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Behavioral Intervention

Preventative CBT for Insomnia

N/A
Recruiting
Led By Philip Cheng, Ph.D.
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 through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing whether preventative CBT for insomnia can help reduce the severity and progression of acute insomnia and depression, and to understand what factors may play a role in developing insomnia and/or engaging with treatment plans.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since pCBT-I is a type of talk therapy, there aren't typical medication side effects. However, discussing sleep issues might temporarily increase worry or awareness about sleep patterns.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cases of Clinically Significant Depression
Cases of DSM-5 Insomnia
Depression Severity
+1 more
Secondary outcome measures
Physical Environment
Sociocultural Environment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Preventative Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 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 ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

University of MichiganOTHER
1,796 Previous Clinical Trials
6,377,673 Total Patients Enrolled
9 Trials studying Insomnia
1,169 Patients Enrolled for Insomnia
Henry Ford Health SystemLead Sponsor
300 Previous Clinical Trials
2,099,719 Total Patients Enrolled
9 Trials studying Insomnia
943 Patients Enrolled for Insomnia
Philip Cheng, Ph.D.Principal InvestigatorHenry Ford Health

Media Library

pCBT-I (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05523726 — N/A
Insomnia Clinical Trial 2023: pCBT-I Highlights & Side Effects. Trial Name: NCT05523726 — N/A
Insomnia Research Study Groups: Preventative Cognitive Behavioral Therapy for Insomnia, Digital Sleep Education Control
pCBT-I (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523726 — N/A
Insomnia Patient Testimony for trial: Trial Name: NCT05523726 — N/A

Frequently Asked Questions

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

Is this experiment presently enrolling participants?

"The clinicaltrials.gov database reveals that this trial, initially posted on December 1st 2022, is currently not recruiting participants. Nonetheless, there are still 228 other studies actively seeking individuals to join their trials."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
New Hampshire
How old are they?
18 - 65
What site did they apply to?
Henry Ford Columbus Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried several drugs to help me sleep and none have worked. I am currently taking medication to go to sleep and medication to keep my awake during the day. I am desperate to try Cognitive Behavior Therapy rather than medicine.
PatientReceived no prior treatments
I have tried many different medications, hypnosis, acupuncture, but nothing has provided relief. I am desperate for a non-medicine approach for my insomnia. Please consider me for this trial.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)
Philip Cheng 2022. "Preventing Insomnia With Virtual Oneshot Therapy (PIVOT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05523726.
All > Insomnia
~164 spots leftby May 2026
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