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NCT Number: NCT07216261

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location status: Recruiting

Location contact

Heidi D Bassani

CONTACT

[email protected]

(919) 286-0411

Jaime Hughes, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reach

    Time frame: 18 months

    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.

Secondary outcomes

  1. Reach

    Time frame: 12 months

    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.

  2. Patient Engagement

    Time frame: 12 months

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

  3. Patient Engagement

    Time frame: 18 months

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

  4. Time to Adoption

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caitlin B Kappler, MSW

CONTACT

[email protected]

(919) 286-6936

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: SWELL

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 14, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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