Preventative CBT for Insomnia

Overseen By Alec Bayoneto, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Under 18, Bipolar, Seizure, 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: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special kind of talk therapy, called preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I), can prevent insomnia and depression from worsening. Participants in the therapy group will fill out sleep diaries and receive personalized sleep advice during a telehealth session. Another group will receive digital tips for improving sleep. The trial seeks individuals who have trouble sleeping and feel anxious about it, particularly those with a low income or less formal education. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance mental health treatments.

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 this protocol is safe for treating insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is both effective and safe. Studies indicate it is well-tolerated and offers long-lasting benefits, particularly for older adults. Unlike medications, CBT-I does not involve drugs, typically resulting in fewer side effects.

Digital versions of CBT-I have also proven to be safe and effective, offering a convenient way to treat insomnia. Participants who have used digital CBT-I report improved sleep quality without major issues.

Overall, health organizations worldwide recommend CBT-I as the first choice for treating insomnia. Although the digital and in-person formats differ, both are considered equally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) because it offers a proactive approach to improving sleep quality before insomnia becomes chronic. Unlike standard treatments like medication or traditional CBT for insomnia, this method includes a unique telehealth session with a nurse coach, providing personalized sleep recommendations. This approach not only focuses on immediate sleep improvements but also empowers participants with tools to manage their sleep long-term, making it a promising preventative strategy against chronic insomnia.

What evidence suggests that pCBT-I might be an effective treatment for insomnia?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) works as well as sleep medication but without the side effects. It also continues to improve sleep patterns over time. Studies indicate that CBT-I helps people fall asleep faster, sleep longer, and spend more of their time in bed actually sleeping. In this trial, participants in the Preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) arm will receive personalized sleep recommendations to improve sleep quality. One study found that a one-week online CBT-I program can effectively stop short-term insomnia from becoming long-term. These findings suggest that using CBT-I early on could be a powerful way to manage and prevent insomnia from worsening. ^{4 6 7 8 9}

Who Is on the Research Team?

Philip Cheng, Ph.D.

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for adults with a low income or education level who are starting to have trouble sleeping and feel worried about it. It's not for those under 18, people who can't participate, or if they have other untreated sleep issues or serious health problems.

Inclusion Criteria

I have trouble sleeping and it worries or distresses me.

Individuals with low socioeconomic position as defined by income (<35k annual household income) or education (high school diploma or less)

Exclusion Criteria

I have severe health or mental health conditions that I haven't treated.

I am not willing or able to participate in the trial.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a virtual pCBT-I session with a nurse coach or digital sleep education

1 week

1 virtual session

Follow-up

Participants are monitored for insomnia and depression severity post-treatment

6 months

Extended Follow-up

Participants are further monitored for insomnia and depression severity

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• pCBT-I

Trial Overview

The study tests whether a one-time virtual therapy session of preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) can reduce the severity of early insomnia symptoms and prevent them from getting worse.

How Is the Trial Designed?

Group I: Preventative Cognitive Behavioral Therapy for Insomnia Experimental Treatment 1 Intervention

Participants in this group will complete daily sleep diary entries for one week, and then have a telehealth pCBT-I session with a nurse coach, where they will receive personalized sleep recommendations to improve sleep quality.

Group II: Digital Sleep Education Control Active Control 1 Intervention

Participants in this group will receive digital sleep education, including tips on how to improve your sleep via interactive email. These materials are selected to help prevent chronic insomnia.

pCBT-I is already approved in United States, European Union for the following indications:

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

• Insomnia
• Acute Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Chronic Insomnia

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

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]

Cognitive-behavioral therapy for insomnia (CBT-I) is the preferred treatment for chronic insomnia, but it faces challenges such as a lack of trained therapists and a low response rate among patients.

Alternative methods to CBT-I, including bibliotherapy, phone psychotherapy, brief behavioral therapy, and online CBT-I, are gaining interest, and hypnotics can be used alongside CBT-I to enhance its effectiveness or as a standalone treatment when CBT-I is not accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioral therapy and pharmacotherapy for chronic insomnia]. Pchelina, PV., Poluektov, MG.[2019]

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) 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 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) 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]

Internet-based cognitive-behavioral therapy for insomnia (ICBT-i) significantly improves sleep outcomes in adults, with participants experiencing a decrease in sleep onset latency by 18.41 minutes and an increase in total sleep time by 22.30 minutes based on a meta-analysis of 15 studies involving 1013 participants.

ICBT-i also enhances sleep efficiency by 9.58% and reduces wake after sleep onset by 22.31 minutes, demonstrating its effectiveness as a treatment for insomnia that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive-behavioural therapy for insomnia (ICBT-i): a meta-analysis of randomised controlled trials. Ye, YY., Chen, NK., Chen, J., et al.[2019]

The French-speaking automated Internet-delivered CBT-I (eCBT-I) program significantly reduced insomnia severity compared to minimal psychoeducation therapy (mPT) in a study of 46 adults over 12 weeks.

Participants in the eCBT-I group also experienced improvements in depressive symptoms, fatigue, anxiety, and quality of life, with a high percentage reducing or stopping their use of CNS-active medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

French Language Online Cognitive Behavioral Therapy for Insomnia Disorder: A Randomized Controlled Trial. Lopez, R., Evangelista, E., Barateau, L., et al.[2023]

In a study of 83 chronic insomnia patients, factors such as shorter insomnia duration, female gender, high health-related quality of life, and higher engagement (measured by total clicks) were linked to better outcomes from internet-based cognitive behavioral therapy for insomnia (iCBT-I).

The presence of dysfunctional beliefs and attitudes about sleep (DBAS) improved treatment effects specifically for the multicomponent iCBT-I, suggesting that assessing these beliefs can help tailor therapy to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided Internet-Based Cognitive Behavioral Therapy for Insomnia: Prognostic and Treatment-Predictive Factors. Pchelina, P., Duss, SB., Bernasconi, C., et al.[2023]

The HUS Helsinki University Hospital-iCBT for Insomnia program demonstrated significant effectiveness in treating insomnia, with 75.4% of the 2,464 patients completing the treatment and an average decline of 7.04 points on the Insomnia Severity Index (ISI).

A large proportion of participants (34.0%) achieved remission by the end of the treatment, and the effect size was substantial (Cohen's d = -1.449), indicating that this publicly funded, therapist-supported program is effective in routine care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mobile-delivered, therapist-assisted cognitive behavioral therapy for insomnia in nationwide routine clinical care in Finland. Stenberg, JH., Ritola, V., Joffe, G., et al.[2023]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

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 behavioural therapy for insomnia (CBT-I) delivered through a computerized format (CCBT-I) could improve access to treatment, as it addresses the shortage of trained providers, according to interviews with 23 health professionals and 28 patients.

To enhance the effectiveness and adherence to CCBT-I, the program must focus on building trust through accreditation and evidence of effectiveness, while also incorporating features like mobile access, self-assessment tools, and moderated peer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating online communities and social networks with computerised treatment for insomnia: a qualitative study. Middlemass, J., Davy, Z., Cavanagh, K., et al.[2023]

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]

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