NCT04350866

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277,920

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

March 31, 2020

Results QC Date

June 26, 2025

Last Update Submit

January 9, 2026

Conditions

Chronic Insomnia

Keywords

Veteransstepped-wedge designhybrid implementation-effectiveness trialprimary care mental health integration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Veterans in PCMHI Identified With Insomnia

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

  • Veterans in Primary Care Identified With Insomnia

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

  • BBTI Effectiveness (Intent to Treat)

    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)

    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

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

  • +3 more secondary outcomes

Study Arms (4)

Minneapolis VAMC

BBTI; ERIC strategies

Behavioral: Expert Recommendations for Implementing Change bundle of strategiesBehavioral: Brief Behavioral Treatment for Insomnia

Philadelphia VAMC

BBTI; ERIC strategies

Behavioral: Expert Recommendations for Implementing Change bundle of strategiesBehavioral: Brief Behavioral Treatment for Insomnia

Durham VAMC

BBTI; ERIC strategies

Behavioral: Expert Recommendations for Implementing Change bundle of strategiesBehavioral: Brief Behavioral Treatment for Insomnia

Baltimore VAMC

BBTI; ERIC strategies

Behavioral: Expert Recommendations for Implementing Change bundle of strategiesBehavioral: Brief Behavioral Treatment for Insomnia

Interventions

Brief Behavioral Treatment for InsomniaBEHAVIORAL

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.

Also known as: BBTI
Baltimore VAMCDurham VAMCMinneapolis VAMCPhiladelphia VAMC
Expert Recommendations for Implementing Change bundle of strategiesBEHAVIORAL

* 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

Also known as: ERIC
Baltimore VAMCDurham VAMCMinneapolis VAMCPhiladelphia VAMC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • Not meeting above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • 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.

    PMID: 39745672DERIVED

Related Links

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Adam Bramoweth, PhD
Organization
VA Pittsburgh Healthcare System
adam.bramoweth@va.gov
412-360-2806

Study Officials

  • Adam D. Bramoweth, PhD

    VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 17, 2020

Study Start

February 1, 2021

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

January 12, 2026

Results First Posted

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)