Chronic InsomniaSWELLNCT07216261
Implementing Cognitive Behavioral Therapy for Insomnia (SWELL): Function QUERI 3.0
A study testing Implementation Strategy: Foundational Arm and Implementation Strategy: REACH arm in people with Chronic Insomnia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Implementation Strategy: Foundational Arm and Implementation Strategy: REACH arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Heidi D Bassani, (919) 286-0411, Heidi.Bassani@va.gov
Jaime Hughes, PhD
About this study
Official title: 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.
Read the 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 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.
- Conditions
- Chronic Insomnia
- Being tested
- Implementation Strategy: Foundational Arm, Implementation Strategy: REACH arm
- Keywords
- Sleep Disorders, Implementation Science, Functional Status, Quality of Life, Cognitive Behavioral Therapy, Veterans
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Strategy: Foundational ArmOther
The Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports, and education and training.
Implementation Strategy: REACH armOther
The REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation.
| Study group | Role | What they receive |
|---|---|---|
| Foundational Arm | Active comparator | Foundational Arm uses the Replicating Effective Program (REP) implementation strategy and includes 3 elements that were developed and tested in our prior Function QUERI work: program initiation, self-guided resources, and technical assistance. Receives: Other: Implementation Strategy: Foundational Arm |
| REACH (Reach Equity And Collective Health) Arm | Experimental | The REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring. Receives: Other: Implementation Strategy: REACH arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
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.
Measured: 12 months
Patient Engagement
Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.
Measured: 12 months
Patient Engagement
Patient engagement will be defined as the mean number of SWELL sessions completed per enrolled older Veteran per site.
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start30 Apr 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to one of two interventions: Foundational support only (active comparator) vs. Foundational support plus Reach+Equity Implementation Bundle (experimental).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jaime Hughes, PhD, Principal investigator, Durham VA Medical Center, Durham, NCJennifer L Martin, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216261
- Sponsor's protocol ID
- QUX 25-004
- Acronym
- SWELL
- Status last verified
- May 2026
- First submitted
- 2 Oct 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that includes variables from statistical models presented in publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Cognitive Behavioral Therapy for Insomnia With Older Veterans: Function QUERI 3.0 (QUE 25-008)
- ClinicalTrials.gov ID
- NCT07216261
- Acronym / sponsor ID
- SWELL / QUX 25-004
- Conditions
- Chronic Insomnia
- Keywords
- Sleep Disorders, Implementation Science, Functional Status, Quality of Life, Cognitive Behavioral Therapy, Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel cluster-randomized trial (parallel-CRT): used in pragmatic evaluations of health program or policy interventions, where half the clusters (in this case, VA sites) are randomly assigned to one of two interventions: Foundational support only (active comparator) vs. Foundational support plus Reach+Equity Implementation Bundle (experimental).
| Arm | Type | Receives |
|---|---|---|
| Foundational Arm | Active comparator | Other: Implementation Strategy: Foundational ArmFoundational Arm uses the Replicating Effective Program (REP) implementation strategy and includes 3 elements that were developed and tested in our prior Function QUERI work: program initiation, self-guided resources, and technical assistance. |
| REACH (Reach Equity And Collective Health) Arm | Experimental | Other: Implementation Strategy: REACH armThe REACH Arm will include the same activities as the foundational arm plus REACH activities: 1) external facilitation and 2) equity-focused data-driven monitoring. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- No members of the SWELL team working in the clinic
- younger than 60
- do not meet criteria for enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation Strategy: Foundational ArmThe Foundational Arm includes the following activities: Toolkit, kickoff call, SharePoint, TEAMS channel, office hours calls, site specific data reports, and education and training. | Other | Foundational Arm |
| Implementation Strategy: REACH armThe REACH Arm includes everything in the Foundational Arm, plus additional components: targeted data reports and external facilitation. | Other | REACH (Reach Equity And Collective Health) Arm |
Primary outcome
Reach
Time frame: 18 months
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.
4 secondary outcomes
Reach
Time frame: 12 months
Patient Engagement
Time frame: 12 months
Patient Engagement
Time frame: 18 months
Time to Adoption
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be available upon request. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form. The statistician will create de-identified, publication-specific datasets that includes variables from statistical models presented in publication. Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re-identify any individual whose data are included in the dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaime Hughes, PhD principal investigator
Durham VA Medical Center, Durham, NC
Jennifer L Martin, PhD principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Strategy: Foundational Arm and Implementation Strategy: REACH arm in people with Chronic Insomnia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin B Kappler, MSW ((919) 286-6936, Caitlin.Kappler@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.