Skip to main content
OpenTrials
Completed

NCT Number: NCT04350866

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 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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Not meeting above criteria

Treatment and study plan

Expert Recommendations for Implementing Change bundle of strategies

Behavioral
  • 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

Other names: ERIC

Brief Behavioral Treatment for Insomnia

Behavioral

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):

  • Reduce time awake in bed.
  • Don't go to bed unless ready for sleep.
  • Don't stay in bed unless asleep.
  • 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.

Other names: BBTI

Primary outcomes

  1. Veteran Participants Who Engaged in BBTI

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

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

Secondary outcomes

  1. Veterans in PCMHI Identified With Insomnia

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

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

  2. Veterans in Primary Care Identified With Insomnia

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

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

  3. BBTI Effectiveness (Intent to Treat)

    Time frame: 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.

    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.

  4. BBTI Effectiveness (Per Protocol)

    Time frame: 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.

    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.

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

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

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

  6. Implementation/Treatment Fidelity (Staff)

    Time frame: 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)

    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).

  7. Barriers & Facilitators (CFIR Determinants)

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

    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).

  8. Implementation Strategy Utilization Survey

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

    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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Corporal Michael J. Crescenz VA Medical Center
  • Durham VA Health Care System
  • Minneapolis Veterans Affairs Medical Center
  • VA Maryland Health Care System
  • VA Pittsburgh Healthcare System

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2020
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.