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

NCT07216261 | Not Yet 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 address a key priority within the implementation science field - identifying and refining metrics for equity and impact. 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 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 (primary) will be defined as the number of older Veterans who initiate SWELL at six, 12, and 18 (primary) months.

  18 months

Secondary Outcomes (2)

• Fidelity

  18 months

• Adoption

  18 months

Other Outcomes (3)

• Cost of Treatment

  18 months

• Insomnia Severity

  Baseline

• Insomnia Severity

  6 weeks

Study Arms (2)

Foundational Support

ACTIVE COMPARATOR

Foundational Support uses the Replicating Effective Program (REP) implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: shareholder engagement, SWELL toolkit, online shared resources (SharePoint) access for clinical program training materials, data reports to assist sites with tracking their data, and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Other: Implementation Strategy: Foundational Support

Reach+Equity Bundle

EXPERIMENTAL

The Reach+Equity bundle will include the same activities as foundational support plus the Reach+Equity bundle activities which include: 1) external facilitation (designed to provide an outside perspective to help sites identify barriers, develop effective strategies, and navigate complex change processes particularly through the lens of achieving equitable reach); 2) equity in implementation toolkit (guide that supports awareness and consideration of equitable program reach and delivery during the implementation process); and 3) equity-focused data-driven monitoring (inform progress regarding equitable reach-related goals).

Other: Implementation Strategy: Reach+Equity Bundle

Interventions

Implementation Strategy: Foundational Support OTHER

The primary goal of SWELL is to compare implementation approaches while also gathering information on clinical effectiveness of the EBP in its new context. All sites will be randomized to receive 1) foundational REP implementation support alone or 2) foundational REP and Reach+Equity. We propose that low intensity implementation support that promotes engagement with SWELL (defined as foundational support), will be sufficient for some but not all facilities to successfully incorporate SWELL into routine practice.

Also known as: Foundational REP

Foundational Support

Implementation Strategy: Reach+Equity Bundle OTHER

We hypothesize that adding the Reach+Equity bundle to foundational REP, compared to foundational REP alone, will result in superior implementation outcomes.

Also known as: Enhanced Support

Reach+Equity Bundle

Eligibility Criteria

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

You may qualify if:

• meet diagnostic criteria for chronic insomnia disorder (with or without documented diagnosis)
• absence of a CBTI contraindication
• i.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
• patients can be referred to SWELL by a clinician or self-referred

You may not qualify if:

• 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

Location

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 (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 14, 2025

Record last verified: 2025-10

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)