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

Trial Summary

What is the purpose of this trial?

The objective of the study is to conduct a randomized controlled trial of Cognitive Behavioral Therapy for Insomnia (CBT-I) in a sample of active-duty sailors with a history of traumatic brain injury (TBI). The investigators will test the impact of CBT-I on insomnia symptoms as well as post-concussive symptoms, psychological symptoms, and neurocognitive functioning in comparison to treatment as usual. The investigators will also compare the effectiveness of traditional in-person CBT-I and CBT-I delivered via a clinician-supervised digital health platform, Clinician Operated Assistive Sleep Technology (COAST) in comparison to treatment as usual on symptoms of insomnia, post-concussive symptoms, neurocognitive functioning, and psychological health. Participants will be assessed at baseline, post-treatment, and 3 months later.

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I)?

Research shows that CBT-I is effective for improving sleep quality and reducing the need for sleep medication in people with both primary insomnia and insomnia related to other health issues. It is considered the first choice for treating chronic insomnia. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered safe and is recommended as the first-line treatment for insomnia, as it does not have the risks associated with sleeping medications. ^{1 6 7 8 9}

How is CBT-I treatment different from other treatments for insomnia?

CBT-I (Cognitive Behavioral Therapy for Insomnia) is unique because it is a non-drug treatment that focuses on changing sleep habits and behaviors, making it the first-line treatment for insomnia, even when it occurs alongside other health issues. Unlike medications, it addresses the root causes of insomnia and can be effective in a single session or over a longer period, depending on the individual's needs. ^{1 6 10 11 12}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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 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 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]

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) 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 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]

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) 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]

References

1. England pubmed.ncbi.nlm.nih.gov

We know CBT-I works, now what? [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

[Cognitive behavioral therapy for chronic insomnia]. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]

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

Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. [2019]

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

Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial. [2022]

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

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

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

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

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

Who is a candidate for cognitive-behavioral therapy for insomnia? [2022]

9. England 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). [2021]

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

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Improvement of Insomnia Symptoms following a Single 4-Hour CBT-I Workshop. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]