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Sleep Healthy Using the Internet (SHUTi) for Chronic Insomnia

N/A
Waitlist Available
Led By David L Brody, MD, PhD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Service member or veteran
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks; 3 months
Awards & highlights

Study Summary

This trial will test if an internet-guided CBT-I program can help improve insomnia and quality of life outcomes in active or retired service members with primary insomnia and associated mild traumatic brain injury.

Eligible Conditions
  • Chronic Insomnia
  • Concussion

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are an active-duty military member or a veteran.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks; 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks; 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index (ISI)
Secondary outcome measures
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Migraine Disability Assessment (MIDAS)
PTSD Checklist for DSM-5 (PCL-5)
+3 more
Other outcome measures
Blinding efficacy
Concurrent Medications
Participant Expectations
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: ControlExperimental Treatment1 Intervention
Education control program
Group II: Active CBT-IExperimental Treatment1 Intervention
Internet-guided cognitive behavioral therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Healthy Using the Internet (SHUTi)
2008
N/A
~190

Find a Location

Who is running the clinical trial?

Center for Neuroscience and Regenerative Medicine (CNRM)FED
23 Previous Clinical Trials
5,366 Total Patients Enrolled
Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
92 Previous Clinical Trials
92,484 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,291 Total Patients Enrolled

Frequently Asked Questions

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

Is the age limit for this trial set at 75 years or younger?

"Eligibility for this particular trial requires that patients be aged 18 to 64. Out of the 906 trials available for seniors, and the 196 trials designed specifically for children, this is one of the few options available to young adults."

Answered by AI

How can I become a subject in this clinical trial?

"This trial is looking for 125 patients that have suffered a brain concussion in the past. The requirements for applicants are as follows: they must be between 18 and 64 years old, have reliable access to a telephone and the internet, be able to follow study-related instructions, and have a history of mild traumatic brain injury confirmed by a telephone administered screener."

Answered by AI

Are investigators still looking for new participants for this trial?

"Unfortunately, this particular study is no longer looking for volunteers as it is not actively recruiting. However, there are 1179 other trials that might be a better match for you and your needs."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Uniformed Services University
What portion of applicants met pre-screening criteria?
Did not meet criteria
~27 spots leftby Mar 2025