective data will be collected on Veterans who receive care in Primary Care and Primary Care Mental Health Integration (PCMHI). Our goal is to identify Veterans who engage in Brief Behavioral Treatment for Insomnia (BBTI) in a PCMHI clinic. Our goal is to collect data on at least 332 Veterans during the implementation phase (n=83 Veterans/site).

Who may be able to join

  • All Veterans in Primary Care and Primary Care Mental Health Integration (PCMHI) at the participating sites.

Who cannot join

  • Not meeting above criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

Other trials in United States

About this study

Official title: Enhancing Access to Insomnia (EASI) Care: Implementing Brief Behavioral Treatment for Insomnia in Primary Care Mental Health Integration 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 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:

Read more

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?

Read the detailed description

Chronic insomnia, one of the most common health problems among Veterans, significantly impacts health, function, and quality of life. Cognitive Behavioral Therapy for Insomnia (CBTI) is the first line treatment; however, despite efforts to train VA clinicians to deliver CBTI, there are still significant barriers to providing adequate access to insomnia care. Up to 44% of Veterans seen in Primary Care report insomnia, making it an optimal clinical setting for improving access to insomnia care. Furthermore, Brief Behavioral Treatment for Insomnia (BBTI), adapted from CBTI as a briefer, more flexible treatment, is easily delivered by Primary Care Mental Health Integration (PCMHI) clinicians and can greatly improve access to care for Veterans with insomnia. Yet, simply training PCMHI clinicians to deliver BBTI is not enough. Implementation strategies are needed for successful uptake, adoption, and sustainable delivery of care.

This stepped-wedge, hybrid III implementation-effectiveness trial involves four VA Medical Centers: Baltimore, Durham, Minneapolis, and Philadelphia. The hybrid design allows for testing of implementation and treatment effectiveness. The stepped-wedge design allows for fewer sites to achieve adequate power as all sites are exposed to BBTI training (BBTI) and BBTI + Implementation Strategies (BBTI+IS). The target sample are PCMHI clinicians and the impact of a bundle of strategies on the success of sustainable delivery of BBTI in Primary Care. Retrospective data collected from VA electronic health records will be used to obtain variables of interest related to Veteran treatment outcomes and data related to PCMHI clinician delivery of BBTI.

We will compare the impact PCMHI clinicians trained to deliver BBTI vs. the impact of BBTI training plus 12-months of access to an implementation strategy bundle (BBTI+IS). BBTI+IS vs. BBTI training alone is expected to result in more Veterans with access to insomnia care in PCMHI. We will also compare delivery of BBTI across all four phases, from pre-training to post-implementation. We will also measure Veteran-level outcomes for insomnia severity and PCMHI clinician fidelity on delivery of BBTI.

Outcome measures have been updated to reflect study protocol and analyses more accurately. Some of the prespecified Primary and Secondary Outcome Measures have been combined with one removed due to no data collection. The results reported reflect data that has been collected and analyzed.

Being tested
Expert Recommendations for Implementing Change bundle of strategies, Brief Behavioral Treatment for Insomnia
Keywords
Veterans, stepped-wedge design, hybrid implementation-effectiveness trial, primary care mental health integration
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expert Recommendations for Implementing Change bundle of strategiesBehavioural

    Also called ERIC

    • 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

  • Brief Behavioral Treatment for InsomniaBehavioural

    Also called BBTI

    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.

Study groups in NCT04350866
Study groupRoleWhat they receive
Minneapolis VAMCBBTI; ERIC strategies
Receives: Behavioral: Expert Recommendations for Implementing Change bundle of strategies; Behavioral: Brief Behavioral Treatment for Insomnia
Philadelphia VAMCBBTI; ERIC strategies
Receives: Behavioral: Expert Recommendations for Implementing Change bundle of strategies; Behavioral: Brief Behavioral Treatment for Insomnia
Durham VAMCBBTI; ERIC strategies
Receives: Behavioral: Expert Recommendations for Implementing Change bundle of strategies; Behavioral: Brief Behavioral Treatment for Insomnia
Baltimore VAMCBBTI; ERIC strategies
Receives: Behavioral: Expert Recommendations for Implementing Change bundle of strategies; Behavioral: Brief Behavioral Treatment for Insomnia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Veteran Participants Who Engaged in BBTI

    The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records

    Measured: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)

Secondary outcomes (8)

  1. Veterans in PCMHI Identified With Insomnia

    The number of Veterans with encounters in PCMHI related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.

