SWELL cognitive behavioral therapy program for chronic insomnia in older Veterans
Implementing Cognitive Behavioral Therapy for Insomnia With Older Veterans: Function QUERI 3.0 (QUE 25-008)
This project will try two ways of rolling out SWELL, a five-session CBT for chronic insomnia, to help older Veterans get and benefit from treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07216261 on ClinicalTrials.gov |
What this trial studies
The project uses a type III effectiveness–implementation hybrid and a parallel cluster randomized design to implement the adapted CBTI program (SWELL) across 20 VA facilities. Two implementation strategies (a foundational arm and a REACH arm) are compared while collecting data on clinical outcomes and sustainment. SWELL is a five-week, provider-delivered program focused on sleep schedules, limiting non-sleep activities in bed, healthy sleep habits, relaxation, and changing unhelpful sleep expectations. The trial leverages a training and supervision model that has enabled non-psychologists to deliver CBTI in prior work.
Who should consider this trial
Good fit: Older Veterans (typically aged 60 and up) who meet criteria for chronic insomnia, are medically and psychiatrically stable enough for multi-session CBTI, and receive care at a participating VA primary care clinic are ideal candidates.
Not a fit: Patients younger than 60, those with contraindications (for example uncontrolled seizure disorder or bipolar I) or who are too medically or psychiatrically unstable for multi-session CBTI, and non-VA patients are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the project could increase access to an effective, age-friendly CBTI program for older Veterans and improve nighttime sleep and daytime functioning at scale.
How similar studies have performed: Prior trials of the adapted SWELL program showed significant improvements in nighttime sleep and daytime functioning lasting up to one year and demonstrated that non-psychologists can effectively deliver the therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jaime Hughes, PhD — Durham VA Medical Center, Durham, NC
- Study coordinator: Caitlin B Kappler, MSW
- Email: Caitlin.Kappler@va.gov
- Phone: (919) 286-6936
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.