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

Implementing Cognitive Behavioral Therapy for Insomnia With Older Veterans: Function QUERI 3.0 (QUE 25-008)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Other: Implementation Strategy: Foundational Arm; Other: Implementation Strategy: REACH arm

Detailed Description

Background/Purpose. As many as two-thirds of older Veterans meet criteria for chronic insomnia disorder, defined as three or more months of subjective complaints related to difficulty falling or staying asleep or waking too early and/or poor nighttime sleep associated with daytime impairment. Left untreated, chronic insomnia can negatively impact quality-of-life and contribute to accelerated cognitive and functional decline.

CBTI is the recommended first-line treatment for chronic insomnia; however, despite several VA initiatives focused on the scale-up of CBTI, fewer than 5% of older Veterans with chronic insomnia have received this evidence-based therapy. To address this challenge, the team adapted CBTI for older Veterans. In a series of trials to evaluate the adapted program, Sleep Well, Live Well (SWELL), the team found significant improvements in nighttime sleep and daytime functioning that lasted up to one year after the end of treatment. Notably, using a comprehensive training and supervision model, these studies demonstrated that non-psychologists can effectively deliver CBTI. The investigators' evidence-based and age-friendly CBTI program, SWELL, involves five sessions delivered weekly with a trained provider. Content focuses on establishing a regular sleep-wake schedule, moving non-sleep activities out of the bedroom, establishing healthy sleep habits, relaxation near bedtime, and addressing unhealthy expectations about sleep.

Objectives. The investigators plan to develop scalable approaches to implement and sustain SWELL as well as evaluate reach when delivered through the Foundational arm compared to an enhanced implementation strategy, the REACH (Reach Equity And Collective Health) arm.

Key questions. How can the REACH arm be optimized? What are shareholder perspectives on the refinement needs for SWELL foundational arm activities, as well as strategies to enhance equitable reach via the REACH arm? To address the question "Are there differences in implementation outcomes (reach [primary], patient engagement, time to adoption) between arms?", the investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 12 and 18 months (primary). Average time to adoption will be compared between study arms.

Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either the foundational arm or REACH arm. The investigators will use generalized linear models to examine the effect of foundational vs. REACH on implementation outcomes of reach and patient engagement at 18 months.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin B Kappler, MSW; Phone Number: (919) 286-6936; Email: Caitlin.Kappler@va.gov

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Recruiting
      • Durham VA Medical Center, Durham, NC
      • Contact: Heidi D Bassani; Phone Number: (919) 286-0411; Email: Heidi.Bassani@va.gov
      • Principal Investigator: Jaime Hughes, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Site Inclusion Criteria:

• 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.

Patient Inclusion Criteria:

• 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

Exclusion Criteria:

Site Exclusion Criteria:

• No members of the SWELL team working in the clinic

Patient Exclusion Criteria:

• younger than 60
• do not meet criteria for enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Implementation Strategy: REACH arm; The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.
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.	Other: Implementation Strategy: Foundational Arm; The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports, and education and training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Patient Engagement	Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.	12 months
Patient Engagement	Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.	18 months
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.	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of Treatment	Budget impacts will be assessed using implementation process data (e.g. office hours, Diffusion Network, and facilitation call notes) and VA salary and managerial cost accounting data to describe EBP delivery costs and to calculate the costs of the two implementation approaches (foundational REP and Reach+Equity). Two types of costs will be collected for each site using brief monthly surveys to track implementation activities: (1) clinical delivery team costs incurred; and (2) implementation strategy costs incurred. Unlike in a cost-effectiveness analysis evaluating two distinct treatments, the investigators will not evaluate healthcare costs because all individual participants will receive the same clinical treatment regardless of a site's implementation strategy.	18 months
Insomnia Severity	Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.	Baseline
Insomnia Severity	Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.	6 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jennifer L Martin, PhD, VA Greater Los Angeles Healthcare System, Sepulveda, CA; Principal Investigator: Jaime Hughes, PhD, Durham VA Medical Center, Durham, NC

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: October 8, 2025
• First Posted (Actual): October 14, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Veterans; Cognitive Behavioral Therapy; Sleep Disorders; Implementation Science; Functional Status
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
• Other Study ID Numbers: QUX 25-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored & maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that includes variables from statistical models presented in publication. 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.
• IPD Sharing Time Frame: Available upon request.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No