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

NCT07216261 | Recruiting

• 1 other identifier: QUX 25-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Insomnia

Keywords

Sleep Disorders; Implementation Science; Functional Status; Quality of Life; Cognitive Behavioral Therapy; Veterans

Outcome Measures

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.

  18 months

Secondary Outcomes (4)

• Reach

  12 months

• Patient Engagement

  12 months

• Patient Engagement

  18 months

• Time to Adoption

  18 months

Study Arms (2)

Foundational Arm

ACTIVE COMPARATOR

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.

Other: Implementation Strategy: Foundational Arm

REACH (Reach Equity And Collective Health) Arm

EXPERIMENTAL

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.

Other: Implementation Strategy: REACH arm

Interventions

Implementation Strategy: REACH arm OTHER

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

REACH (Reach Equity And Collective Health) Arm

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.

Foundational Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• meet diagnostic criteria for chronic insomnia disorder (with or without documented diagnosis)
• absence of a CBTI contraindication oi.e., comorbid condition that makes CBTI unsafe), including uncontrolled seizure disorders, bipolar disorder I, and/or too medically or psychiatrically unstable to engage in a multi-session treatment opatients can be referred to SWELL by a clinician or self-referred

You may not qualify if:

• No members of the SWELL team working in the clinic
• younger than 60
• do not meet criteria for enrollment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaime Hughes, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

• Jennifer L Martin, PhD

  VA Greater Los Angeles Healthcare System, Sepulveda, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin B Kappler, MSW

CONTACT

(919) 286-6936; Caitlin.Kappler@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to one of two interventions: Foundational support only (active comparator) vs. Foundational support plus Reach+Equity Implementation Bundle (experimental).

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 14, 2025
• Study Start: April 30, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available upon request.
• Access Criteria: Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.

Locations

US (1)