Cognitive Behavioral Therapy for Insomnia

(CBTBI Trial)

Overseen By Anice Byrd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Noctem, LLC

Must be taking: Psychotropic, Hypnotic

Disqualifiers: Severe TBI, Alcohol use disorder, Bipolar, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Cognitive Behavioral Therapy for Insomnia (CBT-I) can assist active-duty sailors with sleep difficulties due to past head injuries (traumatic brain injury, or TBI). Researchers compare traditional in-person CBT-I and a digital version called COAST against usual treatment. The goal is to determine if CBT-I can improve insomnia, mental health, and brain function. Eligible participants include active-duty Navy personnel with a history of TBI and chronic insomnia. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance treatment options for insomnia related to TBI.

Will I have to stop taking my current medications?

You can continue taking your current psychotropic and hypnotic medications if you have been on the same dose for at least 8 weeks and there are no expected changes during the trial. The study will track any medication changes, but you don't need to stop taking them.

What prior data suggests that Cognitive Behavioral Therapy for Insomnia (CBT-I) is safe for active-duty sailors with a history of traumatic brain injury?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) safely helps people with sleep problems. Studies have identified it as the top choice for treating long-term insomnia due to its safety. CBT-I proves effective and manageable whether delivered in person or through digital tools like apps or online platforms. Both in-person CBT-I and CBT-I via the COAST platform are equally safe. No reports of serious side effects have emerged from these methods, making them a reliable way to improve sleep without the risks often associated with medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Behavioral Therapy for Insomnia (CBT-I) trial because it explores new and flexible ways of delivering this therapy. Unlike standard insomnia treatments, which often involve medication or traditional in-person therapy sessions, this trial examines CBT-I delivered in-person and via COAST (an online platform). This approach could make effective insomnia treatment more accessible to people who have difficulty attending in-person sessions, potentially broadening the reach and impact of CBT-I. Additionally, CBT-I addresses insomnia by changing sleep-related thoughts and behaviors, offering a non-pharmacological alternative without the side effects associated with medications.

What evidence suggests that this trial's treatments could be effective for insomnia?

This trial will compare different approaches to Cognitive Behavioral Therapy for Insomnia (CBT-I). Studies have shown that CBT-I effectively helps individuals with sleep problems. One study found that CBT-I benefits patients with insomnia, even if they have other health issues. Research also shows that CBT-I can improve sleep quality, sleep efficiency, and sleep duration. In this trial, participants may receive CBT-I in-person or via digital platforms like COAST. Both in-person and digital CBT-I show promise in reducing insomnia symptoms and improving sleep. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for active-duty sailors who have experienced a traumatic brain injury (TBI) and are struggling with insomnia. Participants should be currently serving, have a history of TBI, and suffer from sleep problems. Details on specific inclusion or exclusion criteria were not provided.

Inclusion Criteria

Active duty Sailors and activated Reservist Sailors

History of TBI confirmed by study evaluators

Own a smart device for using the COAST app

Exclusion Criteria

Inability to comprehend or read English

Serious mental health diagnosis such as bipolar disorder or psychosis, or seizure disorder

Potential alcohol use disorder

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 (CBT-I) either in-person or via the COAST platform for 6 weeks

6 weeks

Weekly sessions

Post-treatment Assessment

Participants are assessed within 10 days after the treatment phase to evaluate insomnia, post-concussive symptoms, and psychological health

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness 3 months after treatment

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia (CBT-I)

Trial Overview The study compares Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered in person versus through a digital platform called COAST against usual treatment. It aims to see how each method affects sleep issues, post-concussive symptoms, thinking abilities, and mental health.

How Is the Trial Designed?

Group I: In-Person CBT-I Experimental Treatment 1 Intervention

Group II: CBT-I via COAST Experimental Treatment 1 Intervention

Group III: Treatment as Usual Active Control 1 Intervention

Participants will receive only TBI-related interventions. No insomnia-specific interventions will be provided.

Who Is Running the Clinical Trial?