    Measured: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)

  2. Veterans in Primary Care Identified With Insomnia

    The number of Veterans with encounters in Primary Care related to insomnia, indicated by an insomnia diagnostic code and/or insomnia-related medication.

    Measured: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)

  3. BBTI Effectiveness (Intent to Treat)

    Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.

    Measured: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 1-13 weeks.

  4. BBTI Effectiveness (Per Protocol)

    Change on the Insomnia Severity Index (ISI; 0-28, low scores indicate lower severity) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the final score documented in medical records. Data aggregated across phases (averaged) for first session and last session.

    Measured: 42 months; during the pre-implementation, implementation, and post-implementation phases. Time from BBTI first session to BBTI last session varies, but can range 2-13 weeks.

  5. PCMHI Providers (Staff) Who Delivered (Adopted) BBTI

    PCMHI providers (Staff) who delivered (adopted) BBTI (adopted) to at least 1 Veteran - measured in each phase (pre-implementation, implementation, post-implementation).

    Measured: 42 months; during the pre-implementation, implementation, and post-implementation phases.

  6. Implementation/Treatment Fidelity (Staff)

    Mean Competency Rating Score (0-36, higher scores indicate higher competency, >17 indicates competency)

    PCMHI providers (Staff) were measured via mock treatment sessions by site PIs/subject matter experts using the BBTI-Competency Rating Scale (BBTI-CRS) during the pre-implementation, implementation, and post-implementation phases. Overall refers to aggregate ratings (averaged) from all phases in which BBTI-CRS was delivered - providers could complete up to 5 ratings (up to 3 for pre-implementation, 1 for implementation, and 1 for post-implementation).

    Measured: 42 months; the BBTI-CRS was administered during pre-implementation (up to 3 times), implementation (1 time, at the end), and post-implementation (1 time, at the end)

  7. Barriers & Facilitators (CFIR Determinants)

    Strength and valence rating for identified barriers and facilitators (determinants) from the Consolidated Framework for Implementation Research (CFIR) qualitative interviews. CFIR determinants, identified through qualitative interviews with PCMHI providers, were rated on strength (0, 1, 2; higher numbers indicate stronger influence) and valence (- indicates negative/harmful influence; + indicates positive/helpful influence) to determine how helpful or harmful an identified CFIR determinant is for implementing BBTI in PCMHI. Ratings were aggregated across sites and phases (consensus by 3 raters with adjudication by PI as needed).

    Measured: 42 months; qualitative interviews took place at the end of the pre-implementation, implementation, and post-implementation phases.

  8. Implementation Strategy Utilization Survey

    Indication of implementation strategy utilization (yes/no) and rating of its importance (1 = not at all important, 5 = very important) and feasibility ((1 = not at all feasible, 5 = very feasible).

    Measured: 12 months: 4 times - every 3-months during the Implementation phase.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2020
  2. Study start1 Feb 2021
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Other
Enrolment
277,920 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04350866
Sponsor's protocol ID
IIR 19-340
Status last verified
Jan 2026
First submitted
31 Mar 2020
Last updated
12 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bramoweth AD, Ulmer CS, Klingaman EA, O'Brien EM, Deininger CJ, Boudreaux-Kelly MY, Youk AO. Delivery of Behavioral Insomnia Care in VA Primary Care Mental Health Integration Clinics: Sustainment Outcomes of a Hybrid Type 3 Trial. J Gen Intern Med. 2026 Oct 23. doi: 10.1007/s11606-026-10950-1. Online ahead of print.

    PubMed 42920076

  • Bramoweth AD, Hough CE, O'Brien EM, Klingaman EA, Deininger CJ, Ulmer CS, Boudreaux-Kelly MY, McCoy JL, Youk AO. Implementing brief behavioral treatment for insomnia in Department of Veterans Affairs Primary Care Mental Health Integration clinics: Reach outcomes from a hybrid type 3 effectiveness-implementation trial. Psychol Serv. 2025 Aug;22(3):409-422. doi: 10.1037/ser0000924. Epub 2025 Jan 2.

    PubMed 39745672

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Insomnia, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Veteran Participants Who Engaged in BBTI (time frame: 54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04350866, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in