[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07216261":3,"trial-entities:NCT07216261":111,"trial-summary:NCT07216261":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":51,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":77,"locations":80,"central_contacts":99,"overall_officials":104,"references":109,"see_also_links":110},"NCT07216261","QUX 25-004","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)","RECRUITING","2030-09-30","2026-05","2026-05-07","2026-04-30","VA Office of Research and Development","FED",false,"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\u002FPurpose. 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\u002For 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.\n\nCBTI 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.\n\nObjectives. 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.\n\nKey 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.\n\nMethodology. 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.",[19],"Chronic Insomnia",[21,22,23,24,25,26],"Sleep Disorders","Implementation Science","Functional Status","Quality of Life","Cognitive Behavioral Therapy","Veterans","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[30],"NA",{"count":32,"type":33},20,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"OTHER","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.",[40],"Foundational Arm",{"type":36,"name":42,"description":43,"armGroupLabels":44},"Implementation Strategy: REACH arm","The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.",[45],"REACH (Reach Equity And Collective Health) Arm",[47],{"measure":48,"description":49,"timeFrame":50},"Reach","Reach will be defined as the number of older Veterans who initiate SWELL at a site. Initiation is defined as completing the first SWELL treatment session.","18 months",[52,54,57,58],{"measure":48,"description":49,"timeFrame":53},"12 months",{"measure":55,"description":56,"timeFrame":53},"Patient Engagement","Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.",{"measure":55,"description":56,"timeFrame":50},{"measure":59,"description":60,"timeFrame":50},"Time to Adoption","Time to Adoption will be defined as the time from baseline to the time at which a site crosses the adoption threshold (Adoption is defined at 5 or more enrolled Veterans who have initiated SWELL). This will be computed for each site meeting the adoption criteria.","ALL","60 Years",null,{"inclusion":65,"exclusion":72,"raw_text":76},[66,67,68,69,70,71],"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.","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\u002For too medically or psychiatrically unstable to engage in a multi-session treatment opatients can be referred to SWELL by a clinician or self-referred",[73,74,75],"No members of the SWELL team working in the clinic","younger than 60","do not meet criteria for enrollment","Inclusion Criteria:\n\nSite Inclusion Criteria:\n\n* Facility is part of the U.S. Department of Veterans Affairs (VA) health system.\n* Primary care clinic providing care to older Veterans\n* Clinic is located 25 miles from the nearest other VA clinic participating in the program\n* Identified site champion (e.g., clinician or staff member) who is willing to assume required program responsibilities for implementation.\n\nPatient Inclusion Criteria:\n\n* meet diagnostic criteria for chronic insomnia disorder (with or without documented diagnosis)\n* absence of a CBTI contraindication oi.e., comorbid condition that makes CBTI unsafe), including uncontrolled seizure disorders, bipolar disorder I, and\u002For too medically or psychiatrically unstable to engage in a multi-session treatment opatients can be referred to SWELL by a clinician or self-referred\n\nExclusion Criteria:\n\nSite Exclusion Criteria:\n\n* No members of the SWELL team working in the clinic\n\nPatient Exclusion Criteria:\n\n* younger than 60\n* do not meet criteria for enrollment",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":96},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705-3875","United States",[88,93],{"name":89,"role":90,"phone":91,"email":92},"Heidi D Bassani","CONTACT","(919) 286-0411","Heidi.Bassani@va.gov",{"name":94,"role":95},"Jaime Hughes, PhD","PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},35.99403,-78.89862,[100],{"name":101,"role":90,"phone":102,"email":103},"Caitlin B Kappler, MSW","(919) 286-6936","Caitlin.Kappler@va.gov",[105,106],{"name":94,"affiliation":82,"role":95},{"name":107,"affiliation":108,"role":95},"Jennifer L Martin, PhD","VA Greater Los Angeles Healthcare System, Sepulveda, CA",[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[19],[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This study is an interventional trial that will compare two different ways of implementing a treatment. It is a cluster randomized trial, meaning groups of clinics will be assigned to different implementation strategies.","completed","Implementing Cognitive Behavioral Therapy for Insomnia (SWELL) for Older Veterans","This study, called SWELL, is looking at the best ways to bring an effective insomnia treatment to older Veterans. Many older Veterans experience chronic insomnia (difficulty sleeping for three months or more), which can affect their quality of life. The treatment being studied is Cognitive Behavioral Therapy for Insomnia (CBTI), which has been adapted for older Veterans and shown to improve sleep and daily functioning. The study will compare two approaches for implementing CBTI: a \"Foundational Arm\" with tools and training, and a \"REACH arm\" which includes everything in the Foundational Arm plus additional support. We want to see how well these approaches help clinics offer CBTI to more Veterans. The study plans to include 20 VA facilities and is currently unclear on its recruitment status.","The primary goal, \"Reach,\" will be measured at 18 months.",126,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]