Enhanced Digital CBT-I for Insomnia

(COACH Trial)

Overseen By Alec Bayoneto, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Bipolar, Seizure, Untreated sleep, 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: 8

Duration: 6 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this research study is to increase adherence of Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). Additionally, this study will examine behavioral, physical, and sociocultural factors associated with treatment engagement.

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 data supports the effectiveness of the treatment Enhanced Digital CBT-I for Insomnia?

Research shows that Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) is effective in improving sleep quality, reducing insomnia severity, and enhancing overall well-being and quality of life. Studies have demonstrated that dCBT-I can lead to long-term benefits, including reduced use of sleep medication and improved psychological health. ^{1 2 3 4 5}

Is Enhanced Digital CBT-I for Insomnia safe for humans?

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has been studied in various trials and is generally considered safe for humans, with no significant safety concerns reported in the research available. ^{2 4 5 6 7}

How is the Enhanced Digital CBT-I treatment different from other insomnia treatments?

Enhanced Digital CBT-I is unique because it uses a digital platform to deliver cognitive behavioral therapy, making it more accessible and scalable than traditional in-person therapy. It not only improves sleep quality but also enhances overall well-being and quality of life, addressing both nighttime and daytime symptoms of insomnia. ^{1 2 3 4 5}

Research Team

Philip A Cheng, PhD

Principal Investigator

Henry Ford Health System

Eligibility Criteria

This trial is for adults with insomnia, as indicated by an Insomnia Severity Index (ISI) score over 14. It's not suitable for individuals under 18, those unwilling or unable to participate, or people with bipolar or seizure disorders. Also excluded are those with untreated sleep disorders other than insomnia and severe medical or psychiatric conditions.

Inclusion Criteria

Determination of insomnia (ISI >14)

Exclusion Criteria

I am willing and able to participate in the trial.

I am under 18 years old.

I have a sleep disorder other than insomnia that hasn't been treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive 6 weekly sessions of Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). Enhanced group receives additional telehealth coaching.

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for adherence and treatment engagement, including semi-structured interviews for some participants.

2 weeks

1-2 visits (virtual)

Treatment Details

Interventions

• Enhanced dCBT-I

Trial Overview The study is testing an enhanced version of Digital Cognitive Behavioral Treatment for Insomnia (dCBT-I). The goal is to improve how well patients stick to the treatment and understand factors that affect their engagement, including behavior, physical health, and social aspects.

Participant Groups

Group I: Enhanced dCBT-I Experimental Treatment 1 Intervention

This group will complete d-CBTI and be assigned a coach that will help with completion of the treatment and will be available to call personally to discuss questions and issues.

Group II: Control dCBT-I Active Control 1 Intervention

Participants in this group will complete dCBT-I individually without assistance from a healthcare provider

Enhanced dCBT-I is already approved in United States, United Kingdom for the following indications:

Approved in United States as Somryst for:

• Insomnia

Approved in United Kingdom as Sleepio for:

• 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+

National Jewish Health

Collaborator

Trials

145

Recruited

318,000+

Findings from Research

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.

The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., 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]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

A randomized controlled trial involving 101 adult patients with insomnia disorder found that fully automated digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) was significantly less effective than individual face-to-face Cognitive Behavioral Therapy for Insomnia (FtF CBT-I) in reducing insomnia severity at both 9 and 33 weeks, with dCBT-I showing inferior results.

At week 33, the mean difference in insomnia severity scores indicated that dCBT-I did not meet the non-inferiority criteria compared to FtF CBT-I, suggesting that while dCBT-I is a viable option, it may not be as effective as traditional therapy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy. Kallestad, H., Scott, J., Vedaa, Ø., et al.[2023]

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]

References

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

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

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

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]

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

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]

4. 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]

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

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]

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

Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy. [2023]

7. 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]