Digital CBTI for Chronic Insomnia

Overseen By Megan Wolfson, LCSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Noctem, LLC

Must be taking: Prescribed sleep medications

Disqualifiers: Untreated sleep disorder, Acute psychiatric distress, Active substance use, Psychotic or bipolar disorder, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks

188 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to insomnia care delivered as usual at three military treatment facilities for treatment of insomnia, symptoms of depression and anxiety, and treatment satisfaction.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop your current medications. However, if you are using prescribed sleep medications, you must have been on a stable dosage for at least 4 weeks and have no planned changes during the trial.

What data supports the idea that Digital CBTI for Chronic Insomnia is an effective treatment?

The available research shows that Digital CBTI for Chronic Insomnia is effective in improving sleep. One study found that online CBTI led to significant improvements in sleep efficiency and reduced insomnia severity. Another study highlighted that Internet-delivered CBTI is generally well-received by patients and greatly improves insomnia symptoms. Additionally, a pilot study demonstrated that an 8-week guided Internet-delivered CBTI intervention resulted in significant reductions in insomnia symptoms, as well as improvements in depression, anxiety, and daily functioning. These findings suggest that Digital CBTI can be a beneficial treatment for those with chronic insomnia. ^{1 2 3 4 5}

What safety data exists for digital CBT-I for chronic insomnia?

Cognitive Behavioral Therapy for Insomnia (CBT-I), including its digital forms, is considered a safe and effective treatment for chronic insomnia. It is recommended as the first-line treatment by major health organizations due to its strong empirical support and effectiveness in improving sleep quality and efficiency. CBT-I is a non-pharmacologic treatment that avoids the adverse effects associated with sleep medications. Studies have shown that CBT-I, including internet-delivered versions, is generally well-accepted by patients and provides durable long-term benefits. ^{2 6 7 8 9}

Is COAST-enhanced CBTI a promising treatment for chronic insomnia?

Yes, COAST-enhanced CBTI is a promising treatment for chronic insomnia. It is a digital version of Cognitive Behavioral Therapy for Insomnia (CBT-I), which is known to be effective. Digital CBT-I can be accessed more easily than in-person therapy, making it a good option for people who have trouble finding or attending traditional therapy sessions. Studies show that digital CBT-I can help improve sleep quality and overall well-being for people with insomnia. ^{5 10 11 12 13}

Research Team

Anne Germain

Principal Investigator

Noctem, LLC

Eligibility Criteria

This trial is for active duty service members aged 18 or older who have chronic insomnia and are cleared for Cognitive Behavioral Treatment of Insomnia (CBTI). They must not have any serious health issues that could affect their safety, and if they're taking sleep meds, the dose must be stable for at least 4 weeks. Participants also need a recent smartphone.

Inclusion Criteria

I am an active duty service member diagnosed with chronic insomnia and eligible for CBTI.

Absence of, or stable, psychiatric, or medical comorbidity(ies), such that they do not compromise safety when completing study procedures

Owning or ability to use a smartphone (iPhone or Android) that is no older than 5 years old (e.g., iPhone 6, and Android phone with Lollipop 5.0 mobile operating system)

Exclusion Criteria

Currently pregnant, breastfeeding, or being the parent of a newborn < 3 months old

Having planned or attempted suicide or the harming of others in the past 6 months

Past or current psychotic or bipolar disorder or sub-threshold symptoms of psychotic or bipolar disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either COAST-enhanced CBTI or insomnia care as usual

6-8 weeks

Regular virtual check-ins via the COAST platform or in-person visits for ICAU

Follow-up

Participants are monitored for changes in insomnia severity, depression, and anxiety symptoms

3 months

Follow-up assessments at 3 months

Treatment Details

Interventions

• COAST-enhanced CBTI
• Military Treatment Facility Insomnia Care As Usual

Trial Overview The study compares traditional insomnia care at military facilities with a new digital platform called COAST-enhanced CBTI to see which is better for treating insomnia, depression, anxiety symptoms, and patient satisfaction.

Participant Groups

Group I: COAST-enhanced CBTI Active Control 1 Intervention

Patients randomized to COAST will receive CBTI via the COAST platform, with the assistance of a licensed clinician via NOCTEM's digital sleep hub. Participants will utilize the COAST patient app on their smartphone for engagement in insomnia treatment and receipt of clinician's recommendations. COAST clinicians will utilize the COAST web-based portal for adherence monitoring, progress review, and for providing personalized insomnia treatment recommendations.

Group II: Military Treatment Facility Insomnia Care As Usual Active Control 1 Intervention

Patients randomized to the ICAU arm will receive insomnia care as usual by a certified clinician at their respective site, according to current referral and treatment practices.

COAST-enhanced CBTI is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Chronic Insomnia
• Symptoms of Depression
• Symptoms of Anxiety

Approved in European Union as Cognitive Behavioral Therapy for Insomnia for:

• Chronic Insomnia

Who Is Running the Clinical Trial?

Noctem, LLC

Lead Sponsor

Trials

3

Recruited

370+

Findings from Research

A study involving 75 participants with insomnia disorder showed that an interactive online cognitive behavioral therapy (CBT-i) significantly improved sleep efficiency and sleep latency, indicating its efficacy as a treatment option.

Rigorous screening revealed that 62% of those who accessed the therapy had other sleep disorders, highlighting the importance of proper assessment before starting treatment to ensure effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot evaluation of an online cognitive behavioral therapy for insomnia disorder - targeted screening and interactive Web design lead to improved sleep in a community population. Anderson, KN., Goldsmith, P., Gardiner, A.[2021]

Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment for chronic insomnia, but many patients opt for medication due to cost and availability issues.

