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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
No Placebo-Only Group

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cases of Clinically Significant Depression
Cases of DSM-5 Insomnia
Depression Severity
+1 more
Secondary study objectives
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: 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
1,857 Previous Clinical Trials
6,437,404 Total Patients Enrolled
10 Trials studying Insomnia
1,457 Patients Enrolled for Insomnia
Henry Ford Health SystemLead Sponsor
311 Previous Clinical Trials
2,176,086 Total Patients Enrolled
10 Trials studying Insomnia
1,434 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
~116 spots leftby May 2026