Noctem, LLC

Lead Sponsor

Trials

3

Recruited

370+

Naval Health Research Center

Collaborator

Trials

21

Recruited

177,000+

United States Naval Medical Center, San Diego

Collaborator

Trials

110

Recruited

24,200+

Published Research Related to This Trial

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

A single 4-hour group workshop on cognitive behavioral treatment for insomnia (CBT-I) significantly improved insomnia symptoms in 45 participants, with Insomnia Severity Index scores dropping from an average of 20.09 to 11.89 after one month.

Participants also reported a reduction in sleep aid use, with 80% indicating better sleep quality and 20% achieving remission of insomnia, highlighting the effectiveness of this accessible treatment format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. Okun, ML., Glidewell, RN.[2023]

Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for chronic primary insomnia, which affects about 10% of adults and is associated with various health risks.

There is ongoing research into extending CBT-I to patients with insomnia related to medical and psychiatric conditions, but there is currently no consensus on the criteria for determining suitable candidates for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who is a candidate for cognitive-behavioral therapy for insomnia? Smith, MT., Perlis, ML.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) is recognized as the best treatment for chronic insomnia, yet it is significantly underutilized despite the high number of people affected by insomnia disorder.

The article highlights the need for further research on how to effectively deliver CBT-I, identify suitable candidates for the therapy, and measure the quality of care provided, which are essential for improving its real-world application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. Buenaver, LF., Townsend, D., Ong, JC.[2019]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep quality, sleep onset, and sleep efficiency in 76 patients with primary insomnia over a 6-week group course in a clinical setting.

CBT-I also led to reductions in medication use and improvements in patients' overall health and cognitive functioning, highlighting its effectiveness beyond just sleep improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. Van Houdenhove, L., Buyse, B., Gabriels, L., et al.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.

While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep parameters in 51 patients with chronic insomnia, including reductions in sleep latency, number of awakenings, and overall sleep quality, with effects lasting for at least 3 months after treatment.

Post-treatment, patients with insomnia showed no significant differences in sleep quality and mental health symptoms compared to healthy controls, indicating that CBT-I can effectively restore normal sleep patterns and improve overall functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for chronic insomnia]. Fornal-Pawłowska, M., Szelenberger, W.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) is recognized as the first-line treatment for both uncomplicated insomnia and insomnia associated with other chronic disorders, demonstrating its broad efficacy.

This review aims to summarize efficacy data across various clinical and demographic factors and to outline future research and implementation strategies for CBT-I, highlighting its importance in treating sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? Muench, A., Vargas, I., Grandner, MA., et al.[2022]

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6858181/

Economic evaluation of cognitive behavioural therapy for ... Cognitive behavioural therapy for insomnia (CBT-I) is a promising intervention that can improve outcomes in people who suffer from insomnia.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079220300940

Economic evaluation of cognitive behavioural therapy for ... We found that CBT-I is a cost-effective intervention for insomnia compared to control, highlighting the importance of promoting awareness and access to this ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4945317/

Cost-Effectiveness of Group and Internet Cognitive ... This is the first study to show that group- and Internet-delivered cognitive behavioral therapy for insomnia (CBTI) are equally effective in improving ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803668

Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

5. journals.lww.com journals.lww.com/jaapa/fulltext/2020/12000/assessing_the_effectiveness_of_online_cognitive.17.aspx

Assessing the effectiveness of online cognitive behavioral... The purpose of this systematic review and meta-analysis was to evaluate and quantify current evidence regarding the efficacy of online CBTi for treating adults ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia CBT-I is a structured multimodal intervention specifically designed for insomnia that combines cognitive restructuring with behavioral ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357470/

Digitally delivered cognitive behavioral therapy for ... The DMC will review safety data, such as AEs in relation to ear-EEG reported by telephone calls or written reports via letter or email by the participants.

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

Voice-Activated Cognitive Behavioral Therapy for Insomnia This randomized clinical trial investigates whether in-home delivery of a daily voice-activated cognitive behavioral therapy program ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01549899

Comparing Internet and In-Person Brief Cognitive ... The objective of this study is to directly compare 6 sessions of in-person and Internet administered Cognitive-Behavior Therapy for Insomnia (CBTi) to a ...

10. 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 ...