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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Facility is part of the U.S. Department of Veterans Affairs (VA) health system.

Primary care clinic providing care to older Veterans

Clinic is located 25 miles from the nearest other VA clinic participating in the program

Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.

Disqualifiers

No members of the SWELL team working in the clinic

younger than 60

do not meet criteria for enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implementation Strategy: Foundational Arm

    Other intervention

    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 intervention

    The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Foundational ArmActive comparator 1 intervention
Group B: REACH (Reach Equity And Collective Health) ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reach

Reach will be defined as the number of older Veterans who initiate SWELL at a site. Initiation is defined as completing the first SWELL treatment session.

Time frame
18 months

Secondary outcomes

1

Reach

Reach will be defined as the number of older Veterans who initiate SWELL at a site. Initiation is defined as completing the first SWELL treatment session.

Time frame
12 months
2

Patient Engagement

Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.

Time frame
12 months
3

Patient Engagement

Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.

Time frame
18 months
4

Time to Adoption

Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (Adoption is defined at 5 or more enrolled Veterans who have initiated SWELL). This will be computed for each site meeting the adoption criteria.

Time frame
18 months

Other outcomes

Sponsors and contacts

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