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

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:

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?

Study Overview

• Status: Completed
• Conditions: Chronic Insomnia
• Intervention / Treatment: Behavioral: Expert Recommendations for Implementing Change bundle of strategies; Behavioral: Brief Behavioral Treatment for Insomnia

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.

• Study Type: Observational
• Enrollment (Actual): 277920

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

Not meeting above criteria

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minneapolis VAMC; BBTI; ERIC strategies	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; Other Names: ERIC; 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): 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
Philadelphia VAMC; BBTI; ERIC strategies	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; Other Names: ERIC; 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): 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
Durham VAMC; BBTI; ERIC strategies	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; Other Names: ERIC; 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): 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
Baltimore VAMC; BBTI; ERIC strategies	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; Other Names: ERIC; 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): 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Veteran Participants Who Engaged in BBTI	The number of Veterans in PCMHI who engaged in BBTI as indicated in the medical records	54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
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.	54 months; All study phases (pre-training; pre-implementation; implementation; post-implementation)
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.	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.
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.	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.
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).	42 months; during the pre-implementation, implementation, and post-implementation phases.
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).	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)
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).	42 months; qualitative interviews took place at the end of the pre-implementation, implementation, and post-implementation phases.
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).	12 months: 4 times - every 3-months during the Implementation phase.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach-1 (change)	The number of new PCMHI visits related to insomnia, indicated by a PCMHI progress note in the medical records with an insomnia diagnostic code.	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Reach-2 (change)	The number of Veterans who initiate BBTI, indicated by a BBTI templated note in the medical records.	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Reach-3 (change)	The proportion of BBTI treatment starts (numerator) relative to the number of Veterans who are potentially eligible based on a PCMHI visit related to insomnia and/or Veterans seen in Primary Care since the start of a study phase (pre, implementation, post) with an insomnia diagnosis and/or a new or refilled sedative-hypnotic (denominator).	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Effectiveness (change)	Change on the Insomnia Severity Index (ISI) from the initial score obtained (e.g., PCMHI initial evaluation, BBTI session 1) to the last BBTI session. For Effectiveness to be calculated, ISI scores from each BBTI session (e.g., entered in a BBTI templated note) by PCMHI clinicians will be extracted through the automated Corporate Data Warehouse (CDW) queries to calculate outcomes for each Veteran. Rates of treatment response and remission will also be calculated. Response is a reduction of 8 points on the ISI from pre- to post-treatment. Remission is achieving a post-treatment response and an ISI <8.	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Adoption-1 (change)	The number of PCMHI clinicians who undergo training in BBTI relative to the number of PCMHI clinicians eligible for training.	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Adoption-2 (change)	The number of PCMHI clinicians who treat at least one Veteran with BBTI relative to the number of PCMHI clinicians trained.	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Implementation/treatment fidelity-1 (change)	Implementation will be measured by rating mock treatment sessions with trained PCMHI clinicians. Ratings will be completed by site PIs using the BBTI-Competency Rating Scale (BBTI-CRS). During the pre- and post-implementation phases, PCMHI clinicians will be rated quarterly but will not receive feedback. However, during the implementation phase, clinicians will receive feedback and any necessary re-training, from their site PI, if they score below the competency cutoff (<50% or <2 per item; 2=satisfactory).	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)
Implementation/treatment fidelity-2 (change)	As a secondary check of Implementation, PCMHI clinicians will have a random selection of BBTI progress notes reviewed, by their site PI, to assess BBTI elements being utilized (10% or at least 1 per month of eligible notes). Like the rated mock sessions, only during the implementation phase will PCMHI clinicians receive feedback regarding their progress notes.	change from pre-implementation phase (duration: 0, 6, 12, or 18 months [site dependent]) to implementation phase (duration: 12 months) to post-implementation phase (duration: 6 months)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Minneapolis Veterans Affairs Medical Center; VA Pittsburgh Healthcare System; Corporal Michael J. Crescenz VA Medical Center; Durham VA Health Care System; VA Maryland Health Care System
• Investigators: Principal Investigator: Adam D. Bramoweth, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Publications and helpful links

General Publications

• 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.

Helpful Links

• Brief Behavioral Treatment for Insomnia (BBTI introduction for patients and providers)
• The 2 Processes that Regulate Sleep and the 4 Rules to Improve Your Sleep

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; stepped-wedge design; hybrid implementation-effectiveness trial; primary care mental health integration
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IIR 19-340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No