Cognitive Behavioral Therapy for Insomnia

(SWELL Trial)

Overseen By Caitlin B Kappler, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Under 60, Uncontrolled seizures, Bipolar I, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well Cognitive Behavioral Therapy (CBT) treats insomnia in older veterans. The goal is to determine the most effective delivery method and ensure fairness and effectiveness for all participants. Participants will receive either foundational support or an enhanced strategy aimed at broader, equitable reach. This trial suits veterans with long-term sleep difficulties who do not have health issues that make therapy risky, such as uncontrolled seizures or severe psychiatric conditions. As an unphased trial, it offers veterans the chance to contribute to research that could enhance sleep therapy options for their community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Cognitive Behavioral Therapy for Insomnia is safe for older veterans?

Studies have shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is both effective and safe. Research indicates that CBT-I often surpasses medication in treating insomnia and offers long-lasting benefits. Reviews of multiple studies suggest it is also effective for older adults.

However, some downsides exist. Some individuals might feel tired or less motivated after CBT-I. Overall, it is considered one of the safest treatments for insomnia, particularly because it doesn't involve drugs. For any concerns, consulting a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance Cognitive Behavioral Therapy for Insomnia (CBT-I). Unlike typical CBT-I, which may not always consider diverse implementation challenges, the "Reach+Equity Bundle" arm introduces external facilitation and an equity-focused toolkit. These features aim to address barriers and ensure fair access to therapy, allowing researchers to explore how equitable delivery can improve treatment reach and effectiveness. The trial's focus on equity and data-driven monitoring could lead to more inclusive and effective insomnia treatments in the future.

What evidence suggests that Cognitive Behavioral Therapy for Insomnia could be effective for older veterans?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is a highly effective treatment. Studies have found that CBT-I helps people fall asleep faster and stay asleep longer, enhancing overall sleep quality. In some cases, it works as well as sleep medication but without the side effects. Participants in various studies have experienced significant improvements in their insomnia symptoms, with benefits lasting for years. This trial will compare two approaches: the Foundational Support arm, which uses the Replicating Effective Program (REP) implementation strategy, and the Reach+Equity Bundle arm, which includes additional activities focused on equitable reach. Overall, CBT-I has a strong record of helping people with insomnia sleep better. ^{2 6 7 8 9}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for older veterans experiencing insomnia or sleep disorders. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

Absence of a CBTI contraindication (i.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)

I can join SWELL on my own or through my doctor's recommendation.

I have been diagnosed with or meet the criteria for chronic insomnia.

Exclusion Criteria

Do not meet criteria for enrollment

I am younger than 60 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Behavioral Therapy for Insomnia (CBTI) through the SWELL program, involving five weekly sessions with a trained provider.

5 weeks

5 visits (in-person)

Implementation Evaluation

Evaluation of implementation strategies, including foundational support and Reach+Equity bundle, across 20 VA facilities.

18 months

Follow-up

Participants are monitored for effectiveness and implementation outcomes, including reach, fidelity, and adoption.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview The trial is testing two implementation strategies for Cognitive Behavioral Therapy (CBT) for Insomnia among veterans: Foundational Support and Reach+Equity Bundle. It aims to compare these approaches using a type III effectiveness-implementation hybrid study with a parallel CRT design.

How Is the Trial Designed?

Group I: Reach+Equity Bundle Experimental Treatment 1 Intervention

The Reach+Equity bundle will include the same activities as foundational support plus the Reach+Equity bundle activities which include: 1) external facilitation (designed to provide an outside perspective to help sites identify barriers, develop effective strategies, and navigate complex change processes particularly through the lens of achieving equitable reach); 2) equity in implementation toolkit (guide that supports awareness and consideration of equitable program reach and delivery during the implementation process); and 3) equity-focused data-driven monitoring (inform progress regarding equitable reach-related goals).

Group II: Foundational Support Active Control 1 Intervention

Foundational Support uses the Replicating Effective Program (REP) implementation strategy and includes 5 elements that were developed and tested in our prior Function QUERI work: shareholder engagement, SWELL toolkit, online shared resources (SharePoint) access for clinical program training materials, data reports to assist sites with tracking their data, and Diffusion Networks to promote peer-to-peer sharing and implementation support.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

Cognitive-Behavioral Therapy for Insomnia: An Effective ... Total sleep time improved by 8 minutes, and sleep efficiency improved by 10%. CBT-i produces results that are equivalent to sleep medication, with no side ...

2. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11756

main outcomes of a randomized dismantling trial All groups exhibited insomnia symptom reduction at posttreatment (CT: d = −2.53, P < .001; BT: d = −2.39, P < .001; CBT: d = −2.90, P < .001) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001284

Network meta-analysis examining efficacy of components ... The current results suggest that sleep restriction therapy and stimulus control therapy are the most effective components of CBT-I.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823907

Voice-Activated Cognitive Behavioral Therapy for Insomnia Previous studies have shown the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), but high insomnia prevalence suggests ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/16506073.2021.2009019

Very long-term outcome of cognitive behavioral therapy for ... Positive effects of CBT were still present after ten years. Insomnia severity remained low, and two-thirds of participants no longer fulfilled criteria for an ...

6. kosinmedj.org kosinmedj.org/journal/view.php?number=1311

a focus on components of cognitive behavioral therapy for ... Thus, CBT-I is considered the most effective and safest treatment for insomnia [4].

7. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725001133

Negative effects of cognitive behavioral therapy for insomnia Evidence exists that cognitive behavioral therapy for insomnia (CBT-I) can lead to negative effects (e.g., exhaustion, reduced motivation).

8. nature.com nature.com/articles/s41746-025-01847-0

A randomized controlled trial of a digital cognitive ... Meta-analyses support CBT-I as efficacious and safe, with long-lasting effects in older adults. As a behavioral rather than pharmacological ...

9. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1413694/full

The efficacy of cognitive behavioral therapy for insomnia in ... In a direct comparison, CBT-I has been shown to be more effective than medication in managing insomnia, with effects lasting for at least 6 months of follow-up ...