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Cognitive Behavioral Therapy

Enhanced Digital CBT-I for Insomnia (COACH Trial)

N/A

Recruiting

Led By Philip A Cheng, PhD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Unwillingness/inability to participate

Age < 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study until the final study visit, up to 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well a digital CBT-I program works to help people with insomnia, as well as what behavioral, physical, and sociocultural factors affect people's engagement with the treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a non-medical intervention focusing on behavioral therapy delivered digitally, traditional medication side effects are not applicable. However, participants may experience discomfort from changes in sleep patterns due to the therapy.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am willing and able to participate in the trial.

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I am under 18 years old.

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

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

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I have a history of bipolar disorder or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study until the final study visit, up to 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study until the final study visit, up to 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study until the final study visit, up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Sleep Restriction

Risk of treatment non-completion

Treatment Completion

Secondary study objectives

Insomnia

Physical Environment

Sociocultural environment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enhanced dCBT-IExperimental Treatment1 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-IActive Control1 Intervention

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

0 / 5Eligibility criteria met