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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study until the final study visit, up to 6 weeks
Awards & highlights

COACH Trial 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.Check my eligibility
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.See study design
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.

COACH Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to Sleep Restriction
Risk of treatment non-completion
Treatment Completion
Secondary outcome measures
Insomnia
Physical Environment
Sociocultural environment

COACH 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

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,282 Total Patients Enrolled
9 Trials studying Insomnia
623 Patients Enrolled for Insomnia
University of MichiganOTHER
1,797 Previous Clinical Trials
6,377,458 Total Patients Enrolled
9 Trials studying Insomnia
849 Patients Enrolled for Insomnia
National Jewish HealthOTHER
140 Previous Clinical Trials
315,636 Total Patients Enrolled
2 Trials studying Insomnia
2,121 Patients Enrolled for Insomnia

Media Library

Enhanced dCBT-I (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05182372 — N/A
Insomnia Research Study Groups: Control dCBT-I, Enhanced dCBT-I
Insomnia Clinical Trial 2023: Enhanced dCBT-I Highlights & Side Effects. Trial Name: NCT05182372 — N/A
Enhanced dCBT-I (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05182372 — N/A
Insomnia Patient Testimony for trial: Trial Name: NCT05182372 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new participants being admitted to this research endeavor?

"Correct. According to clinicaltrials.gov, this medical study is actively recruiting participants. Its first posting was on May 18th 2022 with the most recent update being June 29th 2022. 600 individuals will be recruited from 1 site for participation in the trial."

Answered by AI

How extensive is the pool of participants in this experiment?

"Affirmative. The clinical trial is currently accepting applications, as evidenced by its listing on clinicaltrials.gov which was first published May 18th 2022 and last modified June 29th 2022. It seeks to enlist 600 individuals from a single medical facility."

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
Michigan
What site did they apply to?
Henry Ford Columbus Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried numerous sleep meds to no avail. My current doctors keep switching me to different medications that are not working. I'm hoping that Cognitive Behavior Therapy can be utilized and will work for me.
PatientReceived no prior treatments
I have been on several different medications over the years, but I wake up several times during the night. When I get up, I am as tired as I was when I went to sleep.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many visits to your facility are required and for how long?
PatientReceived 1 prior treatment
~293 spots leftby Mar 2026