Internet-based CBTI (I-CBTI) is well-accepted by patients and significantly improves insomnia symptoms, suggesting it could be a valuable alternative for those unable to access traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2020]

Internet-based cognitive behavioral therapy for insomnia (I-CBTI) is a highly acceptable treatment option that significantly improves insomnia symptoms for patients who may not have access to traditional CBTI.

The effectiveness of I-CBTI can vary based on specific treatment characteristics and individual patient factors, suggesting that tailoring the approach could enhance outcomes for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2019]

An 8-week guided Internet-delivered Cognitive Behavioral Therapy for insomnia (ICBT-I) showed significant reductions in insomnia symptoms among 56 participants, with a strong effect size of d = 0.82, indicating its potential effectiveness.

Improvements were also noted in related areas such as depression (d = 0.63), anxiety (d = 0.39), and functional impairment (d = 0.31), suggesting that ICBT-I may have broader benefits beyond just improving sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered CBT intervention (Space for Sleep) for insomnia in a routine care setting: Results from an open pilot study. Wogan, R., Enrique, A., Adegoke, A., et al.[2021]

The DREAM trial is a 9-week study involving 350 adults with chronic insomnia, evaluating the effectiveness of the digital therapeutic Somryst™ for delivering cognitive behavioral therapy for insomnia (CBT-I).

This study aims to demonstrate that a mobile, asynchronous digital CBT-I can effectively reduce self-reported insomnia symptoms and severity, potentially improving access to treatment for those who struggle to find traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia. Thorndike, FP., Berry, RB., Gerwien, R., et al.[2022]

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

Cognitive Behavioral Therapy for insomnia (CBTi) is an effective alternative to medication for treating insomnia, which affects up to 30% of adults, and has been shown to improve various sleep-related outcomes such as sleep onset latency and sleep quality.

CBTi includes techniques like sleep hygiene and cognitive therapy, making it a safe and beneficial option for both adults and adolescents, although access to this therapy can be limited by certain barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. Haynes, J., Talbert, M., Fox, S., et al.[2018]

Cognitive Behavioral Therapy for Insomnia (CBTI) is recognized as the first-line treatment for chronic insomnia, supported by strong empirical evidence of its effectiveness, particularly in cases of primary insomnia.

Recent developments in CBTI show promising results for treating insomnia alongside other health conditions, its use as a maintenance therapy, and the potential for delivering CBTI through technology and in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Siebern, AT., Manber, R.[2022]

An online cognitive behavioral therapy for insomnia (CBT-I) program was effective for 125 participants, showing significant improvements in sleep quality after 6 weeks, with effects maintained at follow-up.

The use of sleep medications decreased significantly among participants, suggesting that internet-based CBT-I could be a preferred first-line treatment for chronic insomnia, potentially reducing reliance on hypnotics and healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of an online cognitive behavioral therapy for insomnia]. Friðgeirsdóttir, G., Jóhannsson, G., Ellertsson, S., et al.[2019]

A multicentre randomized controlled trial is being conducted with 100 participants to evaluate the effectiveness of a prescription digital therapeutic (PDT) called Somryst, which delivers cognitive behavioural therapy for insomnia (CBT-I) via mobile devices.

The primary goal is to measure changes in insomnia severity after 9 weeks, while secondary outcomes will assess healthcare utilization and various patient-reported outcomes, including depressive symptoms and daytime sleepiness, providing comprehensive insights into the PDT's real-world impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. Dreyer, RP., Berkowitz, A., Yaggi, HK., et al.[2023]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

Integrating personalized telephone sessions with digital cognitive behavior therapy for insomnia (TD-CBTI) significantly improved treatment outcomes, leading to a 167% increase in the odds of achieving remission from insomnia compared to standard D-CBTI alone.

Patients receiving TD-CBTI also had a 352% higher likelihood of successfully reducing their sleep medication use, highlighting the added clinical benefits of personalized support in managing chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The beneficial effects of integrating a personalized telephone-delivered component into digital cognitive behavioral therapy for insomnia in a large, hospital-based population. Ren, R., Zhang, Y., Shi, Y., et al.[2023]

The Veterans Health Administration developed a digital mental health intervention called Path to Better Sleep (PTBS) to provide accessible cognitive behavioral therapy for insomnia (CBT-I) to veterans, addressing the shortage of trained providers.

Feedback from veteran and spouse evaluation panels significantly influenced the design of PTBS, leading to improvements in user engagement by emphasizing CBT-I efficacy, simplifying content, and incorporating relatable veteran testimonials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. Ryan, AT., Brenner, LA., Ulmer, CS., et al.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A pilot evaluation of an online cognitive behavioral therapy for insomnia disorder - targeted screening and interactive Web design lead to improved sleep in a community population. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Internet-delivered CBT intervention (Space for Sleep) for insomnia in a routine care setting: Results from an open pilot study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]

8. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]

9. Iceland pubmed.ncbi.nlm.nih.gov

[Effectiveness of an online cognitive behavioral therapy for insomnia]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The beneficial effects of integrating a personalized telephone-delivered component into digital cognitive behavioral therapy for insomnia in a large, hospital-based population. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

The Use of Evaluation Panels During the Development of a Digital Intervention for Veterans Based on Cognitive Behavioral Therapy for Insomnia: Qualitative Evaluation Study. [2023]