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

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.

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.

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