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

NCT ID: NCT04350866

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 277920 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-07-31

Brief 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?

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.

Conditions

Chronic Insomnia

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: OTHER

Study Groups

Minneapolis VAMC

BBTI; ERIC strategies

Expert Recommendations for Implementing Change bundle of strategies

Intervention Type: 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

Brief Behavioral Treatment for Insomnia

Intervention Type: 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):

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.

Philadelphia VAMC

BBTI; ERIC strategies

Expert Recommendations for Implementing Change bundle of strategies

Intervention Type: 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

Brief Behavioral Treatment for Insomnia

Intervention Type: 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):

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.

Durham VAMC

BBTI; ERIC strategies

Expert Recommendations for Implementing Change bundle of strategies

Intervention Type: 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

Brief Behavioral Treatment for Insomnia

Intervention Type: 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):

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.

Baltimore VAMC

BBTI; ERIC strategies

Expert Recommendations for Implementing Change bundle of strategies

Intervention Type: 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

Brief Behavioral Treatment for Insomnia

Intervention Type: 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):

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ERIC; BBTI

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Not meeting above criteria

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Pittsburgh Healthcare System

FED

Sponsor Role: collaborator

VA Maryland Health Care System

FED

Sponsor Role: collaborator

Durham VA Health Care System

FED

Sponsor Role: collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

Corporal Michael J. Crescenz VA Medical Center

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam D. Bramoweth, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Locations

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39745672 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.youtube.com/watch?v=ZhFS5MLKrv0

Brief Behavioral Treatment for Insomnia (BBTI introduction for patients and providers)

https://www.youtube.com/watch?v=WmxphTTAg6U

The 2 Processes that Regulate Sleep and the 4 Rules to Improve Your Sleep

Other Identifiers

IIR 19-340

Identifier Type: -

Identifier Source: org_study_id