Recruiting

Cognitive Behavioral Therapy

Sponsor:

VA Office of Research and Development

Code:

NCT07216261

Conditions

Chronic Insomnia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Implementation Strategy: Foundational Arm

Implementation Strategy: REACH arm

Study Details

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

Study ID

NCT07216261

Start date

Apr 30, 2026

Status verified date

May, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Implementation Strategy: REACH arm

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

Primary outcome measure

  • Reach [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Caitlin B Kappler, MSW

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

Locations

Durham VA Medical Center, Durham, NC

Recruiting

Durham, North Carolina, United States, 27705-3875

Contacts

Heidi D Bassani

(919) 286-0411Heidi.Bassani@va.gov

Principal Investigator:

Jaime Hughes, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-07.