Enhanced Digital CBT-I for Insomnia

(COACH Trial)

Overseen By Marleigh Treger, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital treatment for individuals with insomnia, focusing on participant adherence to the program. The study compares two groups: one using the standard digital program and another receiving additional support from a coach. The goal is to determine what enhances engagement with the treatment. It suits those with persistent sleep difficulties but not those with untreated sleep disorders or severe mental health issues. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance insomnia treatments for many.

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 digital therapy is safe for treating insomnia?

Research has shown that Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) is generally safe and easy for most people to use. Studies have found that this digital method effectively improves sleep for those with sleep issues. Serious side effects rarely occur, and most people manage the treatment well.

Enhanced dCBT-I includes coaching support along with the digital therapy. This added coaching helps people complete the treatment without introducing extra risks. Overall, the therapy is considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced dCBT-I for insomnia because it combines digital cognitive behavioral therapy with personalized coaching. Unlike standard digital CBT, which patients complete on their own, this treatment offers support from a coach who can address questions and help overcome hurdles. This personalized approach aims to enhance adherence and effectiveness, making it a promising option for those who struggle with traditional self-guided methods.

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

Research has shown that digital cognitive behavioral therapy for insomnia (dCBT-I) is effective. Studies have found that 70% to 80% of people experience positive results from CBT-I, with about half seeing a significant reduction in symptoms. Over time, this treatment proves more effective than medication. Digital versions of CBT-I are particularly beneficial for older adults due to their accessibility and lasting benefits. In this trial, participants in the Enhanced dCBT-I arm will receive an improved version of dCBT-I, which includes a coach to enhance commitment and outcomes through personal support. Meanwhile, participants in the Control dCBT-I arm will complete dCBT-I individually without assistance from a healthcare provider. ^{1 4 6 7 8}

Who Is on the Research Team?

Philip A Cheng, PhD

Principal Investigator

Henry Ford Health System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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