SWELL cognitive behavioral therapy program for chronic insomnia in older Veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.