Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT07216261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2025-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing Cognitive Behavioral Therapy for Insomnia (SWELL): Function QUERI 3.0
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Implementing Cognitive Behavioral Therapy for Insomnia With Older Veterans: Function QUERI 3.0 (QUE 25-008)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWELL
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 address a key priority within the implementation science field - identifying and refining metrics for equity and impact. 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 CRT design.
Detailed Description:
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 with foundational support versus the enhanced implementation strategy (Reach+Equity bundle).
Key questions. How can the Reach+Equity bundle be optimized? What are shareholder perspectives on the refinements needs for SWELL foundational activities, as well as strategies to enhance equitable reach (Reach+Equity bundle)? Are there differences in implementation outcomes (reach, fidelity, adoption, cost) at six, 12, and 18 months between arms? Is reach representative of Veterans experiencing chronic insomnia at participating sites (equitable reach) and does this differ between arms? Are there differences in effectiveness outcomes (insomnia severity, function) between arms? How do sites experience implementation strategies in each arm? To address the question: Are there differences in implementation outcomes (reach \[primary\], fidelity, adoption) between arms? The investigators will use generalized linear models to examine the effect of foundational REP vs. Reach+Equity on implementation outcomes of reach and fidelity at 6, 12, and 18-months (primary). The investigators will examine how implementation outcomes change over time using descriptive methods (e.g. plots, descriptive statistics, subgroups). The investigators will compare average time to adoption between study arms. The investigators will examine equitable reach by calculating participation to prevalence ratios (PPRs) by site and implementation arm. The investigators will explore ratios by rurality and gender as well as race, sex and age. To address the question: Are there differences in effectiveness outcomes (insomnia symptoms, function) between arms, the investigators will describe effectiveness outcomes for patients who initiate the SWELL program, overall and by study arm. The investigators will calculate change in patient outcomes based on patients' pre- and post-program visits. Generalized linear mixed effect models including all time points for patient outcomes will be fit to account for clustering of patients within site and repeated measures of patient outcomes.
Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either foundational support or foundational support plus the Reach+Equity bundle. The investigators will use generalized linear models to examine the effect of foundational vs. Reach+Equity on implementation outcomes at 18-months.
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 with foundational support versus the enhanced implementation strategy (Reach+Equity bundle).
Key questions. How can the Reach+Equity bundle be optimized? What are shareholder perspectives on the refinements needs for SWELL foundational activities, as well as strategies to enhance equitable reach (Reach+Equity bundle)? Are there differences in implementation outcomes (reach, fidelity, adoption, cost) at six, 12, and 18 months between arms? Is reach representative of Veterans experiencing chronic insomnia at participating sites (equitable reach) and does this differ between arms? Are there differences in effectiveness outcomes (insomnia severity, function) between arms? How do sites experience implementation strategies in each arm? To address the question: Are there differences in implementation outcomes (reach \[primary\], fidelity, adoption) between arms? The investigators will use generalized linear models to examine the effect of foundational REP vs. Reach+Equity on implementation outcomes of reach and fidelity at 6, 12, and 18-months (primary). The investigators will examine how implementation outcomes change over time using descriptive methods (e.g. plots, descriptive statistics, subgroups). The investigators will compare average time to adoption between study arms. The investigators will examine equitable reach by calculating participation to prevalence ratios (PPRs) by site and implementation arm. The investigators will explore ratios by rurality and gender as well as race, sex and age. To address the question: Are there differences in effectiveness outcomes (insomnia symptoms, function) between arms, the investigators will describe effectiveness outcomes for patients who initiate the SWELL program, overall and by study arm. The investigators will calculate change in patient outcomes based on patients' pre- and post-program visits. Generalized linear mixed effect models including all time points for patient outcomes will be fit to account for clustering of patients within site and repeated measures of patient outcomes.
Methodology. To evaluate implementation, the investigators will randomize sites (n=20) 1:1 to either foundational support or foundational support plus the Reach+Equity bundle. The investigators will use generalized linear models to examine the effect of foundational vs. Reach+Equity on implementation outcomes at 18-months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: