Implementing Cognitive Behavioral Therapy for Insomnia (SWELL): Function QUERI 3.0

Part of paid clinical trials in Durham, North Carolina.

Sponsor
VA Office of Research and Development
Study ID
NCT07216261
Status
Recruiting
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Conditions

  • Chronic Insomnia

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Implementation Strategy: Foundational Arm — OTHER
    The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports, and education and training.
  • Implementation Strategy: REACH arm — OTHER
    The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.

Study Details

Implementing Cognitive Behavioral Therapy for Insomnia with Older Veterans (SWELL): Function QUERI 3.0 aims to compare implementation approaches while also gathering information on clinical effectiveness of the EBP in its new context. The overall goal is to implement, evaluate, and sustain SWELL in 20 VA facilities using a type III effectiveness-implementation hybrid study framework and parallel cluster randomized trial (CRT) design.

Key Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Foundational Arm
    Foundational Arm uses the Replicating Effective Program (REP) implementation strategy and includes 3 elements that were developed and tested in our prior Function QUERI work: program initiation, self-guided resources, and technical assistance.
  • Experimental: REACH (Reach Equity And Collective Health) Arm
    The REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring.

Primary Outcome Measure

Reach [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Heidi D Bassani
[email protected]
(919) 286-0411
Jaime Hughes, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
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