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.
12345What 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.
26789Is 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.
510111213Eligibility 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 18 years old or older.
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
+2 more
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
+8 more
Participant Groups
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.
2Treatment groups
Active Control
Group I: COAST-enhanced CBTIActive Control1 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 UsualActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Madigan Army Medical CenterLakewood, WA
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Who Is Running the Clinical Trial?
Noctem, LLCLead Sponsor
References
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]Computerized or online cognitive behavioral therapies (CBTs) are increasingly being developed to deliver insomnia therapy (CBT-i). They seek to address the difficulty of delivering an evidence-based technology to a large number of patients at low cost. Previous online applications have shown significant but variable improvements in sleep efficiency and a decrease in insomnia severity when compared with control groups. The best online methodology remains debated, and there are no such applications currently available within the UK National Health Service.
Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]Chronic insomnia is preferably treated with cognitive behavioral therapy for insomnia (CBTI), but many insomnia sufferers receive medication instead, likely because of high costs, lack of knowledge about optimal insomnia treatment among physicians, and lack of CBTI-trained professionals in mental health care. A possible solution is to offer CBTI through the Internet: I-CBTI. I-CBTI is generally acceptable to patients and greatly improves insomnia symptoms. We review the state of knowledge around I-CBTI and its effects. CBTI's effectiveness is influenced by treatment characteristics and patient-specific factors. We review potential factors that help identify which patients may benefit from I-CBTI.
Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2019]Chronic insomnia is preferably treated with cognitive behavioral therapy for insomnia (CBTI), but many insomnia sufferers receive medication instead, likely because of high costs, lack of knowledge about optimal insomnia treatment among physicians, and lack of CBTI-trained professionals in mental health care. A possible solution is to offer CBTI through the Internet: I-CBTI. I-CBTI is generally acceptable to patients and greatly improves insomnia symptoms. We review the state of knowledge around I-CBTI and its effects. CBTI's effectiveness is influenced by treatment characteristics and patient-specific factors. We review potential factors that help identify which patients may benefit from I-CBTI.
Internet-delivered CBT intervention (Space for Sleep) for insomnia in a routine care setting: Results from an open pilot study. [2021]Insomnia is a highly prevalent, often comorbid disorder associated with difficulties sleeping, remaining awake, and impaired quality of life. Internet-delivered Cognitive Behavioral Therapy for insomnia (ICBT-I) has the potential to help large numbers of people with sleep disorders. This study investigated the preliminary effects of an 8-week guided ICBT-I intervention within a routine stepped-care service. Fifty-six (N = 56) patients consented to participate. The primary outcome was assessed using the Insomnia Severity Index (ISI) and secondary outcome measures included the Patient Health Questionnaire 9-item (PHQ-9), Generalized Anxiety Disorder 7-item (GAD-7), and the Work and Social Adjustment Scale (WSAS), each administered at baseline and weekly thereafter. Intention-to-treat analyses indicated that ICBT-I produced statistically significant pre- to post- reductions in symptoms of insomnia, yielding within-group effects of d = 0.82 suggesting a potential for improved outcomes. Similar improvements were seen across secondary outcomes, with small-to-medium post-treatment within-group effects observed: depression (d = 0.63), anxiety (d = 0.39), and functional impairment (d = 0.31). These findings are supportive of the intervention's potential effectiveness and speak to the importance of several implementation factors that could enhance the effects of the intervention. The results contribute to the growing evidence base for digital interventions designed to help those with sleep difficulties and will inform the design of a future controlled evaluation of ICBT-I under routine clinical settings.
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]Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. Materials & methods:Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). Conclusion: This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. Clinical trial registration: NCT04325464 (ClinicalTrials.gov).
Insomnia and its effective non-pharmacologic treatment. [2018]Emerging data underscores the public health and economic burden of insomnia evidenced by increased health risks; increased health care utilization; and work domain deficits (absenteeism and reduced productivity). Cognitive behavioral therapy for insomnia (CBTi) is a brief and effective non-pharmacologic treatment for insomnia that is grounded in the science of sleep medicine and the science of behavior change and psychological theory, and in direct comparisons with sleep medication in randomized control trials that demonstrate that CBTi has comparable efficacy with more durable long-term maintenance of gains after treatment discontinuation. The high level of empirical support for CBTi has led the National Institutes of Health Consensus and the American Academy of Sleep Medicine Practice Parameters to make the recommendation that CBTi be considered standard treatment. The aim of this report is to increase awareness and understanding of health care providers of this effective treatment option.
Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]Insomnia disorder is present in as much as 30% of the general adult population. Given the significant adverse effects of pharmacotherapy, cognitive behavioral therapy (CBT) has been found to be an effective alternative in individuals with insomnia. CBT for insomnia (CBTi) encompasses sleep hygiene, stimulus control, sleep restriction, cognitive therapy, and relaxation training. In this article we review evidence that establishes CBTi as a useful treatment affecting remission, sleep onset latency, wakefulness after sleep, sleep efficiency, and sleep quality in adults with insomnia to include older adults and adolescents. In addition, we briefly highlight various CBTi delivery methods as well as barriers to accessing this safe and effective therapy.
New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]Insomnia is the most common sleep disorder. Psychological, behavioral, and biological factors are implicated in the development and maintenance of insomnia as a disorder, although the etiology of insomnia remains under investigation, as it is still not fully understood. Cognitive behavioral therapy for insomnia (CBTI) is a treatment for insomnia that is grounded in the science of behavior change, psychological theories, and the science of sleep. There is strong empirical evidence that CBTI is effective. Recognition of CBTI as the first-line treatment for chronic insomnia (National Institutes of Health consensus, British Medical Association) was based largely on evidence of its efficacy in primary insomnia. The aim of this article is to provide background information and review recent developments in CBTI, focusing on three domains: promising data on the use of CBTI when insomnia is experienced in the presence of comorbid conditions, new data on the use of CBTI as maintenance therapy, and emerging data on the delivery of CBTI through the use of technology and in primary care settings.
[Effectiveness of an online cognitive behavioral therapy for insomnia]. [2019]Insomnia is a common health problem with serious mental and physical consequences as well as increased economical costs. The use of hypnotics in Iceland is immense in spite of cognitive behavioral therapy for insomnia (CBT-I) being recommended as the first choice treatment of chronic insomnia. To meet the needs of more individuals suffering from insomnia, online CBT-I was established at betrisvefn.is. The objective of this research was to evaluate the effectiveness of this internet-based CBT-I.
PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. [2023]Cognitive behavioural therapy for insomnia (CBT-I) is effective at treating chronic insomnia, yet in-person CBT-I can often be challenging to access. Prior studies have used technology to bridge barriers but have been unable to extensively assess the impact of the digital therapeutic on real-world patient experience and multidimensional outcomes. Among patients with insomnia, our aim is to determine the impact of a prescription digital therapeutic (PDT) (PEAR-003b, FDA-authorised as Somryst; herein called PDT) that provides mobile-delivered CBT-I on patient-reported outcomes (PROs) and healthcare utilisation.
Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life.
The beneficial effects of integrating a personalized telephone-delivered component into digital cognitive behavioral therapy for insomnia in a large, hospital-based population. [2023]Although digital cognitive behavior therapy for insomnia (D-CBTI) has been shown to be a viable treatment for insomnia, lacking flexibility of response and direct practitioner-to-patient contact and comfort potentially limited its efficacy. Integrating personalized telephone sessions into D-CBTI may overcome these obstacles, potentially providing additional clinical benefit to chronic insomnia patients. We evaluate the clinical effectiveness of telephone plus D-CBTI (TD-CBTI) versus D-CBTI alone.
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]Individuals enrolling in the Veterans Health Administration frequently report symptoms consistent with insomnia disorder. Cognitive behavioral therapy for insomnia (CBT-I) is a gold standard treatment for insomnia disorder. While the Veterans Health Administration has successfully implemented a large dissemination effort to train providers in CBT-I, the limited number of trained CBT-I providers continues to restrict the number of individuals who can receive CBT-I. Digital mental health intervention adaptations of CBT-I have been found to have similar efficacy as traditional CBT-I. To help address the unmet need for insomnia disorder treatment, the VA commissioned the creation of a freely available, internet-delivered digital mental health intervention adaptation of CBT-I known as Path to Better Sleep (PTBS).